Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company has executed an agreement with Blood Group Alliance, Inc. (BGA), a cooperative of community blood centers, to provide blood collection services to support Opexa’s clinical studies, including a planned Phase III study of Tovaxin in patients with Relapsing-Remitting MS.
This agreement will substantially enhance the overall process for the production of Tovaxin as the first step in the manufacturing process is obtaining a unit of whole blood from the patient. With BGA’s North American footprint extending throughout the United States and into Canada, patients in Opexa’s clinical trials will have access to a very broad network of treatment centers ensuring improved efficiency in blood collection. BGA has agreed to manage the collection of the blood and ship the units to Opexa’s facility for further manufacturing of the Tovaxin product. Opexa recently announced a similar agreement with the American Red Cross. In combination, these two groups provide Opexa with access to over 90% of the blood procurement centers in the United States. With these agreements, Opexa has now put into place a strong network of procurement locations nationwide which provide feasibility for commercialization as well as an excellent supply chain for Opexa’s future clinical studies.
"The feasibility of procurement for the clinical manufacture of Tovaxin has been solidified with the execution of these agreements,” commented Jaye Thompson, Ph.D., Senior Vice President, Clinical Development and Regulatory Affairs of Opexa. “We are pleased to be associated with BGA and their network of community blood centers. Our partnership will allow Opexa great flexibility to utilize investigational sites in almost any location for future Tovaxin studies. This unlimited access will be valuable for our patients and physicians. In addition, these contracts should result in a stable and reduced cost of goods in the manufacture of Tovaxin.”
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