Opexa Therapeutics reaches enrollment target in Phase IIb trial Opexa Therapeutics reported it has reached the targeted enrollment in its Phase IIb clinical trial in Secondary Progressive Multiple Sclerosis. As of today, 180 patients with Secondary Progressive MS have been randomized in the Phase IIb “Abili-T” clinical study of Tcelna. The company will also allow patients who are currently in the screening process at the time of full enrollment and who meet the trial’s entry criteria to also be enrolled in the trial. The Abili-T trial is a Phase IIb study of Tcelna in patients with Secondary Progressive MS in 35 leading clinical sites in the U.S. and Canada. Each patient is 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 at 24 months. Top line data is expected in mid-2016. Opexa has received Fast Track designation from the U.S. FDA for Tcelna in Secondary Progressive Multiple Sclerosis. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, as well as fill an unmet medical need and get important new drugs to patients earlier.
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Opexa Therapeutics terminates public offering of common stock Opexa Therapeutics announced that it has terminated the public offering of shares of its common stock previously announced on Monday, September 15. The termination results from an assessment by Opexa’s management that current market conditions are not conducive for an offering on terms that would be in the best interests of Opexa’s stockholders. As a result of such termination, no shares will be sold pursuant to the offering.