THE WOODLANDS, Texas, Nov. 9, 2010 (GLOBE NEWSWIRE) -- Opexa Therapeutics, Inc. (Nasdaq:OPXA), a leading cell therapy company developing a proprietary autologous T cell therapy platform for the treatment of autoimmune diseases, including Tovaxin®, its lead therapy for multiple sclerosis (MS), today reported financial results for the quarter ended September 30, 2010 and provided an update on recent corporate developments.
- Manufacturing/Process Development:
- Implementation of key process improvements and optimization of manufacturing process advanced as planned;
- Documentation to support FDA Regulatory review is nearing completion;
- Clinical Development:
- Clinical Study Protocols continue to be developed and finalized for discussions with FDA;
"During the third quarter of 2010, we remained focused on positioning the Company for further clinical studies with Tovaxin. There was and remains a significant amount of work and preparation required to be able to again treat patients under a clinical trial setting, but I am pleased with the substantial progress that has been made by everyone at Opexa to this end," commented Neil K. Warma, President and Chief Executive Officer of Opexa. "We are actively preparing for meetings with the FDA which we reasonably expect to take place toward the end of the year and are finalizing the documents and reports that will support these important discussions."
- Opexa was awarded $244,000 in a grant under the Qualifying Therapeutic Discovery Project (QTDP) Program to advance the development of its lead product, Tovaxin®, for MS. The QTDP grant program provides support for innovative projects that are determined by the U.S. Department of Health and Human Services to have reasonable potential to result in a new therapy, reduce health care costs, or significantly advance the goal of curing diseases.