Oxygen Biotherapeutics Secures Long-Term Clinical Supply of Oxycyte(R)
Oxygen Biotherapeutics, Inc. (Nasdaq: OXBT) today announced it has achieved the critical milestone of securing an exclusive supply of cGMP-compliant Oxycyte®, the Company's proprietary perfluorocarbon based emulsion, that will take the Company through the current Phase II clinical trial for traumatic brain injury (TBI) and well into Phase III trials.
Key to this recent development was the signing of a contract with the manufacturer of cGMP-compliant FtBu, the proprietary, patent-protected active pharmaceutical ingredient in Oxycyte. Per the agreement, Oxygen Biotherapeutics has the exclusive rights to the supply of FtBu manufactured by this supplier. In addition, the Company is now aligned with a California-based contract manufacturer that will produce Oxycyte based on the Company's new scaled-up process for making the emulsion. Results from recent engineering batches made by this new supplier demonstrate that Oxycyte continues to meet all required specifications for product release.
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