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."

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.

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.

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."

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

"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

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.

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

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.

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

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."

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

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.

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

"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

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

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."