Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing Tcelna ®, a patient-specific T-cell immunotherapy for the treatment of multiple sclerosis (MS), is pleased to announce the enrollment of the 126 th patient in the Phase IIb “Abili-T” clinical study of Tcelna (imilecleucel-T) in patients with Secondary Progressive Multiple Sclerosis (SPMS).
“We are pleased with the continued progress we have made in the Abili-T clinical trial and that patient enrollment has increased steadily over the past several months,” commented Neil K. Warma, Opexa’s President and Chief Executive Officer. “With the enrollment of patient number 126 in the trial, we have reached the 70% enrollment target out of a total of 180 patients. We are continuing our efforts to have the trial fully enrolled in early 2014. Furthermore, we are working with a few additional key multiple sclerosis centers and hope to have two more trial sites up and running shortly to support enrollment. This would increase the total number of clinical trial sites to 35 in the U.S. and Canada. We are especially pleased that many of the first sites that began enrolling patients at the trial’s outset continue to recruit patients into the study. This may reflect the interest that the Secondary Progressive MS patients have in participating in the Abili-T trial and the realization that there are limited treatments options currently available on the market for these patients. Additionally, we are proceeding well with our Immune Monitoring program, which is an important component of the Abili-T trial. The value of the Immune Monitoring program may enable us to evaluate a comprehensive panel of key anti-inflammatory and pro-inflammatory biomarkers associated with MS throughout the course of the Abili-T study. The analysis remains blinded during the course of the trial and we expect it to yield very interesting data on the disease profile of MS and on the mechanism of action of Tcelna.”