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 ďAbili-TĒ 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 trialís 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 trialís 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.
Opexa Therapeutics to present biomarker data from NMO patients at AAN meeting Opexa Therapeutics announced that it has been invited to present data on the immune profile of patients with NMO at the 67th American Academy of Neurology Annual Meeting in Washington D.C. Opexa will present the results of a study conducted to characterize the cellular immune profile of NMO patients prescribed B-cell depleting therapy in comparison to those of healthy donors. The results showed that despite administration of B-cell depleting therapy, inflammation continued to persist as did the presence of activated T-cells. Opexa has a preclinical development program in NMO and IND enabling activities are currently being conducted with its drug development candidate, OPX-212.