Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended March 31, 2012 and provided an update on recent corporate developments.
Corporate development highlights include:
- Submission to the FDA for final review of the protocol for a Phase IIb clinical trial for Tovaxin in patients with Secondary Progressive MS (SPMS) and, after receiving no additional comments from the FDA, being positioned to proceed with the trial from a regulatory perspective;
- Conducting a kick-off meeting with prospective clinical trial investigators at the 64 th Annual American Academy of Neurology (AAN) meeting to review patient enrollment practices and the planned clinical trial details and protocol;
- Executing an agreement with Pharmaceutical Research Associates, Inc. (PRA) to provide contract research organization (CRO) services to support the planned clinical trial;
- Advancing preparations with numerous clinical trial sites; and
- Strengthening our overall cell therapy expertise, including key hires in Manufacturing and Quality Control.
“We are progressing favorably in the planning and preparations for a clinical trial in Secondary Progressive MS patients,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “The clinical trial protocol was submitted to the FDA for final review and we received no additional comments from them. This is a key milestone for us, providing us with the necessary regulatory positioning to advance with the trial preparations and discussions with potential trial sites. Operationally, we believe we remain on track to initiate the trial in the coming months as the team continues to work diligently to finalize preparations. In order to initiate the trial, we will need to secure additional financing, either through a potential partnership or additional capital raise, and this continues to be an important focus for us.”