TREATMENTS IN THE PIPELINE: 150 headlines

2006-11-09T06:37:00.000-08:00

Pipex is developing oral Trimesta (estriol) for the treatment of relapsed/remitting multiple sclerosis
Pipex is developing oral Trimesta (estriol) for the treatment of relapsed/remitting multiple sclerosis. The drug, which has completed a Phase II study in that indication, is an estrogenic molecule, approved and marketed in Europe and Asia for the treatment of postmenopausal hot flashes for more than 40 years.

"MS patients who become pregnant have high rates of remission in the third trimester," Kanzer said. "Unfortunately, four to six weeks after delivering, they also have very high rates of relapse of their disease." Estriol - produced only during pregnancy - apparently confers immune benefits on the mother as well as the fetus.

Other investigators completed a 22-month Phase IIa trial that showed "very significant" reductions in the number and size of MS lesions, Kanzer said, and a trial by Pipex will start soon. MORE..oral Trimesta (estriol)

2006-11-08T21:42:00.000-08:00

Symadex Can Reverse Disease in Preclinical Multiple Sclerosis Animal Model
[ECTRIMS] "Xanthus Pharmaceuticals Inc., a privately-held drug development company, today presented data that Symadex(TM) reverses the clinical and pathological signs of chronic disease in an animal model for multiple sclerosis (MS). The presentation was made by Stephen J. Karlik, PhD, Professor of Diagnostic Radiology at the University of Western Ontario, London, Ontario, together with researchers from Xanthus in aposter session at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Madrid, Spain.

Dr. Karlik used a model of experimental allergic encephalomyelitis(EAE) for the study. This same model was used by Dr. Karlik and his colleagues for published studies with natalizumab and related molecules. The study demonstrated that Symadex can reverse the clinical and pathological signs of chronic disease and that it can permit nerve remyelination. In addition, longer dosing resulted in continued benefit and the pathological changes including inflammation and vascular abnormalities were reversed. Importantly, Symadex did not affect circulating immune cell numbers, suggesting that it is not a general immunosuppressive agent....MORE

2006-11-08T21:36:00.000-08:00

Cannabinoid-Based drug Savitex Appears Helpful for Spasticity in Multiple Sclerosis: Presented at ECTRIMS
Patients with progressive multiple sclerosis showed statistically significant improvement in spasticity-related symptoms following treatment with the cannabinoid-based drug Savitex, researchers reported here at the 22nd Congress of the European Committee for Treatment and research in Multiple Sclerosis (ECTRIMS).

"Since the subjects were able to self titrate the drug, they chose their own regime and there was remarkable concordance in selected dosing, settling at about 7 to 9 sprays per day," said investigator and presenter Christine Collin, MD, honorary professor in cybernetics and neuropsychology, Reading University, and clinician in acute neurorehabilitation and disabling neurological disorders, Reading, United Kingdom.

In the study, presented on September 28th, there was no evidence of dependence, dose escalation, or significant adverse effects, he said.

Dr. Collin and colleagues used the 15-week study to evaluate the efficacy of standardised whole-plant cannabis medicine (Sativex) in patients with MS. They randomised 337 subjects to Sativex or placebo.

Study endpoints included change in mean spasticity Numerical Rating Scale (NRS) score, spasticity NRS at clinic visits, Modified Ashworth Scale, timed 10-meter walk, Barthel Index of activities of daily living, Clinical Global Impression of Change (CGIC), sleep quality, review of pain, tremor and fatigue, spasm severity and bladder symptoms. Effects of treatment on quality-of-life were also measured using the following questionnaires: EuroQual-5 domain (EQ-5D), the Multiple Sclerosis Quality of Life -- 54 domain (MSQoL-54).

Study subjects had exhibited severe levels of spasticity despite ongoing treatment with the best available antispasticity treatments."

For the primary endpoint of mean NRS spasticity, the researchers reported a statistically significant treatment difference of -0.46 points in favour of Sativex in the per protocol (PP) population (P = .035; 95% CI: -0.88, -0.03). The intention to treat (ITT) population achieved a trend in favour of Sativex, with a treatment difference of -0.23 points (P = .219; 95%CI: -0.59, 0.14).

In the PP population, 36% of patients achieved at least a 30% improvement in spasticity NRS with an odds ratio of 1.74 (95% CI: 0.005, 0.266). The researchers observed a trend toward improvement in spasticity NRS in the ITT population, with an odds ratio of 1.34 in favour of Sativex.

"These findings were supported by the CGIC assessment which was strongly in favour of Sativex (odds ratio 1.25, P = .270; 95% CI: 0.84, 1.85)....

2006-11-08T21:35:00.000-08:00

SATIVEX: Cannabis-Based Spray Shows Positive Impact on Overactive Bladder Symptoms of Multiple Sclerosis: Presented at ECTRIMS
"Treatment with cannabis-based Sativex has a positive and sometimes significant impact on the symptoms of overactive bladder in multiple sclerosis (MS) patients, researchers reported here at the 22^nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Sativex is an investigational cannabis-based treatment for pain and symptoms of multiple sclerosis. GW Pharmaceuticals, based in Salisbury, United Kingdom, filed a regulatory submission for the drug in the United Kingdom, Spain, Denmark and the Netherlands for symptomatic relief of spasticity in patient with MS.

"We found both a trend toward improvement in incontinence, the primary endpoint of the study, and statistically significant improvements in a number of related secondary endpoints," said investigator Cris S. Constantinescu, MD, PhD, professor of neurology, University of Nottingham, Nottingham, U.K.

Bladder problems are a common feature of MS, with up to 80% of patients reporting voiding dysfunction, the authors noted in their poster, which was presented on September 29^th.

In their 10-week, double-blind, randomised, placebo-controlled trial, Dr. Constantinescu and colleagues evaluated 135 patients with MS who reported detrusor overactivity who were treated with either Sativex or placebo.

The primary endpoint of the study was reduction number of daily episodes of urgency incontinence. Secondary endpoints included incidence of nocturia and urgency, overall bladder condition measured on an 11-point numerical rating scale, daytime frequency, quality of life, patient's global impression of change (PGIC) and volume voided.

The decrease in incontinence episode frequency per day favoured the Sativex-treated group but was not statistically significant (-1.08, P = .57), the investigators reported.

Results also showed statistical significance in favour of Sativex for 10 of the 11 secondary/tertiary endpoints, with 4 out of 7 secondary endpoints. These included: reduction in nocturia episodes (-0.28, P = .010); highly statistically significant improvement in patients' opinion of bladder symptom severity (-1.16 points, P = .001); reduction in the number of voids per day (-0.85, P = .007) and PGIC scores, where 83.6% of subjects receiving Sativex compared with 58.2% receiving placebo said that the status of their bladder condition had improved (odds ratio 2.56, P = .005).

Findings for number of urgency episodes in Sativex-treated subjects fell just short of statistical significance (-0.76, P = .071).

For tertiary endpoints, the investigators reported that the number of daytime voids was statistically significant in favour of Sativex (-0.57, P = .044). There was also a trend in favour of Savitex for improvement in quality of life but this did not reach statistical significance, the researchers noted.

The study was supported by GW Pharmaceuticals.

[Presentation title: Randomised Controlled Study Of Cannabis-Based Medicine (Sativex) In Patients Suffering From Multiple Sclerosis Associated Detrusor Overactivity. Abstract P411]

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{Abstract: Doctors Guide]

2006-11-08T21:29:00.000-08:00

Pot's Active Ingredient Could Fight Alzheimer's - more at Forbes.com" The active ingredient in marijuana -- delta-9- tetrahydrocannabinol (THC) -- may slow the progression of Alzheimer's disease, new research suggests.

According to a team at the Scripps Research Institute in La Jolla, Calif., THC preserves brain levels of an important neurotransmitter called acetylcholine. It does so by inhibiting the enzyme acetylcholinesterase, which breaks down acetylcholine.

Reporting in the current issue of Molecular Pharmaceutics, the Scripps team noted that existing Alzheimer's medicines, including donepezil and tacrine, also relieve symptoms by inhibiting this enzyme.

In their work in the laboratory, the researchers found that THC inhibits a different site on the acetylcholinesterase molecule and at lower concentrations.

They also discovered that THC prevents the formation of amyloid protein plaques that damage the brain and are a hallmark of Alzheimer's disease.

"Our results provide a mechanism whereby the THC molecule can directly impact Alzheimer's disease pathology," the study authors wrote. In addition, THC may prove valuable as a model for developing new and more effective drugs to treat the disease, they said."

2006-11-08T21:27:00.000-08:00

10 Top Australian Scientists Predict Major Medical Advances in MS, Parkinsons and Diabetes.../Click to download full report
... mean cures for diseases like Parkinson's, Diabetes and Multiple Sclerosis will be entirely possible. With the right prompts these 'stem cells' -- which everybody has ...2006 Australian of the Year, Professor Ian Frazer, who discovered the technology that led to the newly released cervical cancer vaccine, said the upshot will be the ability to develop personalised healthcare plans -- a roadmap for health from the day of birth....You can download the full 'Then, Now...Imagine' Report from http://www.thankyouday.org. From 9 October until 17 November you can also send you personal message of thanks to Australia's health and medical researchers via the website........ {CLICK THE LINK ABOVE)

2006-11-08T21:24:00.000-08:00

MS Injection Anxiety Program: FREE DOWNLOAD FROM THE UNIVERSITY OF CALIFORNIA- SAN FRANCISCO

"....Our research has found that up to 50% of people who are prescribed
medications requiring intramuscular injection are unable to self-inject because of their injection anxiety.

This means that other people must be trained to perform the injection (e.g., a family member), or the person must go to a clinic to obtain the injections.

We found that people who were not able to self-inject due to injection anxiety were much more likely to discontinue taking the medication.

We have therefore developed a brief model of counseling to teach people to
overcome their injection anxiety and learn to self inject. An initial pilot of
our self-injection counseling program showed that it was highly successful
in teaching people to self-inject. We are currently completing a trial of the
intervention that will more definitively test whether or not this program is
effective at teaching self-injection.

Workbook and Manual:

The manual and workbook are copyrighted. We make them available to
patients and counselors free of charge. To read them you will need Adobe
Acrobat Reader. If you need a copy of Acrobat Reader, go to the Adobe
website and follow the instructions to download Acrobat Reader free of
charge.

2006-11-08T21:22:00.000-08:00

Future-directed thinking and depression in relapsing-remitting MS
[Abstract: Br J Health Psychol. 2006 Nov;11(Pt 4):663-75. Royal Holloway, University of London, UK]

BACKGROUND: Research has shown that depression is associated with a view of the future characterized by reduced anticipation of future positive experiences, but not necessarily increased anticipation of future negative experiences. The aim of the present study was to investigate how participants with relapsing-remitting multiple sclerosis (MS) anticipated their future in terms of positive and negative events.

CONCLUSIONS: Like depressed but physically healthy individuals, the MS depressed group was characterized by a lack of positive thoughts about the future, rather than an increased number of negative thoughts. The clinical implications of these findings are discussed along with recommendations for future research.

2006-11-08T21:21:00.000-08:00

Improved walking speed and leg strength in people with MS taking Fampridine-SR [click for more at UK MS Society
Acorda Therapeutics reported positive results following a 14 week phase III clinical trial with a slow release tablet form of 4-aminopyridine (drug name: Fampridine-SR). The drug is thought to improve the conduction of nerve impulses, even if the nerve fibres' insulating coat of myelin has been damaged as a result of MS.

The company reported that 35% of people responded to the treatment, showing an average increase of 25% in their walking speed compared to those on placebo. Another positive outcome was increased leg strength in those on active treatment. People that responded to the drug, also reported feeling "less disabled" in daily activities requiring mobility.

Dr. Lee Dunster, Head of Research at the MS Society said: "We welcome the positive results of an experimental symptomatic therapy that could improve mobility and quality of life in people with different types of MS. We are waiting to see that the new slow-release formulation fulfils safety requirements."

2006-11-08T21:19:00.000-08:00

CAMPATH (alemtuzumab) Editorial by the UK Multiple Sclerosis Society
The (UK) Multiple Sclerosis Society has welcomed the interim results of a phase II trial of Campath (alemtuzumab).

They show that people with MS taking the drug at both high and low doses experienced at least a 75% reduction in the risk of a relapse, compared with those taking Rebif (interferon beta-1a), after more than two years of follow-up. They also experienced at least a 65% reduction in the risk of progression of clinically significant disability.

Simon Gillespie, Chief Executive of the Society, said: ‘These are preliminary but very encouraging results, especially as they demonstrate a significant improvement on currently available therapies. With the appropriate risk management measures in place, we look forward to the completion of this phase of trialling and the important phase III trial.’

The phase II clinical trial was set up to compare the safety and efficacy of Campath (administered intravenously as a course of injections once a year) with Rebif (administered three times per week by subcutaneous injection). 334 people with early active relapsing remitting MS are taking part.

Dosing of Campath in this clinical trial was stopped in September 2005 after three people were diagnosed with immune thrombocytopenic purpura (ITP), a recognised and treatable condition in which low blood platelet counts can lead to abnormal bleeding. An initial case of ITP was fatal. However, five subsequent cases have been successfully treated. Genzyme has since created a comprehensive risk management plan to help physicians and people participating in the trial detect ITP early and minimise the risks of complications.

Other reported side effects of Campath include headache, rash, and fever, temporary worsening of MS symptoms and marginally increased risk of infections. Previous studies have reported around a 30% risk of developing an overactive thyroid, or Graves’ disease, which is a completely treatable condition, but may have serious eye effects in a minority of people. However, Genzyme reports that incidents of all thyroid-related adverse events, including Graves’ disease, were less than expected.

Genzyme is expected to initiate a phase III clinical trial with Campath early in 2007.

What is Campath?

Campath® (alemtuzumab) is a humanized monoclonal antibody, that is licensed for the treatment of chronic lymphatic leukaemia. It is thought to have an anti-inflammatory effect in MS. It binds to a specific target on the surface of immune cells and then depletes these cells. Campath has a prolonged action and therefore administration of one dose a year (or even after a longer interval) may be sufficient.

2006-11-08T21:18:00.000-08:00

CAMPATH: "It very well shut down their disease. The reduction in relapses was amazing"
"....Jose Mezquita, 32, awoke one morning, and had difficulty walking. "It started last August. I had numbness in the legs, and basically that was about it at the time,” he said.

Mezquita was diagnosed with MS. The available treatment options, he discovered, could only slow its progression.

That's when he heard about a clinical trial using a drug called Campath. Dr. Brian Steingo, a neurologist and one of the investigators, says in preliminary studies, Campath has shown promise.

"It very well shut down their disease. The reduction in relapses was amazing, so I am very excited about it,” said Dr. Steingo.

In multiple sclerosis, some of the body's own white blood cells behave abnormally, and attack the fatty sheath around nerves in the brain and spinal cord. Campath is made up of antibodies designed to help the immune system remove those white blood cells.

"The idea of the antibody is to essentially wipe out the white blood cell to significantly repair its function,” said Dr. Steingo.

....Campath is already approved by the FDA to treat a certain form of leukemia, but the focus of this trial is to see if it can slow multiple sclerosis, or better yet, stop it in its tracks.

2006-11-08T21:15:00.000-08:00

Self-generated learning in people with MS...MORE:
[Abstract: Pub Med][Department of Psychology, University of Tulsa, Tulsa, Oklahoma]
"Memory impairment is among the most common cognitive deficits in people with multiple sclerosis (MS). To remediate this problem, recent research has evaluated the benefits of self-generated encoding. These nascent investigations reveal that people with MS who have mild memory impairment demonstrate a significant memory benefit from self-generated encoding compared with didactic learning.....In agreement with and extending prior research, MS patients remembered more information if it was self-generated rather than didactically presented, and this finding occurred despite moderate-severe memory impairment. Furthermore, compared with didactic encoding, self-generation enhanced recall of activities of daily living. Implications of these findings for cognitive rehabilitation and the nature of memory impairment in MS are discussed."

2006-11-08T21:11:00.000-08:00

CDP323: NEW DRUG IN PIPELINE...UCB and Biogen Idec to Collaborate on MS Therapy: UBC Press Release

UCB, Brussels, Belgium, and Biogen Idec, Cambridge, Mass., announced a global collaboration to jointly develop and commercialize CDP323, an orally active small molecule alpha4-integrin inhibitor expected to enter phase II clinical trials next year, to treat relapsing-remitting multiple sclerosis.

UCB (Euronext Brussels: UCB) and Biogen Idec (NASDAQ: BIIB) today announced a global collaboration to jointly develop and commercialize CDP323 for the treatment of relapsing-remitting multiple sclerosis (MS) and other potential indications. CDP323 is an orally active small molecule alpha4-integrin inhibitor expected to enter Phase II clinical trials next year.

Under terms of the agreement, UCB will receive upfront and additional payments for development and commercial milestones in excess of 200 million US dollars. Furthermore Biogen Idec will contribute significantly to clinical costs for Phase II and Phase III studies. All commercialization costs and profits will be shared equally.

"Multiple Sclerosis affects more than a million people worldwide and we are delighted to be collaborating with Biogen Idec on our exciting CDP323 program. CDP323 has arisen from UCB's in-depth understanding of integrin biology and chemistry to address this difficult protein target. Our outstanding Phase I results encourage us to move rapidly into Phase II trials in MS patients. We believe that if trials are successful CDP323 could make a real difference for MS patients with this severe and debilitating disease," stated Melanie Lee, Executive Vice President, Research & Development for UCB.

“We are always looking to enhance and expand our arsenal in the fight against MS,” said Al Sandrock, Senior Vice President, Neurology Research and Development for Biogen Idec. “Another effective oral therapy would augment Biogen Idec's broad portfolio of products and potential therapies in development for this debilitating disease. We are pleased that UCB has decided to partner with us on such a promising program.”

About CDP323
CDP323 is a potent and orally active small molecule prodrug antagonist of alpha4-integrins. The safety, tolerability and pharmacokinetic profile of CDP323 have been evaluated in healthy volunteers in three separate Phase I studies. CDP323 was well tolerated with an adverse event profile comparable to placebo. Data from these studies have been reported at the 2006 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). FULL RESS RELEASE

2006-11-08T21:09:00.001-08:00

"MS patients set to trial cannabis pill": UK
Patients from across Norfolk are to take part in a national study to test whether cannabis extract can help to slow the progress of multiple sclerosis.

The trial will involve 20 patients from the Norfolk and Norwich University Hospital who will take the extract in pill form and be closely monitored over a three-and-half-year period.

Two-thirds of the patients will receive the drug, while the remaining third will be given a placebo.”...FULL STORY

2006-11-08T21:09:00.000-08:00

Methylthioadenosine Effective in Animal Models of MS
Methylthioadenosine (MTA), an adenine nucleoside produced from S-adenosylmethionine, is effective in animal models of acute and chronic multiple sclerosis (MS), according to a report in the September issue of the Annals of Neurology.

"A cell compound such as methylthioadenosine is able to modulate the immune response, and it might become a useful therapy for autoimmune diseases with less toxicity than other drugs because the cell has several mechanisms to compensate its excess," Dr. Pablo Villoslada told Reuters Health.

Dr. Villoslada and colleagues from the University of Navarra, Spain studied the effects of intraperitoneal MTA in rodent experimental autoimmune encephalomyelitis (EAE, a model of MS) and in peripheral blood mononuclear cells from multiple sclerosis patients and healthy controls.full story - Ann Neurol 2006;60:323-334.

2006-11-08T21:08:00.000-08:00

After nighttime treatment, clinical recovery was significantly enhanced and the mean number of side effects was significantly lower. -- Journal of Neurology, Neurosurgery, and Psychiatry
Background: The activity of the immune system displays a circadian rhythm. In diseases characterized by aberrant immune activity, chronotherapy - treatment regimen tailored to diurnal body rhythms - may increase medication efficiency, safety, and tolerability.

The goal of this study was to compare the outcomes of intravenous corticosteroid administration during the day or night, for treatment of acute multiple sclerosis (MS) relapses.

Methods: Seventeen MS patients were included in the study. Clinical assessment of disability was performed at trial entry, and at days 7 and 30 from therapy initiation. Adverse events and preference of nighttime versus daytime therapy were assessed at the end of the treatment course.

Results: After nighttime treatment, clinical recovery was significantly enhanced and the mean number of side effects was significantly lower. Furthermore, the majority of patients expressed a preference for nighttime versus daytime treatment.....

CLICK FOR MORE OF THIS ABSTRACT

2006-11-08T21:07:00.000-08:00

Testosterone gel may help men with MS
Jeffrey Steenberg loves the outdoors, but when doctors diagnosed him with multiple sclerosis four years ago, even the simple tasks became exhausting.

"Just finding myself extremely tired a lot. I couldn't make it through a day without napping," he said.

About half of all MS patients also have memory problems.

"I definitely noticed some of the memory going. Calling somebody immediately after calling them and not knowing who was on the phone anymore," he said.

Neurologist Rhonda Voskuhl says there's no approved treatment to prevent memory failure.

"What we don't have are drugs that would be going to the brain or spinal cord and protecting those nerves," she said.

A testosterone gel might help. In a small study, 10 men with MS applied it to their shoulders once a day for a year.

"What they reported most is that they felt better, that they had more energy and less fatigue," said Voskuhl.

The gel improved their immune systems and all the patients performed better on memory tests. MRI scans also showed parts of the brain that normally decline in MS actually slowed.

"We're excited about these findings because we're actually would be describing the first neural protective drugs for MS," said Voskuhl.

Steenberg noticed a difference.

"The increased energy and mental alertness were the biggest, the biggest changes for me," he said.

Researchers are expected to study whether estrogen provides the same memory benefits in female patients.

2006-11-08T21:05:00.000-08:00

BILL GATES BEHIND POTENTIAL MS DRUGS IN PIPELINE:

"The $2.1 billion acquisition of Icos Corp. is interesting on many levels."

"The company's largest investor is Bill Gates, the billionaire founder and chairman of Microsoft Corp. Gates holds 10 percent of Icos' equity."

......Icos already has hired 23 Ph.D.s to search for new treatments for rheumatoid arthritis, multiple sclerosis, asthma and other inflammatory diseases."

About 40 employees, including research teams, have already been hired. The company plans to start operations with 65, he said. Researchers have been recruited from across the country, he said, including the University of Washington and the Fred Hutchinson Cancer Research Center.

The company is focusing on finding a ''new generation of biopharmaceutical products for some of the most intractable human diseases,'' including rheumatoid arthritis, multiple sclerosis and asthma, Nowinski said.

Competitors have mainly tried to treat the symptoms of the so-called inflammatory diseases, he said. ''There's a very large market there, but it doesn't really address the underlying problems.''

Icos plans to develop biological and pharmaceutical products that will arrest disease in the early stages, he said.
CLICK FOR FULL ARTICLE

2006-11-08T21:02:00.001-08:00

Biogen Idec reported positive Phase II data from its product BG-12, which could potentially become the first oral therapy for the treatment of multiple sclerosis. ...."Genentech also announced positive top-line Phase II data from its product Rituxan in multiple sclerosis (MS), suggesting the drug could play a prominent role in future MS-therapy. Rituxan is already a multi-billion dollar product approved for the treatment of Non-Hodgkins lymphoma and rheumatoid arthritis."

2006-11-08T21:02:00.000-08:00

NEW DRUG IN PIPELINE: MBP8298: ...BioMS Medical Press Release
Mr. Kevin Giese, President and CEO, will present at the MS Society of Canada, Alberta Division's Annual General Meeting in Calgary, Alberta.
WHEN: Saturday, November 4th at 1:10 pm (Mountain Time) WHERE: Greenwood Inn, Calgary, Alberta

About The MS Society of Canada - Alberta Division Founded in 1980, the Alberta Division office is located in Edmonton, Alberta. The mission of the Multiple Sclerosis Society of Canada is: To be a leader in finding a cure for multiple sclerosis and enabling people affected by MS to enhance their quality of life. For more information visit www.mssociety.ca

BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is currently in a pivotal Phase II/III clinical trial across Canada and Europe. Click Here For further information on BioMS: NEW DRUG IN PIPELINE: MBP8298

2006-11-08T21:01:00.000-08:00

Multiple sclerosis treatment: Is combination therapy effective? - MayoClinic.com
Combination therapy most often refers to the use of two or more medications to treat a single disease. Scientists are studying the potential benefits of combination drug therapy in multiple sclerosis treatment.

Interferon beta-1a (Avonex, Rebif) and glatiramer (Copaxone) are two drugs approved by the Food and Drug Administration for the treatment of relapsing remitting multiple sclerosis (MS). Each drug has a different mechanism of action and is generally considered to provide mild to moderate benefit in reducing MS symptoms.

But the question has been raised as to whether these two drugs used in combination may provider a greater benefit than either drug used alone. To answer this question, a large, randomized, double-blind, multicenter study is underway. The study — which is looking at the safety as well as at the effectiveness of this combination — began in 2005, and results are expected in late 2009.

Until these results are available, it is unclear what role, if any, combination drug therapy may play in routine multiple sclerosis treatment.

2006-11-08T21:00:00.000-08:00

Marinol - Cannabinoid Activator Mellows Out Colon - CME Teaching Brief - MedPage Today
Drugs that activate cannabinoid receptors in the colon might help treat lower GI conditions such as diarrhea or certain types of fecal incontinence, according to a proof-of-concept study presented here.
Action Points

* Advise patients that larger clinical trials would be necessary before cannabinoid activators could be used widely for conditions of the lower colon.

* This report is based on an abstract presented at a meeting. These data and conclusions should be considered preliminary as they have not yet been reviewed and published in a peer-reviewed publication.

The study found that Marinol (dronabinol) significantly relaxed the colon in healthy volunteers who had consumed a 1,000-calorie chocolate milkshake, reported Tuba Esfandyari, M.D., of the Mayo Clinic in Rochester, Minn., at the American College of Gastroenterology meeting here.

The study is the first to demonstrate that the drug, a synthetic version of the natural compound delta-9-THC found in the marijuana plant, may also have beneficial effects in the lower colon, said co-author Michael Camilleri, M.D., also of the Mayo Clinic. Marinol is approved to treat nausea, vomiting, and lack of appetite during chemotherapy.

In the double-blind, parallel-group study, 52 volunteers were randomly assigned to a single dose of 7.5 mg of Marinol or placebo. Thirty of the volunteers were women and 22 were men. Their average age was about 35.

Before taking Marinol, baseline measurements of colonic contraction and sensation were taken. These measurements were repeated one hour after taking the medication. Finally, the measurements were taken once again an hour after participants drank the milkshake.

Compared with placebo, the drug was associated with significant inhibition of postprandial colonic contractions (P=0.048) as well as a non-significant effect on fasting colonic contractions (P=0.096), the researchers reported.

The effect on colonic contraction was more pronounced in women than men, the researchers said, although data on the gender difference was not reported.

The drug also had an overall significant relaxing effect on the colon (P=0.045), the study found.

The drug did not appear to have a significant effect on participants' feelings of abdominal pain or discomfort after ingesting the milkshake, the study authors reported.

Nevertheless, the results suggest that "the potential for cannabinoids to modulate colonic motor function in disease deserves further study," the investigators concluded.

More specifically, the drug's ability to inhibit colonic contraction after a meal might help treat certain types of fecal incontinence that are not based on abnormal sphincter function but on unusually strong colonic contractions, Dr. Camilleri said.

The drug, or others like it, might also be useful for treating the diarrhea associated with irritable bowel syndrome, he said.

Marinol is a non-selective cannabinoid activator, but the study suggests selective cannabinoid activators might have the same effects on the colon, Dr. Camilleri said.

Selective cannabinoid activators would likely not have the psychoactive side effects associated with Marinol or other non-selective cannabinoid activators. However, Marinol was the only drug available for study in humans, Dr. Camilleri said.

Marinol is made by Slovay Pharmaceuticals of Marietta, Ga. MORE

2006-11-08T20:55:00.000-08:00

"MS forum hears of pot's benefits":

The Winnipeg Free Press
Marijuana, the illegal street drug that can get you arrested and jailed, remains a medicine people with MS hate to admit they use.

Cannabis -- the formal name for marijuana -- along with various other medicinal herbs and nutritional supplements like vitamins K, D, B-12 and omega-three fish oils, are attracting patients nevertheless, Ceaser said.

The Charleswood health practitioner cited THC, the active ingredient in cannabis, as a nerve-affecting element that soothes spasms, eases pain and promotes sleep. Doctors can help patients get federal approval to use it.

Conference spokeswoman Gwenda Nemerofsky confirmed there are people in Manitoba who have applied to Health Canada for legal permits to use marijuana as medicine.

"But most will not come forward," she said.

Some take it by prescription in forms like nasal spray. Others roll it up in cigarette papers and smoke it. Some even grow it.

The conference focused on the social and emotional devastation that can accompany a diagnosis of MS and ways, including pot, that patients can cope better....

Dr. Michael Schapiro, an expert in MS from the Minneapolis Clinic for Neurology, said his mother had the disease, so he understands how hard it is for patients and their families to live with it.

But the American doctor is not keen on marijuana as a solution, especially if it's smoked.

Studies show smoking pot can block symptoms like muscle tremors, the doctor said. And prolonged toking can kill off brain cells in the same way alcohol abuse does. It can also cause respiratory diseases, like tobacco-smoking does.

"It's not just a casual thing," Schapiro said.more

2006-11-08T20:41:00.000-08:00

TOVAXIN: Opexa Begins Dosing Patients in Phase IIb Trial of Tovaxin for MS
"Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company involved in the development and commercialization of cell therapies, announced today that it has dosed the first patient in its 150-patient Phase IIb clinical trial of Tovaxin™ in multiple sclerosis. Enrollment is expected to be completed by mid-2007. There are currently 31 trial sites in the U.S., all of which are actively recruiting patients; the first patient was treated by Dr. Suzanne Gazda, Principal Investigator at Integra Clinical Research in San Antonio, Texas.

As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate.

All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

David McWilliams, president and chief executive officer of Opexa, commented, “We have received a very enthusiastic More on Opexa Therapeutics Home Page

2006-11-08T20:38:00.000-08:00

cladribine...FDA also approves fast-track testing of drug for MS treatment....BYU News Release
Brigham Young University researchers have developed an improved method for making a drug called "" that has proven effective against certain types of cancer, including hairy cell leukemia, which affects as many as 800 patients a year.

In related news, pharmaceutical company Serono recently received "fast-track" status by the Food and Drug Administration for testing its new oral cladribine treatment for multiple sclerosis, which affects 2 million people worldwide.

Morris J. Robins, the J. Rex Goates Professor of Chemistry, led BYU's efforts to devise the more effective way of synthesizing cladribine.

Joined by graduate student Minghong Zhong and postdoctoral fellow Ireneusz Nowak, Robins published his laboratory's improved method this fall in The Journal of Organic Chemistry.

"It's very gratifying to know that something we do in the laboratory may be used to improve the condition of others," said Robins, whose past research and discoveries have contributed to the fight against AIDS and hepatitis B.

Arthur D. Broom, professor of medicinal chemistry and associate dean for research at the University of Utah's College of Pharmacy, said that Robins is one of the world leaders in the area of nucleoside chemistry. Nucleosides are the building blocks of DNA and RNA, which carry a person's genetic information.

"A problem with cladribine and many similar drugs is that they are very difficult and expensive to make, largely because the chemical syntheses involved result in the formation not of just the desired drug, but several related, but useless, chemical compounds," said Broom.

"Dr. Robins has found a novel, relatively inexpensive and highly specific way to eliminate the formation of these unwanted byproducts, giving the pure cladribine as the sole compound," added Broom. "This is a very significant advance in making important drugs available at reasonable cost."

BYU's new patent-pending method may be of interest to pharmaceutical companies that produce cladribine.

"A good method to synthesize cladribine is important for industries that produce this compound, and even more important to the patients that need the drug for treatment," said Herdewijn. "Dr. Robins' methodology has no precedent in the field and brings the technology near to perfection."

2006-10-16T07:07:00.000-07:00

DR. TIMOTHY VOLLMER HAS WRITTEN AN ARTICLE FOR US ON THE 4 TREATMENTS HE FEELS ARE MOST PROMISING...OUT OF ALL OF THE NEW MS TREATMENTS THAT WERE ANNOUNCED AT ECTRIMS: The 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis...September 27–30 in Madrid, Spain

Click here if you haven't requested our weekly MS Drug Alerts

HERE'S 27 NEW MS TREATMENTS WE'VE POSTED IN THE LAST 2 WEEKS:

SCROLL DOWN..BELOW THIS POST..FOR THE FULL STORY ON EACH HEADLINE:

1...TYSABRI HELPS COGNITION: Tysabri reduced the risk of sustained cognitive worsening by 43 percent, compared to placebo.....

2...CAMPATH: "Genzyme Says MS Drug Works Better Than Serono's Rebif"

3...ORAL FINGOLIMOD - FTY720: Presented at ECTRIMS
Oral FTY720 (Fingolimod) for Relapsing Multiple Sclerosis Shows Sustained Benefits for Up to 2 Years

4....NEW REBIF AUTO-INJECTOR: ECTRIMS Presentation on new-improved Rebif PLUS It's new auto-injector, which uses the thinnest needle of any treatment!!!
New Formulation Rebif for Relapsing Multiple Sclerosis Lowers Immunogenicity and Improves Tolerability

5...ORAL LAQUINIMODE BY TEVA: The NEW once-daily novel oral agent for relapsing remitting

6...ORAL FAMPRIDINE-SR BY SERONO: FDA fast-tracks Serono's oral MS drug Cladribine...
Patients who took Fampridine-SR moved 25 percent faster ontimed 25-foot walk, while patients getting a placebo improved 4.7 percent, Hawthorne

7...COPAXONE(R) Showed Sustained Benefit on Slowing Brain Tissue Damage in Multiple Sclerosis Patients
Data presented last week at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

8...FATIGUE AND FUNCTIONAL DEFICIT IMPROVEMENT: Four-week Rehab Significantly Improves Fatigue and Functional Deficit in Multiple Sclerosis Patients: Presented at ECTRIMS
Fatigue and functional deficits in multiple sclerosis (MS) patients were significantly improved during 4 weeks of inpatient rehabilitation, researchers reported here at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)....

9...SATIVEX - CANNABINOID-BASED DRUG: Savitex Appears Helpful for Spasticity in Multiple Sclerosis: Presented at ECTRIMS

10...MBP8298: New Drug in the Pipeline...A message from Ryan Giese

11...CDP323: NEW DRUG IN PIPELINE - Biogen Idec:
"Biogen Idec and UCB and to collaborate on oral multiple sclerosis therapy U.C.B. and BIIB announce a global collaboration to jointly develop and commercialize CDP323 for the treatment of relapsing-remitting multiple sclerosis...

12...PPMS: Small Study Holds Hope For chronic progressive patients with MS [PPMS]

13...COPAXONE New Data Confirmed Antibodies to Copaxone® Do Not Impact Its Established and Sustained Long-Term Efficacy in Multiple Sclerosis

14...COPAXONE WITH MITOXANTRONE: Very Active Multiple Sclerosis Patients Benefited From COPAXONE(R) Treatment Following Short-Term Induction With Mitoxantrone

15...AVONEX PRESS RELEASE FROM ECTRIMS
....treatment with AVONEX (Interferon beta-1a) promoted a statistically significant recovery of T1-black hole lesion volume by almost 24%....

16...LYRICA: Pfizer's Lyrica(Pregabalin Capsules) Approved in Europe for Difficult-to-Treat Nerve Pain.

17...MBP8298 shown to safely delay disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. BioMS Medical to present at the 22nd Congress of the European Com mittee for Treatment and Research in Multiple Sclerosis (ECTRIMS) :

18..."Testosterone gel proven to slow symptoms of MS...in small study": UCLA School of Medicine,

19...TYSABRI - Presented at ECTRIMS
Natalizumab (Tysabri) Reduces Brain Atrophy, Improves Cognition During Second Year of Multiple Sclerosis Treatment

20...TOVAXIN: New drug in the pipeline

21...REBIF: NEW FORMULATION: ONE-YEAR DATA FROM PHASE III TRIAL SHOW THAT NEW FORMULATION OF REBIF® OFFERS SUBSTANTIAL IMPROVEMENT IN TOLERABILITY AND IMMUNOGENICITY PROFILES...[click for full press release]:

22...NovaDel Announces Two CNS Oral Spray Drug Candidates in its Development Pipeline; Oral Spray Formulations of Tizanidine for Spasticity

23...SYMADEX...NEW DRUG ANNOUNCEMENT FROM ECTRIMS
Symadex Can Reverse Disease in Preclinical Multiple Sclerosis Animal Model

24...NICOTINAMIDE: "Daily Nicotinamide Shots May Protect MS Patients From Severe Disability"

25...Gene found that helps combat MS [MORE: BBC NEWS]
A gene that helps to stave off the effects of multiple sclerosis (MS) has been discovered by scientists. A Danish-UK team found that a known risk gene for MS, called DR2b, is always partnered by a twin gene - DR2a....

26...Novantrone (mitoxantrone)... Safety and Tolerability of Mitoxantrone for Worsening Multiple Sclerosis Appears Stable in Long Term: Presented at ECTRIMS...

27...Age Should Not Deter Multiple Sclerosis Diagnosis: Presented at ECTRIMS

SCROLL DOWN FOR THE STORIES BEHIND THE 27 HEADLINES ABOVE

Click here if you haven't requested our weekly Drug Alerts

2006-10-14T11:39:00.000-07:00

Symadex Can Reverse Disease in Preclinical Multiple Sclerosis Animal Model

"Xanthus Pharmaceuticals Inc., a privately-held drug development company, today presented data that Symadex(TM) reverses the clinical and pathological signs of chronic disease in an animal model for multiple sclerosis (MS). The presentation was made by Stephen J. Karlik, PhD, Professor of Diagnostic Radiology at the University of Western Ontario, London, Ontario, together with researchers from Xanthus in aposter session at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Madrid, Spain.

Dr. Karlik used a model of experimental allergic encephalomyelitis(EAE) for the study. This same model was used by Dr. Karlik and his colleagues for published studies with natalizumab and related molecules. The study demonstrated that Symadex can reverse the clinical and pathological signs of chronic disease and that it can permit nerve remyelination. In addition, longer dosing resulted in continued benefit and the pathological changes including inflammation and vascular abnormalities were reversed. Importantly, Symadex did not affect circulating immune cell numbers, suggesting that it is not a general immunosuppressive agent....MORE

2006-10-14T11:38:00.000-07:00

Oral FTY720 (Fingolimod) for Relapsing Multiple Sclerosis Shows Sustained Benefits for Up to 2 Years

MADRID, SPAIN -- September 30, 2006 -- The investigative oral agent FTY720 (fingolimod) shows sustained clinical benefits for up to 2 years for patients with relapsing-remitting multiple sclerosis (RRMS), according to data from an extension of a phase 2 study presented here at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

"Notably, the relapse reduction rate of 50% and the inflammatory disease reduction rate of 80% that we saw at 6 months was sustained in this extension study," said lead investigator and presenter Ludwig Kappos, MD, head, Neurology-Neurosurgery Outpatients Clinics, University Hospital, Basel, Switzerland.

The objective of the extension study was to report safety and efficacy results during 24 months of follow-up, the authors said.....

"These positive results support further evaluation of fingolimod as an oral treatment option in the ongoing phase III program in RRMS," they wrote.....

"It appears that FTY720 might not only offer significant clinical benefits to patients but, as an oral agent, it could also serve to enhance compliance," Dr. Kappos said. "Large-scale, international phase 3 studies of the use of the drug in relapsing-remitting MS are now underway," he added.....
[Presentation title: Oral Fingolimod (FTY720) in Relapsing Multiple Sclerosis: 24-Month Results of the Phase II Study. Abstract P376]

2006-10-09T07:46:00.001-07:00

SATIVEX: Cannabis-Based Spray Shows Positive Impact on Overactive Bladder Symptoms of Multiple Sclerosis: Presented at ECTRIMS
"MADRID, SPAIN -- October 3, 2006 -- Treatment with cannabis-based Sativex has a positive and sometimes significant impact on the symptoms of overactive bladder in multiple sclerosis (MS) patients, researchers reported here at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)...."
{Abstract: Doctors Guide]

2006-10-09T07:46:00.000-07:00

Cannabinoid-Based drug Savitex Appears Helpful for Spasticity in Multiple Sclerosis: Presented at ECTRIMS
MADRID, SPAIN -- October 3, 2006 -- Patients with progressive multiple sclerosis showed statistically significant improvement in spasticity-related symptoms following treatment with the cannabinoid-based drug Savitex, researchers reported here at the 22nd Congress of the European Committee for Treatment and research in Multiple Sclerosis (ECTRIMS).

"Since the subjects were able to self titrate the drug, they chose their own regime and there was remarkable concordance in selected dosing, settling at about 7 to 9 sprays per day," said investigator and presenter Christine Collin, MD, honorary professor in cybernetics and neuropsychology, Reading University, and clinician in acute neurorehabilitation and disabling neurological disorders, Reading, United Kingdom.

In the study, presented on September 28th, there was no evidence of dependence, dose escalation, or significant adverse effects, he said.

Dr. Collin and colleagues used the 15-week study to evaluate the efficacy of standardised whole-plant cannabis medicine (Sativex) in patients with MS. They randomised 337 subjects to Sativex or placebo.

Study endpoints included change in mean spasticity Numerical Rating Scale (NRS) score, spasticity NRS at clinic visits, Modified Ashworth Scale, timed 10-meter walk, Barthel Index of activities of daily living, Clinical Global Impression of Change (CGIC), sleep quality, review of pain, tremor and fatigue, spasm severity and bladder symptoms. Effects of treatment on quality-of-life were also measured using the following questionnaires: EuroQual-5 domain (EQ-5D), the Multiple Sclerosis Quality of Life -- 54 domain (MSQoL-54).

Study subjects had exhibited severe levels of spasticity despite ongoing treatment with the best available antispasticity treatments."

For the primary endpoint of mean NRS spasticity, the researchers reported a statistically significant treatment difference of -0.46 points in favour of Sativex in the per protocol (PP) population (P = .035; 95% CI: -0.88, -0.03). The intention to treat (ITT) population achieved a trend in favour of Sativex, with a treatment difference of -0.23 points (P = .219; 95%CI: -0.59, 0.14).

In the PP population, 36% of patients achieved at least a 30% improvement in spasticity NRS with an odds ratio of 1.74 (95% CI: 0.005, 0.266). The researchers observed a trend toward improvement in spasticity NRS in the ITT population, with an odds ratio of 1.34 in favour of Sativex.

"These findings were supported by the CGIC assessment which was strongly in favour of Sativex (odds ratio 1.25, P = .270; 95% CI: 0.84, 1.85)....

2006-10-09T07:45:00.000-07:00

Small Study Holds Hope For chronic progressive patients with MS [PPMS]
(Efficacy of mitoxantrone and intrathecal triamcinolone acetonide treatment in chronic progressive multiple sclerosis patients: Clin Neuropharmacol. 2006 Sep-Oct;29(5):286-91.)
ABSTRACT: Treatment approaches are rare for chronic progressive patients with multiple sclerosis (MS). Objective was to evaluate the clinical benefit of repeated intrathecal application of the sustained release steroid triamcinolone acetonide or the administration of mitoxantrone (MIX)

Both treatment regimens were safe; the patients experienced nearly no adverse effects. Triamcinolone acetonide application provided a clinical benefit, whereas MIX administration prevented further worsening of MS symptoms. We stress that only specialists with a broad experience in intraspinal triamcinolone acetonide application and MIX administration should perform both kinds of therapy only after a careful information and risk-benefit evaluation in cooperation with the patient. Future trials will show the efficacy of combination of both treatment approaches in chronic progressive patients with MS....

2006-10-09T07:43:00.000-07:00

CDP323: NEW DRUG IN PIPELINE - Biogen Idec:
"Biogen Idec and UCB and to collaborate on oral multiple sclerosis therapy U.C.B. and BIIB announce a global collaboration to jointly develop and commercialize CDP323 for the treatment of relapsing-remitting multiple sclerosis and other potential indications.Under terms of the agreement, U.C.B will receive upfront and additional payments for development and commercial milestones in excess of 200 million US dollars. Furthermore BIIB will contribute significantly to clinical costs for Phase II and Phase III studies."

2006-10-09T07:42:00.000-07:00

Four-week Rehab Significantly Improves Fatigue and Functional Deficit in Multiple Sclerosis Patients: Presented at ECTRIMS
Fatigue and functional deficits in multiple sclerosis (MS) patients were significantly improved during 4 weeks of inpatient rehabilitation, researchers reported here at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

"Inpatient rehab works in MS patients, and we have seen in this study in detail that it works, especially ameliorating fatigue, function of upper limbs and cognition, " said lead investigator Stephan Bamborschke, MD, professor of neurology, Charité Hospital, Berlin, and head of rehabilitation, Brandenburg Clinic, Bernau, Germany, who presented the findings on September 28th.

The purpose of the study was to assess the efficacy of neurological rehabilitation in MS patients, using the Multiple Sclerosis Functional Composite (MSFC, Cutter 1999) scale and measuring fatigue using the Fatigue Severity Scale (FSS, Krupp 1989), given to patients before and after rehabilitation.

"We also looked for parameters which possibly could predict the improvement of fatigue," the research team wrote in their poster presentation....
[Presentation title: Efficacy of Neurological Inpatient Rehabilitation Measured By Fatigue Severity Scale and Multiple Sclerosis Functional Composite in Multiple Sclerosis Patients. Abstract P431]

2006-10-09T07:41:00.000-07:00

Safety and Tolerability of Mitoxantrone for Worsening Multiple Sclerosis Appears Stable in Long Term: Presented at ECTRIMSMADRID, SPAIN -- October 2, 2006 -- Researchers report that the safety and tolerability of Novantrone (mitoxantrone) in long-term treatment of worsening multiple sclerosis appears to be consistent with its known safety profile.

The findings were presented here on September 29th at the 22nd Congress of the European Committee for Treatment and research in Multiple Sclerosis (ECTRIMS).

"In a large sample of patients followed prospectively, we found that the risk/benefit ratio is in keeping with prior knowledge about this drug," said lead investigator Edward Fox, MD, PhD, clinical assistant professor, University of Texas Medical Branch, Austin, Texas.

Mitoxantrone is currently being evaluated for long-term safety and tolerability in patients with worsening relapsing-remitting multiple sclerosis, progressive relapsing multiple sclerosis and secondary progressive multiple sclerosis in the ongoing, multicenter, open-label Registry to Evaluate Novantrone Effects in Worsening MS (RENEW).....

2006-10-09T07:38:00.000-07:00

Oral FTY720 (Fingolimod) for Relapsing Multiple Sclerosis Shows Sustained Benefits for Up to 2 Years
MADRID, SPAIN -- September 30, 2006 -- The investigative oral agent FTY720 (fingolimod) shows sustained clinical benefits for up to 2 years for patients with relapsing-remitting multiple sclerosis (RRMS), according to data from an extension of a phase 2 study presented here at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

"Notably, the relapse reduction rate of 50% and the inflammatory disease reduction rate of 80% that we saw at 6 months was sustained in this extension study," said lead investigator and presenter Ludwig Kappos, MD, head, Neurology-Neurosurgery Outpatients Clinics, University Hospital, Basel, Switzerland.

The objective of the extension study was to report safety and efficacy results during 24 months of follow-up, the authors said.....

"These positive results support further evaluation of fingolimod as an oral treatment option in the ongoing phase III program in RRMS," they wrote.....

"It appears that FTY720 might not only offer significant clinical benefits to patients but, as an oral agent, it could also serve to enhance compliance," Dr. Kappos said. "Large-scale, international phase 3 studies of the use of the drug in relapsing-remitting MS are now underway," he added.....
[Presentation title: Oral Fingolimod (FTY720) in Relapsing Multiple Sclerosis: 24-Month Results of the Phase II Study. Abstract P376]

2006-10-09T07:35:00.000-07:00

2006-10-09T07:28:00.001-07:00

"Testosterone gel proven to slow symptoms of MS...in small study"....]CLICK TO READ MORE:
"In a small study, 10 men with multiple sclerosis applied this testosterone gel to their shoulders once a day for a year; the study found the gel improved their immune systems and all the patients performed better on memory tests....

Rhonda Voskuhl, M.D., of the UCLA School of Medicine, says, "What they reported is that they felt better, that they had more energy and less fatigue."

The gel improved their immune systems and all the patients performed better on memory tests.

MRI scans also showed parts of the brain, which normally decline when affected by multiple sclerosis, actually slowed."...

2006-10-09T07:28:00.000-07:00

MBP8298 shown to safely delay disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. BioMS Medical to present at the 22nd Congress of the European Com mittee for Treatment and Research in Multiple Sclerosis (ECTRIMS) :
"MBP8298 shown to safely delay disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. Phase II and long-term follow-up treatment data to be presented at ECTRIMS - MBP8298 shown to safely delay disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. - Pivotal Phase II/III clinical trial underway in Europe and Canada - .....MORE"

2006-10-09T07:27:00.000-07:00

Oral cladribine: FDA fast-tracks Serono's oral MS drug - "The Serono Biotech Center is seen in Corsier-sur-Vevey, Switzerland - FULL ARTICLE:

"...Fast-track programs are designed to facilitate the development and expedite the review of new drugs that could treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Oral cladribine is now eligible for priority review, and the FDA can review data as it is received, instead of waiting until Serono's new drug application is completed...."

2006-10-09T07:26:00.002-07:00

New Drug helps some MS victims walk betterScientists at Acorda Therapeutics, in Hawthorne, N.Y., announced their results Monday after finishing analysis of the study over the weekend. Patients on the medicine were walking consistently faster over a 14-week period than those on a placebo. Their leg muscles also seemed stronger.

"This is a great drug and a great story," said Dr. Lauren Krupp, director of the pediatric MS center at Stony Brook University Hospital and co-director of the adult center. She treated 16 of her patients with Acorda's experimental drug. "We had great results," she said. "Our goal is to keep patients out of a wheelchair." Multiple sclerosis is an autoimmune disease that affects the central nervous system.

Krupp said she first heard about the substance, now called Fampridine-SR, more than 20 years ago. The chemical was synthesized from coal tar in the 1890s. It took almost 100 years for scientists to discover its biological properties. It improves impulse conduction along nerve fibers....

2006-10-09T07:26:00.000-07:00

>PRESS RELEASE BY TEVA: LAQUINIMOD -The once-daily novel oral agent for relapsing remitting MS..READ FULL ARTICLE

"Laquinimod Phase IIb Trial confirms efficacy and favorable safety profile and shows significant reduction in the rate of inflammatory disease activity

The once-daily novel oral agent for relapsing remitting multiple sclerosis (MS) patients met its primary end-point."

"Jerusalem, Israel and Lund, Sweden, September 5, 2006 - Teva Pharmaceutical Industries Ltd (Nasdaq: TEVA) and Active Biotech AB (ACTI.ST) today announced that a Phase IIb study designed to evaluate the safety and efficacy of laquinimod, a once-daily novel oral agent, in relapsing remitting multiple sclerosis (MS) patients, met its primary end-point.

Laquinimod treatment significantly reduced the rate of inflammatory disease activity, as measured by the cumulative number of Gadolinium enhancing lesions on brain MRI scans after 36 weeks of treatment. Laquinimod treatment also demonstrated a considerable reduction in the number of clinical relapses compared to placebo. This Phase IIb multi-center, randomized, double-blind, placebo-controlled study enrolled approximately 300 patients in 8 European countries and in Israel.

The evaluation of the safety and side-effect data confirmed the favourable safety profile that was seen in earlier phase II clinical trials. The majority of the patients who participated in the study are currently continuing treatment with laquinimod in an ongoing, blinded extension study.

"The study results with once daily oral laquinimod are very encouraging and further demonstrate our ongoing commitment to developing new classes of therapies for MS, including oral therapies, to treat the disease, as well as to improve the patients' quality of life," said Israel Makov, President and CEO of Teva Pharmaceutical Industries Ltd.

"As of today, nearly 400 patients have received laquinimod in various clinical trials over the last years. The data from the completed studies together with preclinical documentation, confirm laquinimod's efficacy and favorable safety profile in MS patients," said Sven Andr'asson, President and CEO of Active Biotech AB.

The positive result of the clinical trial triggers a milestone payment to Active Biotech.

Further details about the study will be given at Teva's Innovative R&D Day in New York City on September 26th, 2006. A complete presentation of the Phase IIb data will be given at upcoming relevant scientific meetings.

Teva is discussing laquinimod's development plan with regulatory authorities in order to accelerate the clinical program into Phase III.

About Laquinimod:
Laquinimod is a novel once-daily, orally administered immunomodulatory compound developed as a disease modifying treatment for multiple sclerosis (MS). Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries Ltd. in June 2004 ....[MORE]"

2006-10-09T07:25:00.001-07:00

CAMPATH: "Genzyme Says MS Drug Works Better Than Serono's Rebif"..CLICK FOR MORE... Bloomberg.com:
Genzyme Corp. said its Campath drug was more effective in treating multiple sclerosis than Serono SA's Rebif, the second-best selling MS treatment worldwide.

MS patients had 75 percent fewer symptom relapses after two years of treatment with Campath than with Rebif, Cambridge, Massachusetts-based Genzyme said today in releasing interim results of a 334-patient study. The Genzyme-sponsored trial was suspended a year ago after a patient died from abnormal bleeding.

The results suggest that Campath may be an effective option for treating MS, a debilitating neurological disorder that affects more than 2.5 million people worldwide, analysts said. A plan by Genzyme to reduce the bleeding risk may help persuade regulators to allow a larger patient study needed to win U.S. regulatory approval, the company said

``Patients and physicians are willing to take on a certain amount of risk when you have new opportunities to combat this debilitating disease,'' Aaron Reames, an analyst with A.G. Edwards in Boston said today in an interview. ``This is definitely positive data.''

The U.S. Food and Drug Administration in June approved Biogen Idec Inc.' Tysabri MS drug, which had been withdrawn more than a year ago because of a fatal side effect. The FDA allowed Tysabri back on the market after the company set up procedures designed to have doctors closely monitor patients. Biogen's Avonex is the world's top-selling MS medicine.

Safety Data

Shares of Genzyme, based in Cambridge, Massachusetts, gained $1.80, or 2.7 percent, to $68.35 in Nasdaq Stock Market composite trading. They had fallen 6 percent this year before today. Serono fell 8 Swiss francs to 871.5 francs in Zurich.

Safety data from the trial will be presented later this month at the meeting of the European Committee for Treatment and Research in MS in Madrid. Final results from the three-year trial are due in a year from now.

MS robs people of muscle coordination and balance, and can lead to damaged vision and paralysis. The disease is caused when the body's immune system attacks myelin, the coating on nerve fibers. In severe MS, people have permanent symptoms, including partial or complete paralysis.

The Campath study compared the drug to Rebif in patients with a form of the disease, called relapsing/remitting MS, in which a flare-up of symptoms is followed by remission.

Genzyme said today it requested a meeting with the FDA to present the data and to address the next steps in the drug's development. The company has already received scientific advice from the European Medicines Agency for moving forward into the last of three stages of human tests needed for regulatory approval.....MORE

2006-10-09T07:25:00.000-07:00

Pfizer's Lyrica(R) (Pregabalin Capsules) Approved in Europe for Difficult-to-Treat Nerve Pain....CLICK FOR FULL ARTICLE

Lyrica's neuropathic pain indication broadened to include central nerve pain; Central nerve pain is associated with conditions such as spinal cord injury, stroke, and multiple sclerosis

A robust and unprecedented clinical program involving more than 10,000 patients supports Lyrica's efficacy and safety in treating a broad range of neurological disorders

Medical Expert: 'Physicians will be in a better position to manage a whole host of difficult-to-treat nerve pains for many of their patients.'

NEW YORK, NY -- September 19, 2006 -- Pfizer Inc said today that the European Commission approved Lyrica(R) (pregabalin capsules) to treat central neuropathic (nerve) pain.

This new approval broadens the current range of neuropathic pain that Lyrica is approved to treat in Europe to include nerve pain associated with conditions such as spinal cord injury, stroke, and multiple sclerosis.

Central neuropathic pain can be an especially difficult-to-treat condition, often requiring the use of strong narcotics. Lyrica's approval in central neuropathic pain provides further evidence of its robust efficacy in even the most hard to treat neuropathic pain conditions. Now, Lyrica is the only medication approved in the EU to treat both peripheral and central neuropathic pain, which affects up to 7.7 million people in Europe.

Developed by Pfizer, Lyrica is believed to work by calming hyper-excited neurons which may be an underlying cause for various types of nerve pain......more

2006-10-09T07:24:00.001-07:00

NovaDel Announces Two CNS Oral Spray Drug Candidates in its Development Pipeline; Oral Spray Formulations of Tizanidine for Spasticity...CLICK HERE - Forbes.comNovaDel's oral spray technology may be particularly applicable to drugs for the treatment of CNS disorders where the oral sprays ability to overcome difficulty in swallowing tablets and achieving rapid onset of action could fulfill important unmet medical needs for patients," commented Jan Egberts, M.D., CEO of NovaDel. "For instance, we expect that the ease of administering Tizanidine Oral Spray will be well suited to patients suffering from spasticity, which often includes difficulty in swallowing and drugs administered via tablet represent an obstacle to treatment......

2006-10-09T07:24:00.000-07:00

"Daily Nicotinamide Shots May Protect MS Patients From Severe Disability"...MORE
"Giving multiple sclerosis (MS) patients a daily shot of nicotinamide may protect them from the risk of nerve degeneration and long-term severe disability, say researchers from the Children's Hospital, Boston, USA, who managed to do this with mice with Experimental Autoimmune Encephalitis (symptoms are similar to MS). Nicotinamide is a form of vitamin B3.....

2006-10-09T07:23:00.001-07:00

Vitamin B3 May Protect Nerves in MS Patients - Los Angeles Times...[MORE]
¶Research in mice suggests that a commonly used vitamin called nicotinamide can alleviate the symptoms of the most severe form of multiple sclerosis by protecting nerve fibers from damage. Currently, there is no effective treatment for this phase of the disease, called chronic progressive MS....

2006-10-09T07:23:00.000-07:00

TOVAXIN: New drug in the pipeline...CLICK FOR MORE
"Opexa Therapeutics, Inc. (OPXA) announced a number of positive steps in the Company's development including: -- Its Phase IIb study with Tovaxin(TM) for the treatment of multiple sclerosis has begun. -- Positive data from the Phase I/II trial with Tovaxin in multiple sclerosis indicate that after 12 months, patients exhibited a relapse rate reduction of more than 90%.

Initiation of animal studies at the University of Texas Medical Branch at Galveston utilizing the Company's autologous adult human stem cell regenerative medicine platform technology."

2006-10-09T07:22:00.001-07:00

"Acorda Drug Helps MS Patients in Walking; Shares Soar..CLICK FOR MORE
Sept. 25 (Bloomberg) -- Shares of Acorda Therapeutics Inc. more than tripled after the company said its experimental Fampridine drug helped people with multiple sclerosis walk faster.

Patients who took Fampridine-SR moved 25 percent faster on average during a timed 25-foot walk, while patients getting a placebo improved 4.7 percent, Hawthorne, New York-based Acorda said today. Patients on the drug also had increased leg strength, even those who didn't show improvement in walking.

Chief Executive Officer Ron Cohen said the company believes it met all three criteria the U.S. Food and Drug Administration set to establish that the drug works and plans to meet with the agency as soon as possible. About 80 percent of the 400,000 Americans with multiple sclerosis have some trouble walking, according to the company.

``It's a drug to help improve the symptoms of MS, and there's not any other product labeled to help with walking disability,'' said Philip Nadeau, an analyst with Cowen & Co. in New York, in a telephone interview. ``It will be complementary to everything that's out there right now.....

2006-10-09T07:22:00.000-07:00

ORAL FINGOLIMOD MAY REDUCE DISEASE ACTIVITY IN RELAPSING MS

[The New England Journal of Medicine 2006;1124-1140, 1088-1091]
"Results of a proof-of-concept randomized trial of fingolimod, an oral immune-modulating drug, show that treatment reduced the number of gadolinium-enhancing lesions on MRI as well as relapse-related clinical end points in patients with relapsing multiple sclerosis (MS).

'Our results show that oral fingolimod may be a treatment option for relapsing multiple sclerosis,' the researchers, with first author Ludwig Kappos, MD, from the University Hospital, Basel, Switzerland, conclude in their report. 'Before these findings can be considered clinically directive, the benefits and risks of fingolimod need to be further evaluated in larger-scale, longer-term clinical studies."

2006-10-09T07:19:00.000-07:00

Computer-Based Cognitive Rehab Improves Attentional Functions in MS Patients: Presented at ECTRIMS
[Presentation title: Effects of Cognitive Rehabilitation in Multiple Sclerosis. Abstract P428]

Computer-based drill and practice cognitive rehabilitation can be used to help improve attentional functions in patients with MS researchers reported here at the 22nd Congress of the European Committee for Treatment and research in Multiple Sclerosis (ECTRIMS).

"Speech information processing in attentional tasks gets better with a cognitive rehabilitation program that is computerised and tailor made," said lead investigator Marta Renom, BA, speech and language therapist, Multiple Sclerosis Foundation - Day Hospital, Barcelona, Spain. She presented the findings on September 28th....

Statistically significant improvements were observed in the treatment group that received computer-based rehabilitation. Reaction times in tonic alertness (P = .035), phasic alertness (P = .017) and divided attention (P = .017) all improved significantly.

"Less consistent changes were found for executive functions subtests, memory and language domains, as well as emotional and quality of life indicators," the authors wrote.....

The investigators concluded that a computer-based drill and practice cognitive rehabilitation program could be useful for improving attentional functions in patients with MS.

"The most basic attentional function (tonic alertness) seems to be the most sensitive. Its effect on other cognitive domains such as executive functions, language and memory is less well defined, as well as its generalisation to quality of life and emotional aspects," they added.

2006-10-09T07:15:00.000-07:00

BIOGEN NOW HAS 5 MS DRUGS: Adding a fifth product to its portfolio of approved and investigational MS therapies...Biogen is 'hoping to offer MS patients a portfolio of potential therapies.'"(CLICK FOR MORE)

Biogen markets two approved MS therapies:

Avonex, a once-weekly interferon beta-1a injection, pulled in revenues of $429 million for the second quarter
Tysabri (natalizumab), an alpha-4 antagonist administered by infusion, was voluntarily pulled from the market by Biogen and partner, Dublin, Ireland-based Elan Corp. plc, last year after being linked to a fatal brain infection, but gained a second approval in June in a limited capacity

Biogen's development pipeline for MS includes:

Rituxan (rituximab), a B-cell targeted therapy that is in Phase II. That product, partnered with South San Francisco-based Genentech Inc., is marketed for rheumatoid arthritis and non-Hodgkin's lymphoma.
Daclizumab is also in Phase II. Daclizumab, an antibody designed to bind to the IL-2 receptor on activated T cells. Daclizumab was one of three products Biogen licensed from Protein Design Labs Inc., of Fremont, Calif., in an August 2005 deal potentially worth up to $800 million
Oral CDP323, an oral alpha-4 integrin inhibitor discovered by UCB. A small-molecule prodrug antagonist of alpha-4 integrin, CDP323 has been tested in three Phase I trials in healthy volunteers. Data from those trials was reported last week at the 2006 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain.

2006-10-09T07:13:00.000-07:00

Interferon benefits early multiple sclerosis [Click for full article - Scientific American]
Early and ongoing treatment with interferon beta-1a can provide lasting benefits to patients with relapsing-remitting multiple sclerosis (MS), according to a report in the journal Neurology.

Multiple sclerosis is thought to be an autoimmune disease, a disease that occurs when the body's own immune system attacks a key protein covering on the nerves, resulting in serious movement problems and other symptoms.

With relapsing-remitting MS, the initial form of the disease in 85 percent of patients, MS attacks are separated by periods of relatively normal function.

"Long-term treatment with (interferon beta-1a) is feasible and tolerated by most patients with some evidence of sustained benefit regarding clinical disease progression and MRI related outcomes," Dr. Ludwig Kappos from University Hospital Basel, Switzerland told Reuters Health.
Kappos and colleagues report follow-up data for up to 8 years after entry of patients into the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study.

Early treatment with interferon beta-1a, particularly at a high dose, helped prevent disease relapses, the researchers note. Moreover, early treatment appeared to slow long-term disease progression based on MRI findings.

Treatment with interferon was generally well tolerated, the investigators say, with no new safety concerns.
"This trial represents another enormous expenditure of effort to determine whether we are helping our relapsing-remitting MS patients with existing therapies," writes Dr. John H. Noseworthy from the Mayo Clinic College of Medicine, Rochester, Minnesota in a related editorial.

"I respect this effort," Noseworthy concludes, "but am cautious about the authors' conclusions that 'patients with relapsing-remitting MS can experience sustained benefit over many years from early interferon beta-1a...three times weekly therapy.' Perhaps this is true (I hope it is), but the evidence is not yet fully convincing to me.".......

2006-10-09T07:11:00.000-07:00

CDP323 : Biogen Idec Press Release: UCB and Biogen Idec to Collaborate on Oral Multiple Sclerosis Therapy
UCB (Euronext Brussels: UCB) and Biogen Idec (NASDAQ: BIIB) today announced a global collaboration to jointly develop and commercialize CDP323 for the treatment of relapsing-remitting multiple sclerosis (MS) and other potential indications. CDP323 is an orally active small molecule a4-integrin inhibitor expected to enter Phase II clinical trials next year.

"Multiple Sclerosis affects more than a million people worldwide and we are delighted to be collaborating with Biogen Idec on our exciting CDP323 program. CDP323 has arisen from UCB's in-depth understanding of integrin biology and chemistry to address this difficult protein target. Our outstanding Phase I results encourage us to move rapidly into Phase II trials in MS patients. We believe that if trials are successful CDP323 could make a real difference for MS patients with this severe and debilitating disease," stated Melanie Lee, Executive Vice President, Research & Development for UCB.

"We are always looking to enhance and expand our arsenal in the fight against MS," said Al Sandrock, Senior Vice President, Neurology Research and Development for Biogen Idec. "Another effective oral therapy would augment Biogen Idec's broad portfolio of products and potential therapies in development for this debilitating disease

About CDP323
CDP323 is a potent and orally active small molecule prodrug antagonist of a4-integrins. The safety, tolerability and pharmacokinetic profile of CDP323 have been evaluated in healthy volunteers in three separate Phase I studies. CDP323 was well tolerated with an adverse event profile comparable to placebo. Data from these studies have been reported at the 2006 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)....

2006-10-09T07:10:00.000-07:00

2006-10-09T07:09:00.000-07:00

2006-10-08T21:33:00.000-07:00

2006-10-08T21:28:00.000-07:00

Fingolimod Effective to 24 Months in Relapsing MS.../MORE
October 10, 2006 (Chicago) — Results of an extension study with oral fingolimod in patients with relapsing multiple sclerosis (MS) continue to show reduced disease activity on MRI as well as low rates of relapse, in both patients who received the drug continuously through 24 months and patients who had been randomized to placebo during the main study and were switched to active drug after the study closed at 12 months.

"The summary is that there were no new side effects, and the effect was of the same level, so it confirms the results that we had in the first 12 months," lead author Ludwig Kappos, MD, from the University Hospital in Basel, Switzerland, told Medscape.

Main results of this phase 2 trial, supported by Novartis Pharma in Basel, Switzerland, were published in the September 14, 2006 issue of the New England Journal of Medicine (2006;355:1124-1140). Results of the extension trial out to 24 months were presented here at the American Neurological Association (ANA) 131st Annual Meeting.

Confirming Previous Findings

Fingolimod is a still-investigational drug that, given orally, acts as a superagonist to sphingosine-1-phosphate (S1P) receptors on the surface of thymocytes and lymphocytes, causing them to be sequestered in secondary lymph organs. This reduces the overall number of circulating lymphocytes available to mount an autoimmune reaction to the myelin sheath surrounding axons in MS....

These positive results, the authors conclude, warrant continued investigation of the drug; the open-label extension continues, with all patients receiving the 1.25-mg dose of fingolimod.

"It has now entered phase 3, with 2 large studies, 1 comparing the drug with placebo for 2 years, and another comparing fingolimod with 1 of the approved interferons for 1 year" in relapsing MS patients, Dr. Kappos said. They will use the 1.25-mg dose, the authors note, and plan to evaluate an even lower dose of 0.5 mg....

2006-10-08T21:26:00.001-07:00

Promising new results for Fingolimod: a UK MS Society Press Release [click for more]:
"Novartis Pharmaceuticals have presented new positive results with Fingolimod (FTY720) and have initiated a worldwide phase III clinical study.

Following a two-year phase II clinical study, Novartis reported a relapse rate reduction of more then 50%, compared to placebo, with 77% of people taking Fingolimod remaining relapse-free over two years. In addition, more than 80% of people were free from lesions showing active inflammation on MRI. People taking placebo in the first six months of the trial experienced a similar improvement, when switched to Fingolimod. This finding was sustained for 24 months.

Overall, the drug was well tolerated. Reported side effects were usually mild and included: upper respiratory tract infections, nausea, diarrhoea, initial decrease in heart rate and an increase in blood pressure.

Simon Gillespie, chief executive at the MS Society, said: ‘we are excited at the prospect of an effective and well tolerated oral treatment for relapsing remitting MS which is urgently needed and welcome the initiation of phase III clinical trial.”

Based on the promising phase II results, Novartis has initiated a phase III study programme with plans to involve more than 3000 people with MS worldwide.

The first planned multi-centre study, called FREEDOMS plans to evaluate the effectiveness and safety of two different doses of Fingolimod, compared to placebo over 24 months. It will be recruiting people between the age of 18 and 55 with relapsing-remitting MS that must have experienced 1 relapse in the last year or 2 relapses in the last 2 years.

Confirmed participating clinical centres (not recruiting yet) in the UK include: The Royal Victoria Infirmary, Newcastle-upon-Tyne;
Queens Medical Centre, Nottingham; Hope Hospital, Salford; Royal Hallamshire Hospital, Sheffield; Barts and the London NHS Trust, The Royal London Hospital, St. George's Hospital, Tooting and King's College Hospital in London. For more details on this study please refer to http://www.clinicaltrials.gov/ct/show/NCT00289978

What is Fingolimod?

Fingolimod (FTY720) is a new oral immunomodulating treatment under evaluation for the treatment of relapsing remitting MS. It's a chemical derivative of a metabolite produced by a fungus used in traditional Chinese medicine.

Fingolimod has a novel mechanism of action. It binds to a receptor on a proportion of circulating immune cells and reversibly traps them in the lymph nodes. As a result, Fingolimod lowers the number of activated immune cells circulating in the blood stream and prevents them from attacking the brain and spinal cord.
"

2006-10-08T21:26:00.000-07:00

2006-10-08T21:12:00.000-07:00

ORAL FINGOLIMOD - Acorda Therapeutics to double work forceThe company's shares have climbed more than 190 percent since an initial public offering on Feb. 9. That is the largest gain this year in The Journal News/Bloomberg index, which tracks companies with a corporate headquarters or major local presence in Westchester, Rockland or Putnam counties.

Most of the gain in the stock price has come during the past month as investors reacted to upbeat news about a MS drug under development at Acorda. If the drug receives regulatory approval, it could one day make walking easier for the 320,000 Americans with MS who deal with mobility problems. Acorda has been working on the development of the drug since the mid-1990s. That was when Acorda acquired the rights to the medication from Elan, a pharmaceutical company in Ireland.
MORE/a>

2006-10-04T20:42:00.000-07:00

Avonex, a once-weekly interferon beta-1a injection, pulled in revenues of $429 million for the second quarter
Tysabri (natalizumab), an alpha-4 antagonist administered by infusion, was voluntarily pulled from the market by Biogen and partner, Dublin, Ireland-based Elan Corp. plc, last year after being linked to a fatal brain infection, but gained a second approval in June in a limited capacity

Biogen's development pipeline for MS includes:

Rituxan (rituximab), a B-cell targeted therapy that is in Phase II. That product, partnered with South San Francisco-based Genentech Inc., is marketed for rheumatoid arthritis and non-Hodgkin's lymphoma.
Daclizumab is also in Phase II. Daclizumab, an antibody designed to bind to the IL-2 receptor on activated T cells. Daclizumab was one of three products Biogen licensed from Protein Design Labs Inc., of Fremont, Calif., in an August 2005 deal potentially worth up to $800 million
Oral CDP323, an oral alpha-4 integrin inhibitor discovered by UCB. A small-molecule prodrug antagonist of alpha-4 integrin, CDP323 has been tested in three Phase I trials in healthy volunteers. Data from those trials was reported last week at the 2006 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain.

THIS PAGE IS UNDER CONSTRUCTION...SOME RECENT HEADLINES HAVE NOT BEEN TRANFERRED TO THIS NEW SITE

2006-10-04T08:15:00.000-07:00

DR. TIMOTHY VOLLMER IS WRITING AN ARTICLE FOR US ON THE 5 TREATMENTS HE FEELS ARE MOST PROMISING...OUT OF ALL OF THE NEW MS TREATMENTS THAT WERE ANNOUNCED AT ECTRIMS: The 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis...September 27–30 in Madrid, Spain

ALERT #41 WILL BE SENT TO YOU THIS WEEKEND - Click here if you haven't requested our weekly MS Drug Alerts

HERE'S 27 NEW MS TREATMENTS WE'VE POSTED IN THE LAST 2 WEEKS:

SCROLL DOWN..BELOW THIS POST..FOR THE FULL STORY ON EACH HEADLINE:

1...TYSABRI HELPS COGNITION: Tysabri reduced the risk of sustained cognitive worsening by 43 percent, compared to placebo.....

2...CAMPATH: "Genzyme Says MS Drug Works Better Than Serono's Rebif"

3...ORAL FINGOLIMOD - FTY720: Presented at ECTRIMS
Oral FTY720 (Fingolimod) for Relapsing Multiple Sclerosis Shows Sustained Benefits for Up to 2 Years

4....NEW REBIF AUTO-INJECTOR: ECTRIMS Presentation on new-improved Rebif PLUS It's new auto-injector, which uses the thinnest needle of any treatment!!!
New Formulation Rebif for Relapsing Multiple Sclerosis Lowers Immunogenicity and Improves Tolerability

5...ORAL LAQUINIMODE BY TEVA: The NEW once-daily novel oral agent for relapsing remitting

6...ORAL FAMPRIDINE-SR BY SERONO: FDA fast-tracks Serono's oral MS drug Cladribine...
Patients who took Fampridine-SR moved 25 percent faster ontimed 25-foot walk, while patients getting a placebo improved 4.7 percent, Hawthorne

7...COPAXONE(R) Showed Sustained Benefit on Slowing Brain Tissue Damage in Multiple Sclerosis Patients
Data presented last week at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

8...FATIGUE AND FUNCTIONAL DEFICIT IMPROVEMENT: Four-week Rehab Significantly Improves Fatigue and Functional Deficit in Multiple Sclerosis Patients: Presented at ECTRIMS
Fatigue and functional deficits in multiple sclerosis (MS) patients were significantly improved during 4 weeks of inpatient rehabilitation, researchers reported here at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)....

9...SATIVEX - CANNABINOID-BASED DRUG: Savitex Appears Helpful for Spasticity in Multiple Sclerosis: Presented at ECTRIMS

10...MBP8298: New Drug in the Pipeline...A message from Ryan Giese

11...CDP323: NEW DRUG IN PIPELINE - Biogen Idec:
"Biogen Idec and UCB and to collaborate on oral multiple sclerosis therapy U.C.B. and BIIB announce a global collaboration to jointly develop and commercialize CDP323 for the treatment of relapsing-remitting multiple sclerosis...

12...PPMS: Small Study Holds Hope For chronic progressive patients with MS [PPMS]

13...COPAXONE New Data Confirmed Antibodies to Copaxone® Do Not Impact Its Established and Sustained Long-Term Efficacy in Multiple Sclerosis

14...COPAXONE WITH MITOXANTRONE: Very Active Multiple Sclerosis Patients Benefited From COPAXONE(R) Treatment Following Short-Term Induction With Mitoxantrone

15...AVONEX PRESS RELEASE FROM ECTRIMS
....treatment with AVONEX (Interferon beta-1a) promoted a statistically significant recovery of T1-black hole lesion volume by almost 24%....

16...LYRICA: Pfizer's Lyrica(Pregabalin Capsules) Approved in Europe for Difficult-to-Treat Nerve Pain.

17...MBP8298 shown to safely delay disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. BioMS Medical to present at the 22nd Congress of the European Com mittee for Treatment and Research in Multiple Sclerosis (ECTRIMS) :

18..."Testosterone gel proven to slow symptoms of MS...in small study": UCLA School of Medicine,

19...TYSABRI - Presented at ECTRIMS
Natalizumab (Tysabri) Reduces Brain Atrophy, Improves Cognition During Second Year of Multiple Sclerosis Treatment

20...TOVAXIN: New drug in the pipeline

21...REBIF: NEW FORMULATION: ONE-YEAR DATA FROM PHASE III TRIAL SHOW THAT NEW FORMULATION OF REBIF® OFFERS SUBSTANTIAL IMPROVEMENT IN TOLERABILITY AND IMMUNOGENICITY PROFILES...[click for full press release]:

22...NovaDel Announces Two CNS Oral Spray Drug Candidates in its Development Pipeline; Oral Spray Formulations of Tizanidine for Spasticity

23...SYMADEX...NEW DRUG ANNOUNCEMENT FROM ECTRIMS
Symadex Can Reverse Disease in Preclinical Multiple Sclerosis Animal Model

24...NICOTINAMIDE: "Daily Nicotinamide Shots May Protect MS Patients From Severe Disability"

25...Gene found that helps combat MS [MORE: BBC NEWS]
A gene that helps to stave off the effects of multiple sclerosis (MS) has been discovered by scientists. A Danish-UK team found that a known risk gene for MS, called DR2b, is always partnered by a twin gene - DR2a....

26...Novantrone (mitoxantrone)... Safety and Tolerability of Mitoxantrone for Worsening Multiple Sclerosis Appears Stable in Long Term: Presented at ECTRIMS...

27...Age Should Not Deter Multiple Sclerosis Diagnosis: Presented at ECTRIMS

SCROLL DOWN FOR THE STORIES BEHIND THE 27 HEADLINES ABOVE

DRUG ALERT #41 WILL BE SENT TO YOU THIS WEEKEND - Click here if you haven't requested our weekly Drug Alerts

2006-10-02T23:58:00.000-07:00

MBP8298: New Drug in the Pipeline...Ryan Giese gave me this message for you:

2006-09-30T23:14:00.000-07:00

Click Here to go to Bioms Medical's Home Page

"Hi Stan,

It was nice talking to you again!

BioMS has one mission: to deliver a safe and effective treatment for MS
patients and we are well on our way.

MBP8298 is based on ground-breaking research and has successfully completed phase I and II clinical trials.

Currently we are in an international phase III trial for secondary
progressive MS in Canada and Europe.

BioMS expects to commence a similar phase III trial in the US in the first half of 2007.

Recently the European Journal of Neurology published data that showed MBP8298 safely delayed disease progression in an HLA-defined subgroup of MS patients for an unprecedented 5 years. It is my hope that all MS patients can potentially benefit from this exciting research.

Please feel free to call me if you need any more information on MBP8298. I will give you any information that we are able to release to the public...immediately...so you can give it to your MS patients and their families"

Ryan Giese
Vice President Corporate Communications
BioMS Medical Corp

2006-09-28T22:11:00.000-07:00

New MS oral treatment improves symptoms
Novartis has reported new phase II results of FTY720 that show a sustained reduction in relapses and inflammation in multiple sclerosis patients over a two year period.

New phase II data presented demonstrated that up to 77% of patients taking once-daily oral FTY720 remained free of relapses over two years. They also maintained a low rate of inflammatory disease.

New preclinical data also suggested that FTY720 may work through multiple modes of action. In addition to its anti-inflammatory effects, preclinical data suggest that FTY720 may have the potential to reduce neurodegeneration and enhance repair of the central nervous system.

FTY720, the first oral sphingosine 1-phosphate receptor (S1P-R) modulator, may represent a new approach to the treatment of MS through its unique mode of action.

In MS, inflammatory lymphocytes (T-cells) are believed to be responsible for the destruction of the protective myelin coating, which surrounds the nerves in key areas of the brain and spinal cord. This destruction hinders the ability of nerves to send electrical signals, resulting in problems with muscle movement, coordination, balance and cognition.

FTY720 binds to the sphingosine 1-phosphate receptor-1 (S1P1) on circulating lymphocytes and reversibly traps a proportion of them in the lymph nodes. As a result, FTY720 lowers the number of activated T-cells circulating in the bloodstream and central nervous system.

FTY720 has been developed by Novartis and licensed from Mitsubishi Pharma Corporation.

2006-09-28T18:18:00.000-07:00

2006-09-28T18:15:00.000-07:00

Symadex Can Reverse Disease in Preclinical Multiple Sclerosis Animal Model
"Xanthus Pharmaceuticals Inc., a privately-held drug development company, today presented data that Symadex(TM) reverses the clinical and pathological signs of chronic disease in an animal model for multiple sclerosis (MS). The presentation was made by Stephen J. Karlik, PhD, Professor of Diagnostic Radiology at the University of Western Ontario, London, Ontario, together with researchers from Xanthus in aposter session at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Madrid, Spain.

Dr. Karlik used a model of experimental allergic encephalomyelitis(EAE) for the study. This same model was used by Dr. Karlik and his colleagues for published studies with natalizumab and related molecules. The study demonstrated that Symadex can reverse the clinical and pathological signs of chronic disease and that it can permit nerve remyelination. In addition, longer dosing resulted in continued benefit and the pathological changes including inflammation and vascular abnormalities were reversed. Importantly, Symadex did not affect circulating immune cell numbers, suggesting that it is not a general immunosuppressive agent....MORE

2006-09-20T22:52:00.000-07:00

SERONO'S ORAL CLADRIBINE FOR THE TREATMENT OF MULTIPLE SCLEROSIS AWARDED FAST TRACK STATUS BY FDA

Geneva, Switzerland, September 21, 2006 - Serono (virt-x: SEO and NYSE: SRA) announced today that oral cladribine has been designated a Fast Track product by the US Food and Drug Administration (FDA). This designation covers patients with relapsing forms of multiple sclerosis.

Serono’s proprietary oral formulation of cladribine for the treatment of multiple sclerosis is currently being evaluated in a multi-center, multi-national Phase III study, CLARITY (CLAdRIbine Tablets Treating MS OrallY) . It is a two-year, double-blind, placebo-controlled study involving over 1,200 patients. Patient enrollment into this pivotal trial is planned to be completed by the end of 2006.

“We are very pleased that oral cladribine has been designated a Fast Track product,” said Ernesto Bertarelli, CEO of Serono. “As a leader in multiple sclerosis, we are committed to providing new treatment options that can further improve the quality of the lives of people with this serious disease and our objective is to bring to them the first oral disease modifying treatment.”

"Thanks to decades of research, there are injectible drugs available to treat some forms of MS, but there is certainly a need for more and even better therapies to treat all forms of the disease. Having an effective oral therapy for MS would be a major step forward in improving quality of life for people with MS," said Dr. John Richert, Vice President, Research and Clinical Programs, at the National Multiple Sclerosis Society.

Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Under Fast Track designation oral cladribine is eligible for Priority Review and FDA may consider for review portions of the marketing application before the New Drug Application (NDA) is completed.

About cladribine

Cladribine is a purine nucleoside analogue that interferes with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of multiple sclerosis. Through its differentiated mechanism of action, oral cladribine may offer an alternative option to patients with multiple sclerosis.

2006-09-20T08:36:00.000-07:00

New Patent for MS drug: PHARMACEUTICAL COMPOSITION COMPRISING A ZINC-HYALURONATE COMPLEX
FOR THE TREATMENT OF MS

2006-09-20T08:26:00.000-07:00

NovaDel Announces Two CNS Oral Spray Drug Candidates in its Development Pipeline; Oral Spray Formulations of Tizanidine for Spasticity [CLICK HERE - Forbes.com]NovaDel's oral spray technology may be particularly applicable to drugs for the treatment of CNS disorders where the oral sprays ability to overcome difficulty in swallowing tablets and achieving rapid onset of action could fulfill important unmet medical needs for patients," commented Jan Egberts, M.D., CEO of NovaDel. "For instance, we expect that the ease of administering Tizanidine Oral Spray will be well suited to patients suffering from spasticity, which often includes difficulty in swallowing and drugs administered via tablet represent an obstacle to treatment......

2006-09-19T08:30:00.000-07:00

TOVAXIN: Click for Opexa Therapeutics Home Page
"Opexa Therapeutics, Inc. (OPXA) announced a number of positive steps in the Company's development including: -- Its Phase IIb study with Tovaxin(TM) for the treatment of multiple sclerosis has begun. -- Positive data from the Phase I/II trial with Tovaxin in multiple sclerosis indicate that after 12 months, patients exhibited a relapse rate reduction of more than 90%.

Initiation of animal studies at the University of Texas Medical Branch at Galveston utilizing the Company's autologous adult human stem cell regenerative medicine platform technology."

2006-09-19T08:21:00.000-07:00

>PRESS RELEASE BY TEVA: LAQUINIMOD -The once-daily novel oral agent for relapsing remitting MS....CLICK: FULL ARTICLE

"Laquinimod Phase IIb Trial confirms efficacy and favorable safety profile and shows significant reduction in the rate of inflammatory disease activity

The once-daily novel oral agent for relapsing remitting multiple sclerosis (MS) patients met its primary end-point."

"Jerusalem, Israel and Lund, Sweden, September 5, 2006 - Teva Pharmaceutical Industries Ltd (Nasdaq: TEVA) and Active Biotech AB (ACTI.ST) today announced that a Phase IIb study designed to evaluate the safety and efficacy of laquinimod, a once-daily novel oral agent, in relapsing remitting multiple sclerosis (MS) patients, met its primary end-point.

Laquinimod treatment significantly reduced the rate of inflammatory disease activity, as measured by the cumulative number of Gadolinium enhancing lesions on brain MRI scans after 36 weeks of treatment. Laquinimod treatment also demonstrated a considerable reduction in the number of clinical relapses compared to placebo. This Phase IIb multi-center, randomized, double-blind, placebo-controlled study enrolled approximately 300 patients in 8 European countries and in Israel.

The evaluation of the safety and side-effect data confirmed the favourable safety profile that was seen in earlier phase II clinical trials. The majority of the patients who participated in the study are currently continuing treatment with laquinimod in an ongoing, blinded extension study.

"The study results with once daily oral laquinimod are very encouraging and further demonstrate our ongoing commitment to developing new classes of therapies for MS, including oral therapies, to treat the disease, as well as to improve the patients' quality of life," said Israel Makov, President and CEO of Teva Pharmaceutical Industries Ltd.

"As of today, nearly 400 patients have received laquinimod in various clinical trials over the last years. The data from the completed studies together with preclinical documentation, confirm laquinimod's efficacy and favorable safety profile in MS patients," said Sven Andr'asson, President and CEO of Active Biotech AB.

The positive result of the clinical trial triggers a milestone payment to Active Biotech.

Further details about the study will be given at Teva's Innovative R&D Day in New York City on September 26th, 2006. A complete presentation of the Phase IIb data will be given at upcoming relevant scientific meetings.

Teva is discussing laquinimod's development plan with regulatory authorities in order to accelerate the clinical program into Phase III.

About Laquinimod:
Laquinimod is a novel once-daily, orally administered immunomodulatory compound developed as a disease modifying treatment for multiple sclerosis (MS). Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries Ltd. in June 2004 ....[MORE]"

2006-09-18T08:36:00.000-07:00

A possible advance in fight against MS by Researchers at Children's Hospital Boston, the pediatric teaching hospital for Harvard Medical School...CLICK FOR FULL ARTICLE:
"...The experiments, described Wednesday in the Journal of Neuroscience, showed that nicotinamide a form of vitamin B3, or niacin not only protected the animals' nerve fibers from degeneration and fatty insulating tissues loss, it also protected nerve fibers that have already lost insulation from degrading further.
'We hope our work will initiate a clinical trial, and that nicotinamide could be used in real patients,' said Dr. Shinjiro Kaneko, a research fellow at Children's who led the study. 'In the early phase of MS, anti-inflammatory drugs may work, but long-term, you need to protect against axonal (nerve fiber) damage.'

On a scale of 1 to 5 (with 1 being only mild weakness in the tail; 4, paralysis in all four limbs, and 5, death from the disease), mice receiving the highest doses of daily nicotinamide injections under the skin had scores of 1 or 2, while mice not getting the vitamin had scores of 3 or 4.
Nicotinamide significantly reduced neurological symptoms even when treatment was delayed for 10 days after the onset of disease in the mice, raising hopes that it can be effective in.... the later stages of MS in people. "

2006-09-18T08:35:00.000-07:00

Genzyme Corp. said its Campath drug was more effective in treating multiple sclerosis than Serono SA's Rebif, the second-best selling MS treatment worldwide [MORE... Bloomberg.com:]

MS patients had 75 percent fewer symptom relapses after two years of treatment with Campath than with Rebif, Cambridge, Massachusetts-based Genzyme said today in releasing interim results of a 334-patient study. The Genzyme-sponsored trial was suspended a year ago after a patient died from abnormal bleeding.

The results suggest that Campath may be an effective option for treating MS, a debilitating neurological disorder that affects more than 2.5 million people worldwide, analysts said. A plan by Genzyme to reduce the bleeding risk may help persuade regulators to allow a larger patient study needed to win U.S. regulatory approval, the company said

``Patients and physicians are willing to take on a certain amount of risk when you have new opportunities to combat this debilitating disease,'' Aaron Reames, an analyst with A.G. Edwards in Boston said today in an interview. ``This is definitely positive data.''

The U.S. Food and Drug Administration in June approved Biogen Idec Inc.' Tysabri MS drug, which had been withdrawn more than a year ago because of a fatal side effect. The FDA allowed Tysabri back on the market after the company set up procedures designed to have doctors closely monitor patients. Biogen's Avonex is the world's top-selling MS medicine.

Safety Data

Shares of Genzyme, based in Cambridge, Massachusetts, gained $1.80, or 2.7 percent, to $68.35 in Nasdaq Stock Market composite trading. They had fallen 6 percent this year before today. Serono fell 8 Swiss francs to 871.5 francs in Zurich.

Safety data from the trial will be presented later this month at the meeting of the European Committee for Treatment and Research in MS in Madrid. Final results from the three-year trial are due in a year from now.

MS robs people of muscle coordination and balance, and can lead to damaged vision and paralysis. The disease is caused when the body's immune system attacks myelin, the coating on nerve fibers. In severe MS, people have permanent symptoms, including partial or complete paralysis.

The Campath study compared the drug to Rebif in patients with a form of the disease, called relapsing/remitting MS, in which a flare-up of symptoms is followed by remission.

Genzyme said today it requested a meeting with the FDA to present the data and to address the next steps in the drug's development. The company has already received scientific advice from the European Medicines Agency for moving forward into the last of three stages of human tests needed for regulatory approval.....MORE

2006-09-18T08:33:00.000-07:00

2006-09-18T08:28:00.000-07:00

Tovaxin: New drug in the pipeline

2006-09-18T08:20:00.000-07:00

New MS Drug: MBP8298...BioMS Medical Press Release: Pivotal MS Trial expanded.....FULL STORY

"BioMS Medical Expands Pivotal Multiple Sclerosis Trial into Spain and Germany

Edmonton, Alberta - BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced it has received approval from the Spanish Agency for Medicines and Healthcare Products (SAMHP) in Spain and from the Federal Institute for Medicines and Medical Products in Germany to start patient enrolment for its pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada , the U.K. , Sweden , Denmark and The Netherlands in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed five safety reviews by its independent Data Safety Monitoring Board."

Click the link in the headline to read more about BioMS Medical Corp.

2006-09-18T08:18:00.000-07:00

Oral Fingolimod May Reduce Disease Activity in Relapsing MS [UPDATE #1]CLICK FOR MORE
[The New England Journal of Medicine 2006;1124-1140, 1088-1091]
"Results of a proof-of-concept randomized trial of fingolimod, an oral immune-modulating drug, show that treatment reduced the number of gadolinium-enhancing lesions on MRI as well as relapse-related clinical end points in patients with relapsing multiple sclerosis (MS).

'Our results show that oral fingolimod may be a treatment option for relapsing multiple sclerosis,' the researchers, with first author Ludwig Kappos, MD, from the University Hospital, Basel, Switzerland, conclude in their report. 'Before these findings can be considered clinically directive, the benefits and risks of fingolimod need to be further evaluated in larger-scale, longer-term clinical studies."

2006-09-17T08:17:00.000-07:00

Genentech and Biogen Idec Announce Positive Results From a Phase 2 Trial of Rituxan in Relapsing-Remitting Ms
"Genentech, Inc. and Biogen Idec, Inc. announced today that a phase 2 study of Rituxan(R) (Rituximab) for relapsing-remitting multiple sclerosis (RRMS) met its primary endpoint. The study of 104 patients showed a statistically significant reduction in the total number of gadolinium enhancing T1 lesions observed on serial MRI scans of the brain at weeks 12, 16, 20, and 24 in the Rituxan-treated group compared to placebo. Genentech and Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.

This phase 2 randomized, double-blind, parallel-group, placebo-controlled, multi-center study was designed to evaluate safety and efficacy of Rituxan in adults with RRMS. A total of 104 patients at 48 sites in the U.S. and Canada were randomized to receive either a single treatment course of Rituxan or placebo. Gadolinium-enhancing lesions visible by MRI scans were assessed at 12, 16, 20 and 24 weeks. Patients will continue to be followed for 48 weeks.

"These initial results exceeded our expectations," said Hal Barron, MD, Genentech senior vice president, development and chief medical officer. "Showing a significant benefit at 24 weeks in this small phase 2 trial supports our hypothesis that selective B-cell targeted therapy may play an important role in the treatment of MS."

"Biogen Idec is committed to offering multiple options for people living with MS, a devastating disease. We are very encouraged by these data and look forward to learning more about the potential of Rituxan as a therapy to treat MS," said Alfred Sandrock, MD, PhD, senior vice president, neurology research and development, Biogen Idec.

Rates of overall adverse events and serious adverse events were comparable between the two treatment groups. Serious infectious adverse events occurring in Rituxan-treated patients included gastroenteritis and bronchitis. The overall rates of infection were comparable among the two treatment groups with an increase in the rates of nasopharyngitis, upper respiratory tract infections, urinary tract infections, and sinusitis in the Rituxan-treated patients. There were more first infusion-related reactions with Rituxan, the majority of which were mild to moderate and were generally reversible with medical intervention. The companies continue to monitor the long-term safety of Rituxan treatment.

Rituxan Safety Profile in Oncology and Autoimmune Diseases

The safety profile of Rituxan has been established in more than 960,000 patient exposures over a period of eight years.

In general, the adverse events observed in patients with RA, an autoimmune disease, were similar in type to those seen in patients with non-Hodgkin's lymphoma (NHL). The most common adverse events observed in patients treated with Rituxan for RA in clinical trials were infusion reactions and infections. No significant change in average immunoglobulin levels was observed in Rituxan-treated patients in clinical trials. There was no increase in hematologic malignancies, demyelinating events, or risk of opportunistic infections (including tuberculosis) in Rituxan-treated patients over 24 weeks of treatment. Although 5 percent of Rituxan-treated patients developed human anti-chimeric antibodies (HACA), this was not associated with loss of clinical response or additional safety observations.

The majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include but are not limited to: flu-like illness, fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema, hypotension and hypoxia. These symptoms vary in severity and generally are reversible with medical intervention....."

2006-09-16T08:12:00.000-07:00

NEW MS DRUG IN PIPELINE: STANFORD UNIVERSITY APPLIES FOR PATENT
"Method of treating rheumatoid arthritis and MS ...: "Applicant The Board of Trustees of the Leland Stanford Junior University...Inventor(s) Godfrey, Wayne
Engleman, Edgar G.....Abstract The invention provides ligands and fragments
thereof to a receptor on the surface of activated CD4+T-cells. An
exemplary ligand is designated ACT-4-L-h-1. Preferred fragments include
purified extracellular domains of ligands. The invention also provides
humanized and human antibodies to the ligand. The invention further provides
methods of using the ligand and the antibodies in treatment of diseases and
conditions of the immune system. The invention also provides methods of
monitoring activated CD4+T-cells using the ligands or fragments
thereof. If you would like to purchase a copy of this patent, please call MicroPatent at 800-648-6787."

2006-09-13T08:16:00.000-07:00

NovaDel Announces Two CNS Oral Spray Drug Candidates in its Development Pipeline; Oral Spray Formulations of Tizanidine for Spasticity ... - Forbes.comNovaDel's oral spray technology may be particularly applicable to drugs for the treatment of CNS disorders where the oral sprays ability to overcome difficulty in swallowing tablets and achieving rapid onset of action could fulfill important unmet medical needs for patients," commented Jan Egberts, M.D., CEO of NovaDel. "For instance, we expect that the ease of administering Tizanidine Oral Spray will be well suited to patients suffering from spasticity, which often includes difficulty in swallowing and drugs administered via tablet represent an obstacle to treatment......

2006-09-12T08:12:00.000-07:00

NEW MS MED IN EUROPE: "Sativex, the cannabis-derived product could be finally set for approval after a delay of around two years.
:
UK regulator, the MHRA, rejected the drug in December 2004, calling for a second clinical trial to prove its efficacy, which the company has now conducted, and which, it believes, proves that Sativex works. The company is seeking to treat multiple sclerosis spasticity, but hopes to eventually gain licences to treat peripheral neuropathic pain, MS neuropathic pain and cancer pain as well. GW Pharmaceuticals has filed Sativex for approval through the decentralised procedure for licences in just four European countries, the UK, Denmark, Spain and the Netherlands......"

2006-09-09T08:15:00.000-07:00

MBP8298....BioMS Medical Press Release: Pivotal Multiple Sclerosis Trial of MBP8298 expanded...

"BioMS Medical Expands Pivotal Multiple Sclerosis Trial into Spain and Germany

Edmonton, Alberta , September 7, 2006 - BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced it has received approval from the Spanish Agency for Medicines and Healthcare Products (SAMHP) in Spain and from the Federal Institute for Medicines and Medical Products in Germany to start patient enrolment for its pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada , the U.K. , Sweden , Denmark and The Netherlands in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed five safety reviews by its independent Data Safety Monitoring Board.

About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, MBP8298, is for the treatment of multiple sclerosis and is currently in a pivotal phase II/III clinical trial across Canada and Europe. For further information please visit our website at www.biomsmedical.com.

This news release may contain certain forward-looking statements that reflect the current views and/or expectations of BioMS Medical with respect to its performance, business and future events.

2006-09-05T08:11:00.000-07:00

2006-08-20T08:08:00.000-07:00

NEW DRUG IN THE PIPELINE FOR MS: Daclizumab for the treatment of MS:
"It's easy to understand the $800 million alliance forged between PDL Biopharma and Biogen Idec in August. The deal answers Biogen's pipeline needs and provides PDL a kindred biotech with experience in MS and cancer...The deal calls for PDL and Biogen to jointly develop, manufacture and sell three antibody products in mid-stage clinical trials. This includes PDL's drug Daclizumab for the treatment of MS......"

2006-08-20T07:49:00.000-07:00

NEW MS DRUG: Biogen, Genentech See Solid Rituxan Data

NEW YORK (AP) - Drug makers Biogen Idec Inc. and Genentech Inc. said Monday a mid-stage study of Rituxan showed it was effective in treating MS.

The Food and Drug Administration originally approved the drug in 1997 for the treatment of cancer. It was developed by Cambridge, Mass-based Biogen and is co-marketed with South San Francisco, Calif-based Genentech in the United States.

The companies said the treatment reached its primary endpoint in reducing the number of gadolinium enhancing T1 lesions, or indicators of relapsing forms of MS, in a 104-patient study. The clinical trial compared Rituxan to a placebo and took place over 24 weeks.

Patients involved in the study will be followed for an additional 48 weeks as the companies monitor the long-term safety affects of the treatment.

MS, an autoimmune disease, is the leading cause of neurological disorders in young adults, the companies said, with the relapsing form of the disease accounting for 65 percent of all MS cases....."

2006-08-18T08:32:00.000-07:00

Caraco gets FDA OK for generic MS drug - Pharmaceutical Business Review: "The FDA has granted final approval for Caraco Pharmaceutical's baclofen tablets, the company's generic version of Novartis' Lioresal, a muscle relaxant used for the alleviation of signs and symptoms of spasticity resulting from MS..."

2006-08-16T20:31:00.000-07:00

FDA Approves Baclofen for Spasticity in MS: "Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Baclofen Tablets.

Caraco's Baclofen Tablet is a muscle relaxant and antispastic. It is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Caraco has two strengths available, 10 mg and 20 mg tablets....."

2006-08-15T20:04:00.000-07:00

Tovaxin: Opexa Therapeutics T cell-based
therapeutic vaccine: "...we achieved a very significant milestone with the initiation of our randomized, placebo-controlled Phase IIb trial to evaluate the effectiveness of our T cell-based therapeutic vaccine, Tovaxin, for treating MS. We believe that Tovaxin attacks the underlying cause of MS and has advantages over existing treatments for the disease, including lower relapse rates, quick onset of action, minimal side effects, less frequent injections and reduced patient fatigue.'....."

2006-08-15T19:57:00.000-07:00

Chromos updates on progress with development of CHR-1103 for treatment of MS
"Chromos Molecular Systems Inc. (TSX: CHR) has taken several significant steps in the development of its lead product candidate, CHR-1103. A humanized monoclonal antibody, CHR-1103 is being developed for the acute treatment of relapsing forms of multiple sclerosis (MS). Its unique mechanism of action has the potential to reduce the severity of a relapse in patients with MS and also stem the residual neurological damage that often accompanies relapse and leads to progression of the disease.

Chromos recently completed its first meeting with officials from the U.S. Food and Drug Administration (FDA). The two parties discussed Chromos' clinical approach, proposed preclinical safety evaluation program and manufacture of CHR-1103. Chromos is now moving forward with preclinical safety evaluation studies in preparation for an Investigational New Drug (IND) application in Q3 2007.

Using its proprietary ACE System, Chromos engineered a stable clonal cell line expressing its product, CHR-1103 and transferred it to AppTec for process development, scale up and manufacture. The ACE System demonstrated the ability to perform well in large-scale manufacturing, validating the use of the platform for clinical and commercial scale manufacturing of biopharmaceuticals. The Company is now preparing to begin its preclinical safety evaluation studies with Charles River Laboratories.

Chromos has engaged two leading MS clinicians to act as clinical consultants for its CHR-1103 program. Lily Jung, M.D. is the Medical Director of the Seattle Neuroscience Institute at Swedish Medical Centre in Seattle, WA, and a clinical associate professor in Neurology at the University of Washington Medical School. Mariko Kita, M.D. is a clinical investigator and Director of the Virginia Mason Multiple Sclerosis Center in Seattle, WA. Drs. Jung and Kita will advise and assist with the clinical development of CHR-1103 as it enters clinical trials...."

2006-08-15T19:45:00.000-07:00

An unlikely MS therapy: MS responds to high doses of chemotherapy in study, improving health of five subjects:
"Stony Brook University Hospital's Dr. Douglas Gladstone enrolled a dozen patients into the experimental drug trial with cyclophosphamide, a powerful drug used to treat leukemia and lymphoma. It wipes out the body's immune system, which is exactly why Gladstone suspected it would work in multiple sclerosis. In the disease process, T-cells of the immune system attack the myelin sheath, the insulation around the nerve cells......"

CHR-1103

2006-08-15T07:18:00.000-07:00

Chromos updates on progress with development of CHR-1103 for treatment of MS:
" Chromos Molecular Systems
Inc. (TSX: CHR) has taken several significant steps in the development of its
lead product candidate, CHR-1103. A humanized monoclonal antibody, CHR-1103 is
being developed for the acute treatment of relapsing forms of multiple
sclerosis (MS). Its unique mechanism of action has the potential to reduce the
severity of a relapse in patients with MS and also stem the residual
neurological damage that often accompanies relapse and leads to progression of
the disease.
Chromos recently completed its first meeting with officials from the U.S.
Food and Drug Administration (FDA). The two parties discussed Chromos' clinical
approach, proposed preclinical safety evaluation program and manufacture of
CHR-1103. Chromos is now moving forward with preclinical safety evaluation
studies in preparation for an Investigational New Drug (IND) application in Q3
2007.
Using its proprietary ACE System, Chromos engineered a stable clonal cell
line expressing its product, CHR-1103 and transferred it to AppTec for process
development, scale up and manufacture. The ACE System demonstrated the ability
to perform well in large-scale manufacturing, validating the use of the
platform for clinical and commercial scale manufacturing of biopharmaceuticals.
The Company is now preparing to begin its preclinical safety evaluation studies
with Charles River Laboratories.
Chromos has engaged two leading MS clinicians to act as clinical
consultants for its CHR-1103 program. Lily Jung, M.D. is the Medical Director
of the Seattle Neuroscience Institute at Swedish Medical Centre in Seattle, WA,
and a clinical associate professor in Neurology at the University of Washington
Medical School. Mariko Kita, M.D. is a clinical investigator and Director of
the Virginia Mason Multiple Sclerosis Center in Seattle, WA. Drs. Jung and Kita
will advise and assist with the clinical development of CH"......

2006-08-14T19:15:00.000-07:00

(Cytoxan): High-Dose Cyclophosphamide(Cytoxan) for Moderate to Severe Refractory MS:
[Arch Neurol -- Abstract] "Conclusions: High-dose cyclophosphamide treatment in patients with severe refractory multiple sclerosis can result in disease stabilization, improved functionality, and improved quality of life. Further studies are necessary to determine the most appropriate patients for this treatment. "

2006-08-14T07:13:00.000-07:00

"interleukin 27 (IL-27)... ":
"Research May Bring New Hope for MS patients....A SIGNALLING molecule that seems to dampen inflammation may help scientists develop new treatments for MS. Two studies published in the journal Nature Immunology highlight the role of interleukin 27 (IL-27) in the brain. IL-27 is a protein belonging to a large family of molecules called cytokines which send signals between cells. Some cytokines are believed to trigger inappropriate immune system responses, resulting in inflammation and auto-immune diseases like MS. Two teams of scientists artificially induced MS-like reactions in the brains of mice......

2006-08-10T07:03:00.000-07:00

NeuroVax: Immune Response Corporation Receives $9.9 Million...Raising Aggregate $17.9 Million from 2006 Financing:
"Funding Will Support Continuation of Phase II Clinical Trials In MS. The Company's lead immune-based therapeutic product candidates are NeuroVax(TM) for the treatment of MS..."

2006-08-09T07:41:00.000-07:00

Cannabis-Based Pain Treatment: SATIVEX
"European authorities asked for two phase III trials of Sativex against neuropathic pain in the same patient group, Salisbury, England-based GW said today. Phase III is the last of three stages generally required for approval. Sativex was delayed by U.K. regulators in June 2005 and has yet to gain approval for spasticity, or stiffness and spasms in multiple-sclerosis patients. GW said in March that it may ask European regulators to approve the medicine before the U.K....``One of the principal purposes of this study is to complete the regulatory package required for the approval in Europe of Sativex in the indication of neuropathic pain in MS,'' said Stephen Wright, the company's head of research.

Sativex was delayed by U.K. regulators in June 2005 and has yet to gain approval for spasticity, or stiffness and spasms in multiple-sclerosis patients. GW said in March that it may ask European regulators to approve the medicine before the U.K.

Shares in GW fell 5.5 pence, or 6.1 percent, to 84.5 pence by 8:45 a.m. in London trading. They rose 17 percent yesterday and have fallen 44 percent this year.

Canadian regulators approved Sativex, administered as a mist sprayed inside the mouth, for use in neuropathic pain caused by nerve damage, in April 2005."

2006-08-09T07:27:00.000-07:00

SATIVEX: GW Pharmaceuticals :
"GW Pharmaceuticals Wednesday announces the start of a second pivotal Phase III trial in people with multiple sclerosis (MS) suffering from central neuropathic pain....This Phase III study is a double-blind randomised placebo-controlled study of Sativex in 218 patients with central neuropathic pain due to MS, who have achieved inadequate pain relief with existing therapies.....

2006-07-28T07:00:00.000-07:00

phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).:
"phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive MS (SPMS).

BioMS Medical is currently enrolling patients across Canada, the U.K., Sweden and Denmark in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every 6 months for a period of 2 years.

The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

To date the trial has successfully passed four safety reviews by its independent Data Safety Monitoring Board...".

"

2006-07-17T21:22:00.000-07:00

New Hope for Patients With Aggressive MS:
"A new combination treatment regime, for patients with aggressive forms of multiple sclerosis (MS), is offering new hope to a group of patients who would otherwise be at high risk of early disability according to British research due to be published in next month's Journal of Neurology August 2006 (currently available on line).

The treatment regime, consisting of a limited course of mitoxantrone (an immunosuppressant normally used to treat cancer) followed by long-term glatiramer acetate (Copaxone(R) - one of two classes of disease modifying drugs for use in relapsing-remitting multiple sclerosis), has proven so successful in this early trial that a full controlled study is now being initiated at 10 centres across the UK to examine the combination further. Investigators are now looking to enrol suitable patients with MS...."

2006-07-17T21:17:00.000-07:00

Elan (Tysabri) links with Archemix to develop MS drug:
"Drugmaker Elan will link up with Massachusetts-based biopharma company Archemix to develop therapeutic aptamers, or proteins that work like antibodies, to treat auto-immune diseases such as MS...."