Opexa Therapeutics (NASDAQ:OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders, today announced that the Phase 2b Abili-T clinical trial designed to evaluate the efficacy and safety of Tcelna® (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS) did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression. Tcelna did show a favorable safety and tolerability profile.
“We are disappointed that Tcelna did not meet the predefined endpoints in the Abili-T trial,” said Neil K. Warma, President and Chief Executive Officer of Opexa. “We will evaluate the full data set over the coming weeks and review cash preservation options while we consider the best path forward for the company.”
Abili-T is a 183-patient, randomized, double-blind, placebo-controlled Phase 2b study (ClinicalTrials.gov Identifier: NCT01684761) that was conducted at 35 clinical trial sites in the U.S. and Canada. Patients in the Tcelna arm of the study received two annual courses of Tcelna treatment consisting of five subcutaneous injections per year.
“We would like to express our sincere thanks to the patients in the Abili-T trial, as well as to the principal investigators and study coordinators, for their contributions to the study,” said Mr. Warma.
About Opexa Therapeutics
Opexa Therapeutics is a biopharmaceutical company developing personalized immunotherapies based on ImmPath®, its proprietary T-cell technology, with the potential to treat autoimmune diseases. Opexa’s staff of cell therapy experts operates in a stand-alone facility located on one acre in the Woodlands, Texas. The facility is comprised of over 10,000 sq. ft. of state of the art space for cGMP manufacturing suites, a quality control laboratory, a research and development laboratory, quality assurance, specialized flow cytometry, a microscopy lab and clinical and regulatory affairs, as well as warehouse space for materials management. Opexa’s patent estate is currently comprised of over 160 issued patents (domestic and international).