Opexa Therapeutics Provides MS Trial Enrollment Update; 70% of Patients Enrolled

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, Opexas 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 trials 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.

Opexa management will be meeting investors in San Francisco from January 13th through the 16th, 2014. Please send meeting requests to opexa@troutgroup.com.

About Opexa

Opexas mission is to lead the field of Precision Immunotherapy by aligning the interests of patients, employees and shareholders. The Companys leading therapy candidate, Tcelna, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive MS. Tcelna is derived from T-cells isolated from the patients peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin.

About Multiple Sclerosis (MS)

MS is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide.

While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. The Secondary Progressive form of MS represents about a third of the MS patient population.

About Tcelna

Tcelna is a potential personalized therapy that is under development to be specifically tailored to each patient's disease profile. Tcelna is manufactured using ImmPath, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response.

Opexa is currently conducting a Phase IIb study of Tcelna. Named Abili-T, the trial is a randomized, double-blind, placebo-controlled clinical study in patients who demonstrate evidence of disease progression with or without associated relapses. The trial is expected to enroll 180 patients at approximately 33 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trials primary efficacy outcome is the percentage of brain volume change (atrophy) at 24 months. Study investigators will also measure several important secondary outcomes commonly associated with MS, including disease progression as measured by the Expanded Disability Status Scale (EDSS), annualized relapse rate and changes in disability as measured by EDSS and the MS Functional Composite.

Read this article:
Opexa Therapeutics Provides MS Trial Enrollment Update; 70% of Patients Enrolled