THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (NASDAQ: OPXA - News), a biotechnology company developing Tovaxin, a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company will be holding a preliminary meeting with prospective clinical trial investigators at the 64th Annual American Academy of Neurology (AAN) Meeting in New Orleans on April 24, 2012. The purpose of this meeting will be to discuss the upcoming Phase IIb clinical trial using Opexas T-cell therapy in patients with Secondary Progressive Multiple Sclerosis (SPMS). "We are honored to introduce our next clinical trial to a group of invited neurologists at this years AAN meeting in New Orleans, commented Neil K. Warma, President and Chief Executive Officer of Opexa. The meeting will be an opportunity to discuss with select clinicians and their study coordinators potential participation in the SPMS clinical trial as well as present the final protocol for the trial including the design, structure and patient selection criteria. This is an exciting time for Opexa, neurologists and SPMS patients as this study will provide an innovative opportunity for treatment in an area where currently there are very few treatment options. The annual AAN meeting is an excellent forum for the … Continue reading →

Updated Gilenya label provides further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients in the United States Prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment Update to label marks the conclusion of discussions initiated in December 2011 Basel, April 20, 2012 - Novartis announced today agreement with the US Food and Drug Administration (FDA) on label changes for Gilenya (fingolimod). The update to the Gilenya prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment and more specific recommendations for treatment initiation for patients with relapsing forms of MS in the United States. The update marks the conclusion of discussions initiated in December 2011. The updated FDA label for Gilenya indicates that all patients initiating treatment with Gilenya should have an electrocardiogram (ECG) prior to the first dose of the medicine and after the six-hour first-dose observationperiod in addition to hourly measurement of blood pressure and heart rate. Additionally, specific initiation guidance for patients is now provided to better aid healthcare providers. Further, there are revised recommendations on how to re-initiate therapy should Gilenya be interrupted. As of February 2012, approximately 36,000 … Continue reading →

Organizers of Marshall's eighth annual Multiple Sclerosis Walk meet at Mexico Lindo in preparation of the event Thursday, April 12. Pictured from left to right are: (front row) Lyle Pointer, Brenda Coffman and Leslie Coslet; and (back row) Donna Lovell, Mo Fowler, Jason Coffman, lead organizer Tracy Coffman and event chairman Brian Lovell. (Sarah Reed/Democrat-News) In Marshall, people are ready to support research and to find better treatments for Multiple Sclerosis. In its eighth year, organizers are hoping the MS Walk sees the same community support it has in the past. "I think everybody fights diseases in their own way, and this is the way we've all decided to help fight this ... to walk," said Donna Lovell. Started after organizer Tracy Coffman began walking for a cure in Sedalia, the Marshall MS Team was launched to support local residents with MS. Coffman was lucky in that she had symptoms of MS for less than a year before it was detected. Many go years without knowing. "There are so many different degrees," she said. "Things change from day to day." Approximately 400,000 Americans have been diagnosed with MS, according to the National Multiple Sclerosis Society. The central nervous system disease … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that 12 data presentations, including six platform presentations, from the companys multiple sclerosis (MS) clinical trial programs for alemtuzumab and teriflunomide will be featured at the American Academy of Neurology's (AAN) 64th Annual Meeting in New Orleans, La., April 21-28. Presentations will include full data results from CARE-MS II (The Comparison of alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a Phase III trial investigating alemtuzumab in MS patients who had relapsed while receiving prior MS therapy, as well as new findings from the teriflunomide clinical program, one of the largest and broadest of any MS therapy in development. Genzymes robust development programs for alemtuzumab and teriflunomide were designed to understand how these therapies can best address significant unmet medical needs of people living with MS, said David Meeker, M.D., President and CEO, Genzyme. We are committed to becoming a long-term partner to the MS community with the goal of raising the expectation of what life with MS can be. Marketing applications for teriflunomide for the treatment of relapsing forms of MS are under review by the U.S. Food & Drug Administration (FDA) and European Medicines Agency … Continue reading →

* EU review concludes Gilenya benefits outweigh its risks * EMA and FDA back stronger warnings for heart-risk patients * Novartis still sees drug as "blockbuster" (Adds U.S. label changes) LONDON, April 20 (Reuters) - European and U.S. regulators have backed the continued use of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, but said on Friday the drug needed to carry stronger warnings on heart risks. Novartis said the decision meant the drug remained on-track to be a "blockbuster" - one with annual sales above $1 billion. Prospects for Gilenya, the first multiple sclerosis (MS) pill of its kind, have been clouded by reports of its association with serious heart problems. The European Medicines Agency (EMA), which launched a review into the safety of Gilenya in January, said doctors should not prescribe it to patients with a history of cardiovascular and cerebrovascular disease or those on heart-rate lowering medication. If treatment with Gilenya was considered necessary in these patients, however, their heart activity should be monitored at least overnight following the first dose of the drug, it said. All patients getting the drug should have an electrocardiogram (ECG) and a blood pressure … Continue reading →

Early use of the multiple sclerosis drug interferon beta-1a might slow and even stop progression of the disease, according to new research from the American Academy of Neurology. Patients who received interferon soon after their first disease symptoms were less likely to see the disease progress into "clinically definite" multiple sclerosis, which is categorized as having had two separate attacks along with two separate lesions. Multiple sclerosis is an autoimmune disease that affects the brain and spinal cord. The disease attacks the myelin sheath, a protective covering that surrounds nerve cells. The disease is degenerative, and symptoms can vary. Patients suffer attacks that can last days, weeks or months. Symptoms affect the muscles, bowel function, vision, numbness, sexual function and personality. "While we've known it's beneficial to start MS drugs as soon as possible, this is the first trial to show a benefit of early injections of interferon beta-1a treatment at three years," Dr. Mark Freedman of the University of Ottawa in Ontario and a fellow of the American Academy of Neurology said in a statement. The three-year trial involved 517 people who had experienced their first MS symptoms, which includes tingling, numbness, muscle weakness or balance problems. The participants … Continue reading →

Canada's Health Minister Leona Aglukkaq announced Wednesday that the federal government will fund a clinical trial for "liberation treatment," an experimental vein therapy for multiple sclerosis developed by an Italian doctor. The MS Society of Canada, a co-funding partner of the project, said it's "thrilled" by the announcement that may bring "definitive answers" about the controversial treatment developed by Dr. Paolo Zamboni. The clinical trial for Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Canadians with multiple sclerosis seeks to determine the safety of venous angioplasty, also known as "liberation treatment" which requires the opening of blocked veins, the Canadian Institutes for Health Research said in a release about the announcement. Liberation treatment rejects long-held medical opinion that MS is an autoimmune disease. At least two Canadians have reportedly died overseas from complications of the procedure, which is currently unavailable in Canada. Asked about the controversy surrounding the procedure, MS Society of Canada CEO Yves Savoie said he supports the call of those concerned about the treatment for more rigorous research. "We're thrilled at this very important step and because of this question of the risk, that's why there are appropriate safeguards for participants going to be involved in that, including an … Continue reading →