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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..
Decompression Illness (DCI), commonly known as "the bends", is a serious condition that results from a reduction in the ambient pressure surrounding a body. A good example is what happens when a diver surfaces too quickly without giving his/her body a chance to acclimate to the change in pressure when they ascend.
DCI encompasses two diseases, decompression sickness (DCS) and arterial gas embolism (AGE). DCS is thought to result from nitrogen bubbles expanding in tissue and causing local damage, while AGE results from nitrogen bubbles entering the lung circulation, traveling through the arteries and causing tissue damage at a distance by blocking blood flow at the small vessel level. DCS is the result of inadequate decompression following exposure to increased pressure. In some cases, the disease is mild and not an immediate threat. In other cases, serious injury does occur. When this happens, the quicker treatment begins, the better the chance for a full recovery.
Oxygen Biotherapeutics has a Cooperative Research and Development Agreement with the US Navy for DCI. Per the agreement, we supply Oxycyte PFC emulsion for their ongoing preclinical research exploring the potential of using Oxycyte for decompression illness
Oxycyte and Decompression Illness – Dr. Gerald Klein explains Decompression Illness.