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Monday
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
Saturday
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
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]
Monday
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]
"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]
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)....
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)....
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....
(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....
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."
"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."
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]
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]
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).....
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).....
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]
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]
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
[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
"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."...
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"
"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"
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...."
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....
"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....
>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]"
"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]"
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
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
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
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
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......
"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.....
"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.....
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....
¶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....
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."
"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."
"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.....
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."
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.
[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.
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:
Biogen's development pipeline for MS includes:
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.
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.".......
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.".......
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)....
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)....
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]
"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]
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)....
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)....
Sunday
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)....
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)....
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....
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....
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.
"
"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.
"
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.
"
"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.
"
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>
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>
Wednesday
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:
Biogen's development pipeline for MS includes:
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.
THIS PAGE IS UNDER CONSTRUCTION...SOME RECENT HEADLINES HAVE NOT BEEN TRANFERRED TO THIS NEW SITE
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
Monday
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."
"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."