“We are pleased to extend our range of devices with RebiDose(TM) to meet the needs of patients looking for simple and minimum injection preparation,” said Roberto Gradnik, Head of Global Business Unit Neurodegenerative Diseases at Merck Serono. “The introduction of RebiDose(TM), alongside RebiSmart(TM), which was launched last year, underscores our commitment to improve the treatment convenience of multiple sclerosis patients, by offering them different options to suit their individual injection needs.”

Patients on Campath had an annualized relapse rate of 0.11, while for those getting Rebif the rate was 0.35 at the end of five years, according to data presented today at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Sweden. Campath is currently used to treat a type of blood cancer.

The Phase 2 trial compared alemtuzumab to an approved multiple sclerosis therapy Rebif in early, relapsing-remitting multiple sclerosis or RRMS patients who had received no prior therapy. Three-year trial data were reported in the New England Journal of Medicine in last October.

In the trial, alemtuzumab was given to patients in two or three annual cycles of not more than five days per cycle, while Rebif was given to patients three-times per week, every week for three years.

The four-year analysis of early RRMS patients from the trial found that patients taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 72% and the risk of sustained accumulation of disability by 73% compared to patients treated with the active comparator Rebif. These data closely mirror the three-year findings reported in the NEJM manuscript. Further, the annualized relapse rate and disability risk measured from year three to four remained at the same low level observed in prior years of the study.

View entire post here: http://www.rttnews.com/Content/BreakingNews.aspx?Node=B1&Id=1064498%20&Category=Breaking%20News

Teriflunomide, which was used as an add-on therapy to interferon beta in the Phase II clinical trial, is one of a number of MS drugs in development that are designed to be given by mouth rather than injection or infusion.

In the 24-week study, patients on the new drug experienced a 56 percent and 81 percent reduction in cerebral inflammatory lesions compared to those on placebo, as measured by MRI scan, on two different doses of the drug, which was well tolerated.

“These results encourage longer-term studies to establish the clinical benefit of combination treatment in this disease where effective new therapies are eagerly awaited,” investigator Mark Freedman of the University of Ottawa said in a statement.

Teriflunomide is currently being evaluated in final-stage Phase III studies.

Shares in Sanofi were 1.6 percent higher by 1415 GMT, also buoyed by news of a U.S. patent victory for its cancer drug Eloxatin. [ID:nnLB675736]

Oral treatments are seen as an important advance in the treatment of multiple sclerosis, a chronic and degenerative neurological disease, and are being pursued by several companies.

The most advanced product is Merck KGaA’s cladribine, which also reported encouraging clinical trial results on Friday. [ID:nLB553376]

The data on teriflunomide and cladribine was presented at the European Committee for Treatment and Research in Multiple Sclerosis congress in Duesseldorf.

(Reporting by Ben Hirschler; editing by John Stonestreet)

View entire post here: http://www.reuters.com/article/rbssHealthcareNews/idUSLB2129720090911

“This study showed that treatment with AVONEX leads to fewer injection site reactions which is an important factor in improving compliance. As the only once-weekly injection treatment, AVONEX offers people with relapsing MS an easy-to-use and highly effective treatment option,” said Dr. Karsten Beer, lead investigator for the study and private neurologist in Wil, Switzerland. “Convenience of an MS therapy is an important consideration for patients, as they do not want a therapy that will interfere with their daily lives.”

The Swiss MS Skin Project was designed to determine the frequency of injection site reactions, including skin necrosis and lipoatrophy, in patients taking AVONEX, Betaferon, Copaxone, or Rebif (ABCRs). These data are important as ISRs are thought to reduce treatment compliance among patients. The study enrolled nearly 500 patients on ABCRs for a minimum of two years (mean treatment duration of 5.9 years) and followed patients for a total of one year. Study findings include:
- At the first assessment, significantly fewer AVONEX patients experienced ISRs (13.4% vs 57.7% for Betaferon [p < .0001], 30.4% for Copaxone [p = 0.056], 67.9% for Rebif [p < 0.001]), necrosis (0.0% vs 5.7% for Betaferon [p = 0.0279],  0.0% for Copaxone [p = NS], 6.0% for Rebif [p = 0.0201]) and lipoatrophy (1.2 % vs 8.9% for Betaferon [p = 0.0210], 13.0% for Copaxone [p = 0.0322], 10.3% for Rebif [p = 0.0093]);
- No AVONEX patients missed a dose in the four weeks prior to first assessment due to ISRs (vs 5.7% for Betaferon [p = 0.44], 4.3% for Copaxone [p = NS], and 7.1% for Rebif [p = 0.011]). These percentages were statistically significant versus Betaferon and Rebif; and
- Significantly more patients remained on AVONEX over the one year trial (86.6% vs 79.7% for Betaferon, 60.9% for Copaxone, and 83.2% for Rebif [overall p = 0.0364]) than any other treatment.

View full post here: http://www.eurekalert.org/pub_releases/2009-09/msl-fis091009.php

These data show that over two years of study, 43% and 44% of patients treated with Cladribine Tablets (total dose of 3.5 mg/kg and 5.25 mg/kg respectively) had absence of disease activity, compared with 16% of patients who received placebo (p<0.001 for both Cladribine Tablets groups). Disease activity was assessed both clinically and radiologically and absence of disease activity was stringently defined as no relapses, no sustained disability progression, no T1 gadolinium-enhancing lesions and no active T2 lesions based on magnetic resonance imaging (MRI) during the study.
“Immune-mediated disorders such as relapsing forms of multiple sclerosis are characterized by periods of disease activity alternating with periods of remission, and a very important goal in treating such disorders is to help patients achieve and maintain disease remission for longer periods of time,” said Dr. Peter Rieckmann, Professor of Neurology, Director Department of Neurology, Bamberg Hospital, Germany, UBC Research Chair Vancouver/Canada and an investigator in the CLARITY study. “This CLARITY data analysis is very encouraging, based on the comparison between short-course oral treatment with Cladribine Tablets and placebo with respect to MS patients who had no disease activity, as assessed by both clinical and radiological measures over two years, with only 8-20 days of treatment in the first year of study and only 8-10 days of treatment in the second year of study.”

View entire post here: http://www.drugs.com/clinical_trials/new-data-clarity-study-activity-ms-patients-received-cladribine-presented-25th-ectrims-congress-8030.html

It’s estimated that at least 65% of Multiple Sclerosis patients endure cognition problems on a day to day basis. Challenges with multi-tasking, memory attention, executive functioning, information processing, learning, and visuospatial abilities are common and can negatively impact quality of life and stress levels.

The BCM doctors set out to understand whether using computer-assisted cognitive rehabilitation (CACR) would help patients with mild to moderate cognitive impairment. After 18 weeks of using computer assisted rehabilitation, the twelve individuals enrolled in the trial, showed improvement between 19-38 percentile points in the various cognitive areas. That’s exciting news when you are struggling to learn a new task, follow a recipe, remember your own family’s names, or how to do simple math in your head.

Finding sites that offer free brain fitness exercises online isn’t too difficult. So, go ahead and start exercising your brain today. You have everything to gain.

View full article here: http://www.examiner.com/x-22318-Houston-Multiple-Sclerosis-Examiner~y2009m8d31-Increasing-cognition-by-playing-games

CAMBRIDGE, Mass., Aug. 25 /PRNewswire/ — Peptimmune, Inc., a privately held biotechnology company, announced the completion of a clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301 in subjects with Secondary Progressive Multiple Sclerosis (SP-MS). PI-2301 is a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

The Phase Ib multiple-ascending dose, double-blind, placebo-controlled, randomized study enrolled 50 subjects with SP-MS. A total of 36 subjects received PI-2301 once weekly for 8 weeks followed by an open label extension of an additional 4 weeks. The doses ranged from 1 to 60 mg. Safety at all doses, including potentially therapeutic doses, was established. The most frequent adverse events (AEs) were dose-dependent site reactions which were mild to moderate, transient, and resolved without specific therapy. Dose-dependent increases in serum levels of anti-inflammatory markers were consistent with PI-2301 exposure as measured using the Company’s proprietary pharmacokinetic assay. The Company plans to continue developing this promising compound by initiating a Phase II study in multiple sclerosis patients later this year.

“PI-2301 has now shown safety and pharmacologic activity in two clinical studies, the first in healthy volunteers, and this second in patients with multiple sclerosis. As we look forward to the Phase II, we are excited about the observed pharmacologic effects of PI-2301 in patients suffering from secondary progressive MS,” stated Thomas P. Mathers, President and CEO of Peptimmune.

Data from this Phase Ib study will be presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Dr. Eric Zanelli will make a poster presentation titled “Clinical and biological results of a 12-week, double-blind, multiple ascending dose study evaluating the safety and tolerability of peptide copolymer PI-2301 in patients with the secondary progressive form of multiple sclerosis.” The poster (P-422) will be presented within Topic 15 – Immunomodulation – 1 during the Poster Session I taking place on Thursday, September 10, 2009, between 2:30 and 5:00 p.m.

About PI-2301

PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in autoimmune diseases such as multiple sclerosis. PI-2301 has been optimized using Peptimmune’s novel platform peptide chemistry and, in preclinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis and other autoimmune diseases where immune modulation may be effective, such as Crohn’s disease, rheumatoid arthritis, and autoimmune uveitis. Peptimmune has high-quality synthesis and analytical methods that provide a superior level of batch-to-batch reproducibility in the manufacturing of PI-2301.

View full article here: http://www.drugs.com/clinical_trials/peptimmune-completes-phase-ib-study-pi-2301-multiple-sclerosis-patients-presentation-ectrims-2009-7950.html