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Oxygen Biotherapeutics Secures Long-Term Clinical Supply of Oxycyte®
Company on Track to Resume Phase IIb Traumatic Brain Injury Trial Later This Year
MORRISVILLE, N.C., May 3, 2012 (GLOBE NEWSWIRE) -- Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT), a development stage biomedical company ("the Company") focused on developing perfluorocarbon-based intravenous and topical drug candidates, 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. more..
In the United States and Europe, revenues in the wound care market continue to increase due to increased rates of obesity, diabetes, an aging population and improved access to health care, according to a report by Rodman & Renshaw, which also estimates the market is $15 billion per year. Chronic, non-healing wounds are prevalent and costly. We are developing a topical gel based on our oxygenating perfluorocarbon formula to supply oxygen to the injured tissue. When a wound heals the speed of the healing is largely dependent on how much oxygen the key tissues get during their healing phase. We believe that our product has the potential to dramatically increase the speed of oxygen delivery, thereby increasing the speed of healing. Initial preclinical studies showed encouraging results of increased ephitheliazation. In addition, Department of Defense funded preclinical studies using our topical gel are being conducted by Hackensack University Medical Center.