- 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.
Opexa Therapeutics Reports Year End 2011 Financial Results And Provides Corporate Update
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