Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing Tcelna ®, a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS), today announced that Don Healey, Ph.D., Opexa’s Chief Scientific Officer, has been invited as a guest speaker to participate in the Phacilitate Cell & Gene Therapy Forum. The event will take place January 27-29, 2014, at The Grand Hyatt in Washington, DC. Dr. Healey will discuss the design and value of potency assays to render them more relevant to cell and gene therapy and more appropriate to clinical practice/benefit, during the focus session, " Process Standardization and Comparability - Do We Need a Rethink?" Dr. Healey's presentation, entitled, " Individual Lots of Autologous Product, All the Same but Different: The Potency Conundrum" will take place on Monday, January 27th at 12pm EST. The Phacilitate Cell & Gene Therapy Forum is the preeminent industry led meeting place pushing the maturation of regulatory, manufacturing, R&D and commercial strategies. About Opexa Opexa’s mission is to lead the field of Precision Immunotherapy™ by aligning the interests of patients, employees and shareholders. The Company’s leading therapy candidate, Tcelna ®, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of SPMS. Tcelna is derived from T-cells isolated from a patient’s peripheral blood, expanded ex vivo, and reintroduced into the patient via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin. About Multiple Sclerosis (MS) MS is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. The secondary progressive form of MS represents about a third of the MS patient population.
About TcelnaTcelna ® is a potential personalized therapy that is under development to be specifically tailored to each patient's disease profile. Tcelna is manufactured using ImmPath ®, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response. Opexa is currently conducting a Phase IIb study of Tcelna. Named “Abili-T,” the trial is a randomized, double-blind, placebo-controlled clinical study in patients who demonstrate evidence of disease progression with or without associated relapses. The trial is expected to enroll 180 patients at approximately 30 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trial’s primary efficacy outcome is the percentage of brain volume change (atrophy) at 24 months. Study investigators will also measure several important secondary outcomes commonly associated with MS, including disease progression as measured by the Expanded Disability Status Scale (EDSS), annualized relapse rate and changes in disability as measured by EDSS and the MS Functional Composite. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com.