Opexa Therapeutics, Inc., a drug delivery company based in The Woodlands, Texas, has been making significant progress in researching and developing Tcelna®, a breakthrough T-cell immunotherapy for multiple sclerosis (MS). The company recently announced they have reached their enrollment mark for conducting a Phase IIb clinical trial to test Tcelna as a viable treatment for Secondary Progressive MS.
Opexa has announced that there are currently 180 participants with Secondary Progressive MS enrolled in their “Abili-T” clinical trial for Tcelna, all of whom will be randomized to receive either the therapy or a placebo. As for individuals who are still completing the study’s screening process, Opexa noted that they will still allow them to enroll in the trial, provided they meet the study’s criteria. This ultimately means that the study could potentially finish the enrollment process with more than 180 subjects.
Dr. Edward Fox, M.D., Ph.D., an enrolling neurologist involved in the Abili-T trial, commented that, due to the fact that there are only a small number of accepted treatments for Secondary Progressive MS, the success of the Abili-T trial will be a step closer to providing a potentially more effective therapy for SPMS patients, as all current treatments are officially designated for the relpasng-remitting form of the disease.
Abili-T will be carried out in 35 select clinics across the U.S. and Canda, with each participant contracted to receive two yearly treatment courses of Tcelna, comprised of five subcutaneous injections. The researchers will measure the trial’s efficacy on the degree to which the brain volume changes at the end of 24 months.
Opexa currently holds a Fast Track designation from the Food and Drug Administration (FDA) for Tcelna and its potential use to treat Secondary Progressive MS. This means that Tcelna may go through an expedited review process in order to make it available to the SPMS patient community, assuming it is a success.
Opexa CEO Neil Warma recently gave a talk about the Abili-T trial at the company’s Q1 earnings call on May 14th. In March, Opexa published a financial report on their 2013 year end financial results along with a corporate update.