Opexa Therapeutics, Inc. (NASDAQ:OPXA), a biotechnology company developing a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the year ended December 31, 2011 and provided an overview of corporate developments during the last year.
2011 highlights include:
Clinical and Regulatory
- Granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for Tovaxin® for the treatment of patients with Secondary Progressive Multiple Sclerosis (SPMS);
- Published the results of the Company’s prior Phase IIb TERMS clinical trial of Tovaxin in a leading peer-reviewed publication, Multiple Sclerosis Journal;
- Executed strategic agreements with the American Red Cross and the Blood Group Alliance, Inc. to streamline blood procurement for future clinical trials; and
- Met with Health Canada’s Biologics and Genetics Therapies Directorate as part of the process to secure approval for Opexa to conduct a portion of future clinical development in Canada.
- Optimized the manufacturing process through the implementation of a functionally closed system and single cycle cGMP process;
- Advanced overall clinical plans for Tovaxin and clearly defined the study protocol for the planned Phase IIb clinical trial in SPMS;
- Increased employee headcount thereby strengthening our overall cell therapy expertise in preparation for the planned clinical trial in SPMS; and
- Designed and implemented a proprietary Web-based system to manage patient and product flow throughout future clinical studies.
- Closed a financing of $8.5 million in gross proceeds through an underwritten public offering in February 2011.
“2011 was a very productive year for Opexa as we remained clearly focused on the preparations for our next clinical trial with Tovaxin,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “We made a firm decision, based on numerous conversations with key MS opinion leaders, clinicians, pharmaceutical companies, and the FDA to target Secondary Progressive MS. We remain on track to initiate the Phase IIb clinical trial in SPMS within a period of several months subject to securing the necessary resources. We are most pleased with our recruiting efforts as we have been able to hire numerous experts in cell therapy in the areas of manufacturing, quality assurance, quality control and R&D. It is our belief that Tovaxin could be the therapy of choice for many MS patients; and if we are able to demonstrate success, especially in SPMS patients, we will change the course of how MS is treated and will have built significant value in the company.”
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