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Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing Tcelna
® (imilecleucel-T), a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS), today announced its participation at the American Academy of Neurology (AAN) 2014 Annual Meeting taking place from April 26 to May 3, 2014 in Philadelphia. The AAN Annual Meeting is the world’s largest gathering of neurologists, featuring breakthrough scientific research.
Opexa is sponsoring a booth at the AAN at which the leadership team will be present to discuss Tcelna, its lead therapy, which is currently in development for the treatment of Secondary Progressive Multiple Sclerosis (SPMS). Presentations and discussions on the Abili-T clinical trial, mechanism of action of Tcelna and key points of differentiation will be discussed.
Opexa is also planning to hold a meeting of Abili-T clinical trial investigators to review the status of the ongoing Phase IIb Abili-T trial in SPMS. This is a planned meeting and will include neurologists and study coordinators from several of the clinical sites.
Additionally, Opexa is hosting a reception for investors and analysts to discuss SPMS, and how a targeted, personalized therapy may be effective in addressing this unmet medical need. Two key opinion leaders, Professor Hans-Peter Hartung and Dr. Ed Fox, will provide an overview of the status of SPMS and the potential of Opexa’s T-cell immunotherapy in treating this population of MS patients.
Opexa is currently conducting the Abili-T trial, a Phase IIb study of Tcelna in SPMS patients. The trial is expected to enroll 180 patients at approximately 35 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.
Opexa expects the trial to be fully enrolled in the second quarter of 2014, with top-line data expected in mid-2016. At a recently held meeting, the independent Data and Safety Monitoring Board (DSMB) overseeing Opexa’s Abili-T trial recommended the trial continue as planned based on the committee’s review of safety data from the trial. The DSMB met on April 9, 2014 and found no significant safety concerns for the trial to date. Opexa has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Tcelna in SPMS.