Category Archives: MS Treatment

(RTTNews.com) - The U.S. Food and Drug Administration Wednesday approved Sanofi's (SNY) multiple sclerosis drug Aubagio as a once daily tablet for the treatment of adults with relapsing forms of the disease. In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo. The drug contains a Boxed Warning to the risk of liver problems, including death, and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment. Also included in the Boxed Warning is an alert noting that the drug may cause fetal harm. The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss. Multiple Sclerosis, or MS, is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by … Continue reading →

By Jennifer Corbett Dooren WASHINGTON--The U.S. Food and Drug Administration Wednesday approved a Sanofi SA (SNY, SAN.FR) pill to treat multiple sclerosis, making it the second oral therapy that will be available on the U.S. market. The drug, teriflunomide, will be sold with the brand name Aubagio to treat people with the relapsing remitting form of MS. Multiple sclerosis is a progressive disease that involves damage to nerves controlling muscles and vision; it affects about 400,000 Americans and 2.5 million people world-wide. The condition causes the body's immune system to eat away at the protective covering of the nerves, or myelin, which disrupts the electrical signals between the brain and the rest of the body. Most MS patients are of the "relapsing- remitting" type, where the disease flares up periodically and largely disappears for long periods of time. Aubagio will compete with Novartis AG's (NVS) oral pill Gilenya, which was approved by the FDA in 2010 and has been available in Europe since 2011. FDA said a clinical trial showed the relapse rate for patients using Aubagio was about 30% lower than the rate for those taking a placebo, or sugar pill. The product was approved with FDA's strictest boxed … Continue reading →

FDA NEWS RELEASE For Immediate Release: Sept. 12, 2012 Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA approves new multiple sclerosis treatment Aubagio The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS). In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo, said Russell Katz, M.D., director of the Division of Neurology Products in the FDAs Center for Drug Evaluation and Research. Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients. MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline. The most common side effects of Aubagio … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved AUBAGIO (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). AUBAGIO has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI. We are very excited to introduce AUBAGIO as a new treatment option that can make a difference in the lives of people with multiple sclerosis, said David Meeker, President and CEO, Genzyme. The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community. The FDA approval was based on efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. In the Phase III TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with relapsing forms of multiple sclerosis. AUBAGIO 7 mg significantly reduced the annualized relapse rate (p=0.0002) in the trial. Many people living … Continue reading →

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tcelna, a novel T-cell therapy for multiple sclerosis (MS), today announced the initiation of a Phase IIb clinical trial of Tcelna in patients with Secondary Progressive Multiple Sclerosis (SPMS). Several patients have already been enrolled in the study and enrollment is expected to increase rapidly as additional sites begin screening and enrolling patients in the coming weeks. Tcelna is the first ever personalized T-cell therapy for MS patients and has received Fast Track Designation from the United States Food and Drug Administration (FDA) for the treatment of SPMS. The therapy is specifically tailored to each patients individual disease profile and has demonstrated superior safety and encouraging indications of efficacy in previous clinical studies in MS that included the treatment of SPMS patients. There is currently only one FDA-approved treatment for SPMS but safety warnings have severely restricted its use. While a positive trial outcome will certainly be good news for SPMS patients, it is also not difficult to envision that it could position Tcelna as a promising treatment for the larger RRMS patient population as well. The newly initiated trial, named Abili-T, is a randomized, double-blind, placebo-controlled clinical study in … Continue reading →

The Universitys Brain Health Institute is expanding research on the treatment of brain disorders thanks to Cheryl Dreyfus, a leading multiple sclerosis researcher. Dreyfus, professor and chair of the Department of Neuroscience and Cell Biology at Robert Wood Johnson Medical School, said since she began working on models of the disease in tissue cultures, she hoped to approach a treatment for the autoimmune disease that affects about 350,000 people in the United States. We really dont know well what MS is, but were finding growth factors that affect cells in development can also affect those cells that are dying in MS [patients], she said. Dreyfus said her lab team is examining a protein called brain-derived neurotrophic factor (BDNF), which can help create new brain cells and prevent existing ones from dying. In patients with MS, the myelin sheath, or protective covering that insulates brain cells, disintegrates, Dreyfus said, leading to symptoms ranging from muscle spasms and difficulty speaking to visual impairment and depression. Many treatments for MS deal with treating inflammation that occurs when the sheath around the brain cells diminishes, Dreyfus said. But her labs approach to finding a treatment focuses on recovering brain function, she said. Her partnership … Continue reading →

ScienceDaily (Sep. 11, 2012) A research study conducted by Dr. Jesus Lovera, Assistant Professor of Neurology at LSU Health Sciences Center New Orleans, and colleagues has found that the herbal supplement Ginkgo biloba does not improve cognitive function in patients with Multiple Sclerosis (MS.) Cognitive impairment affects 40-60% of people with MS, most commonly affecting their processing speed, memory, and executive skills. The research findings were published online ahead of print in Neurology on Sept. 5, 2012. This study followed up on a promising earlier small study by Dr. Lovera and his colleagues that had shown improvement in cognitive function with Ginkgo biloba in people with MS. Some studies have also shown improvement after treatment with Ginkgo biloba in people with Alzheimer's disease. "Ginkgo biloba supplements are frequently used by people with MS. Ginkgo appeared beneficial in a prior small pilot study we had done," said Dr. Jesus Lovera, a neurologist at LSU Health Sciences Center New Orleans who specializes in MS. The researchers wanted to conduct a larger more robust study to determine the validity of the preliminary results. One hundred twenty people with MS were randomized to either the group treated with 120 mg of Ginkgo biloba twice … Continue reading →

Public release date: 11-Sep-2012 [ | E-mail | Share ] Contact: Leslie Capo lcapo@lsuhsc.edu 504-568-4806 Louisiana State University Health Sciences Center New Orleans, LA A research study conducted by Dr. Jesus Lovera, Assistant Professor of Neurology at LSU Health Sciences Center New Orleans, and colleagues has found that the herbal supplement Ginkgo biloba does not improve cognitive function in patients with Multiple Sclerosis (MS.) Cognitive impairment affects 40-60% of people with MS, most commonly affecting their processing speed, memory, and executive skills. The research findings were published online ahead of print in Neurology on September 5, 2012. This study followed up on a promising earlier small study by Dr. Lovera and his colleagues that had shown improvement in cognitive function with Ginkgo biloba in people with MS. Some studies have also shown improvement after treatment with Ginkgo biloba in people with Alzheimer's disease. "Ginkgo biloba supplements are frequently used by people with MS. Ginkgo appeared beneficial in a prior small pilot study we had done," said Dr. Jesus Lovera, a neurologist at LSU Health Sciences Center New Orleans who specializes in MS. The researchers wanted to conduct a larger more robust study to determine the validity of the preliminary results. … Continue reading →

By: Joleene DesRosiers Moody OSWEGO, NY Larry Lombardo has been in business for 25 years. A week after Bridie Manor opened its doors, Lombardo was diagnosed with a chronic, progressive disease that affects the central nervous system, brain, spinal cord and optic nerves: Multiple Sclerosis. Larry Lombardo beats the odds every day. He plays piano regularly. Now hes ready to celebrate a dual milestone that has more than opened his eyes to a world where blood, sweat and tears are much more than a metaphor. Im 58-years-old and Ive had MS for over two decades, he said. Ive owned this place just as long. What better way to celebrate our anniversary together than educating people in our community about this disease? Weve reached out to Multiple Sclerosis Resources of New York to help us with a fundraiser that will do just that. Multiple Sclerosis Resources of New York of East Syracuse has teamed up with OswegoCountyToday.com to spearhead the event. On Saturday, October 6, close to 250 people are expected to take part in a Poker Run. Participating business are: Thrifty Shopper The Press Box Murdocks Bicycles and Sports Cider Moon Coffee and Caf Marias Family Restaurant Harbor Towne Gifts … Continue reading →

THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (OPXA), a company developing Tcelna, a novel T-cell therapy for multiple sclerosis (MS), today announced that Neil Warma, President and Chief Executive Officer, will participate in two upcoming industry conferences. Details regarding these events are as follows: Intellectual Property Owners Association (IPO) Annual Meeting This conference will take place September 9-11, 2012 at the JW Marriott Hill Country in San Antonio, Texas. Each year, the organizers of the IPO Annual Meeting invite one CEO to deliver a keynote luncheon address. This year, Mr. Warma has been selected to provide insight on the role of intellectual property rights from the perspective of business. The 8thAnnual Burrill Personalized Medicine Meeting This meeting of researchers, drug developers, analysts, investors and other life science industry representatives will take place September 13-14, 2012 at the Bentley Reserve & Conference Center in San Francisco. Mr. Warma will join several additional panelists as they discuss the implications that advances in personalized medicine are having on the drug development business. Mr. Warma will share Opexas experiences regarding the clinical development of Tcelna, the first ever personalized T-cell therapy for MS patients. About Opexa Opexa Therapeutics, Inc. is dedicated to the development … Continue reading →