Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended September 30, 2012 and provided an overview of recent corporate developments.
Third quarter and recent highlights include:
- Commenced the Abili-T clinical study, a Phase IIb clinical trial of Tcelna in patients with Secondary Progressive Multiple Sclerosis (SPMS);
- Closed a $4,085,000 convertible secured note financing;
- Entered into two purchase agreements in which Opexa has the right to sell, over a 30-month period, up to $16.5 million in shares of its common stock to an institutional investor, subject to certain conditions and limitations; and
- Received approval from Health Canada enabling expansion of the Abili-T clinical trial into Canada.
“After extensive preparations up through August of this year, including the enhancement of our Tcelna manufacturing process and the optimization of our clinical development strategy, we successfully returned to the clinic in September and initiated the Abili-T clinical study, a Phase IIb clinical trial in patients with SPMS,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “The enthusiastic response by physicians and patients alike to the Abili-T study has resulted in good initial enrollment. The two-year trial is expected to enroll a total of 180 SPMS patients in 30 sites in the U.S. and Canada. Currently, we have secured contracts with over half of the clinical sites and continue to progress in discussions with additional sites that have expressed a desire to participate in the study. We have enrolled approximately ten percent of the patients to date in the clinical study and expect enrollment to expand as more sites become activated and begin to screen potential patients. We are also pleased to have received approval by Health Canada, the Canadian equivalent of the U.S. Food and Drug Administration, to expand the trial with Canadian sites. Given Tcelna’s previously demonstrated strong safety profile, along with very limited treatment options currently available in SPMS, we expect enrollment of the Abili-T study to progress well.”