Category Archives: MS Treatment

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced that the company has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of LEMTRADA (alemtuzumab) for treatment of relapsing multiple sclerosis (RMS). Genzyme is developing LEMTRADA in MS in collaboration with Bayer HealthCare. Genzymes clinical development program for LEMTRADA included two Phase III studies in which results for LEMTRADA were superior to Rebif (high dose subcutaneous interferon beta-1a) on clinical and imaging endpoints, including a reduction in relapse rate. In addition, as presented last month at the American Academy of Neurology meeting, some patients with pre-existing disability treated with LEMTRADA in the CARE-MS II trial were more than twice as likely to experience a sustained reduction in disability over two years than patients treated with Rebif. There remains a large unmet treatment need for patients living with active disease and we believe that LEMTRADA, given its efficacy and unique dosing schedule, has the potential to transform the lives of patients with MS, said Genzyme President and CEO, David Meeker. The regulatory submissions for LEMTRADA include … Continue reading →

(RTTNews.com) - Swiss drugmaker Novartis AG (NVS) on Monday said a new data for multiple sclerosis drug Gilenya (fingolimod) showed long-term efficacy benefit and a consistent safety profile. Gilenya, licensed from Japan'sMitsubishi Tanabe Pharma Corp., is the only oral therapy approved to treat people with relapsing forms of multiple sclerosis. The data from single-arm extension of phase III head-to-head TRANSFORMS study showed sustained reduction in relapses and rate of brain volume loss in patients on continuous Gilenya treatment for up to 4.5 years, the company noted The results also showed improved efficacy for patients switched to Gilenya from Avonex (interferon-beta-1a IM), a commonly prescribed MS treatment from Biogen Idec Inc. (BIIB). Novartis noted that reductions in relapses and MRI measures were observed in these patients. In the core TRANSFORMS study, Gilenya demonstrated superior efficacy to Avonex, reducing the annualized relapse rate by 52% at one year. The extension study showed that this low relapse rate was sustained in patients receiving continuous treatment with Gilenya for up to 4.5 years. As per the study results, patients treated with Gilenya continuously maintained a low brain atrophy rate throughout the study as measured by assessing brain volume loss, which is valued as a … Continue reading →

CNW Group/Novartis Pharmaceuticals Canada Inc. Caitlin Cronenbergis a young photographer who has made a name for herself chronicling fashion and celebrityas well as the cinematic process of her filmmaker father, David Cronenberg. So a press release issued last week headlined Caitlin Cronenberg Exposes the Reality of Young Women Living with MS appeared to signal a boldeven bravedeparture for her. Multiple sclerosis, or MS, is a chronic degenerative condition that can lead to paralysis, depression, and blindness. Its a mysterious condition; progression varies radically; its cause is unknown. Nobody even knows how many Canadians have it: the much-repeated statistic of 50,000 to 75,000 people is out of date, an MS Society of Canada spokesperson told me months ago. It doesnt lend to easy imagery. So I wondered: Is Cronenberg now delving into the dark, uncomfortable territory annexed so well by her dad? But the reality that Cronenbergs one-night exhibit, DREAM/AWAKE, exposes is less about MS than about how a pharmaceutical giant can create buzz amid advertising restrictionsin this case, by linking a fashionable female photographer to a prescription drug targeted at young women. Thats whom multiple sclerosis strikes mostthree times more frequently than men. Cronenberg was hired for the gig a … Continue reading →

Patients who underwent the so-called liberation treatment for multiple sclerosis experienced no measurable benefit from the procedure, a study commissioned by the government of Newfoundland and Labrador found. The results of the small, observational study were announced in St. John's by lead investigator Dr. William Pryse-Phillips, a professor emeritus of neurology at Newfoundland's Memorial University. Pryse-Phillips said he had gone into the study hopeful the treatment might have something to offer his MS patients, but completed it convinced the people who had the vein-opening procedure didn't experience any gains. "I am disappointed. I had hoped. I cannot recommend this therapy on the basis of these results at this time," he said during a news conference on Wednesday, the video of which is posted on the Department of Health and Community Service's website. The province spent $400,000 on the study, which compared 30 patients with MS who had travelled outside the province to have the therapy and 10 who did not. Participants were subjected to an array of tests before the treatment and then at intervals of one month, three months, six months and one year post-procedure. Saskatchewan's government is spending $2.2 million to help fund an Albany, N.Y.-based clinical trial … Continue reading →

TORONTO A new study says patients who underwent the so-called liberation treatment for multiple sclerosis experienced no measurable benefit from the procedure. The government of Newfoundland and Labrador, which funded the study, announced the findings Thursday in St. Johns. The government said based on the findings, the province will not cover the cost of liberation treatment. The study was small, including 30 participants who got the procedure and 10 who did not. The researchers did not know which were which as they assessed the patients. Participants were subjected to a series of physical and cognitive tests at the start of the study and then at one, three, six and 12 months after receiving the treatment. The researchers saw no measurable benefits, though patients themselves reported feeling better. The controversial liberation treatment is based on a theory that MS is a disease caused by blocked veins, not a neurodegenerative disease as is currently thought. The theory, advanced by Italian Dr. Paolo Zamboni, is that in MS patients, veins in the neck and upper chest develop blockages which restrict blood flow from the brain. According to the theory, the blockages lead to a pooling of iron-rich blood in the brain that triggers … Continue reading →

Date: Thursday Jun. 7, 2012 7:03 PM ET TORONTO Patients who underwent the so-called liberation treatment for multiple sclerosis experienced no measurable benefit from the procedure, a study commissioned by the government of Newfoundland and Labrador found. The results of the small, observational study were announced Wednesday in St. John's by lead investigator Dr. William Pryse-Phillips, a professor emeritus of neurology at Newfoundland's Memorial University. Pryse-Phillips said he had gone into the study hopeful the treatment might have something to offer his MS patients, but completed it convinced the people who had the vein-opening procedure didn't experience any gains. "I am disappointed. I had hoped. I cannot recommend this therapy on the basis of these results at this time," he said during a news conference, the video of which is posted on the Department of Health and Community Service's website. The province spent $400,000 on the study, which compared 30 patients with MS who had travelled outside the province to have the therapy and 10 who did not. Participants were subjected to an array of tests before the treatment and then at intervals of one month, three months, six months and one year post-procedure. It was an attempt to test … Continue reading →

TORONTO Patients who underwent the so-called liberation treatment for multiple sclerosis experienced no measurable benefit from the procedure, a study commissioned by the government of Newfoundland and Labrador found. The results of the small, observational study were announced Wednesday in St. Johns by lead investigator Dr. William Pryse-Phillips, a professor emeritus of neurology at Newfoundlands Memorial University. Pryse-Phillips said he had gone into the study hopeful the treatment might have something to offer his MS patients, but completed it convinced the people who had the vein-opening procedure didnt experience any gains. I am disappointed. I had hoped. I cannot recommend this therapy on the basis of these results at this time, he said during a news conference, the video of which is posted on the Department of Health and Community Services website. The province spent $400,000 on the study, which compared 30 patients with MS who had travelled outside the province to have the therapy and 10 who did not. Participants were subjected to an array of tests before the treatment and then at intervals of one month, three months, six months and one year post-procedure. It was an attempt to test a theory that has driven a wedge between … Continue reading →

EXTON, Pa.--(BUSINESS WIRE)-- BioTrends Research Group, one of the worlds leading research and advisory firms for specialized biopharmaceutical issues, finds through analysis of U.S. longitudinal patient-level claims data that patient share of Novartiss Gilenya has increased in both newly diagnosed and recently treated multiple sclerosis (MS) patients. The recently treated patient group represents patients treated in the third quarter of 2011 and reviews historical therapies used in their treatment. According to Treatment Algorithms in Multiple Sclerosis, more than three quarters of switches to Gilenya in recently treated patients in the third quarter of 2011 came from patients who had previously taken an interferon-beta or Tevas Copaxone. A much smaller percentage of drug switches to Gilenya came from patients who had previously taken Biogen Idec/Elans Tysabri. Until the launch of Gilenya, Tysabri offered one of the few options for patients whose disease had progressed past the point where it could be effectively managed with interferon-betas or Copaxone, said BioTrends Director Nicole Westphal, Ph.D. Gilenyas oral formulation is likely a key driver of its use in recently treated MS patients following treatment with an interferon-beta or Copaxone. Additionally, physicians may be increasingly turning to Gilenya for MS patients who require stronger disease … Continue reading →

An observational study of people in Newfoundland and Labrador who had a controversial treatment for multiple sclerosis found there was no measurable benefit to the Zamboni procedure, according to the neurologist who led the research. "I cannot recommend this treatment to MS patients," said Dr. William Pryse-Phillips, a neurologist and the lead researcher of the study. The province launched the study of what is known as the Zamboni procedure, or liberation therapy, nearly two years ago after people from this province travelled abroad to undergo the experimental procedure. It's based on a theory that MS is linked to blocked veins in the neck, and that opening them up helps relieve symptoms of the debilitating disease. Mark Lane, who lives with MS and paid $4,000 to have procedure done in Poland almost two years ago, was at the announcement about the study's findings in St. John's on Thursday. "I'm disappointed by these findings. We all had hope," Lane, 36, said. "I know it's not a cure, but I still believe despite this that there is a link and I'm getting [the procedure] again if I start to deteriorate." The province spent more than $400,000 for the study after intense lobbying from … Continue reading →

Multiple sclerosis is a debilitating, often deadly disease that attacks the body's central nervous system. It can devastate a victim's brain, spinal cord, optic nerves and vision. The disease is unpredictable. While treatments and medication currently on the market can help slow down the attacks, there is no cure. Yet. But the cure for MS just might be sitting right in southeastern Wisconsin's backyard. Endece LLC, a Mequon-based drug discovery company, recently formed Endece Neural, a subsidiary company focused on neurological drug development. More specifically, Endece Neural is pursing the development of a drug that could help repair and even reverse the damage caused by MS. Endece's work is getting some attention in the world of MS research. "We're very excited about the Endece compounds," said Jay Tung, president of drug discovery at the Myelin Repair Foundation in San Francisco. Endece hopes to collect enough data so the U.S. Food and Drug Administration will accelerate clinical testing enough to have the drug on the market in five to seven years. "We've already proven that our compound and even our backup compounds work in in vitro (in Petri dish) environments," said James Yarger, chief executive officer of Endece. The central nervous … Continue reading →