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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..
According to the Department of Defense Personnel and Procurement Statistics, 75% of all U.S. military casualties of Operation Enduring Freedom and Operation Iraqi Freedom are caused by explosive weaponry, resulting in TBIs and blast-induced neurotrauma, which have been called the "signature wounds" of these wars. They estimate that TBI accounts for about 22 percent of all casualties. In a January 2006 report, the Centers for Disease Control (CDC) estimated that 1.4 million U.S. civilians sustain TBI each year. Of them, about 50,000 die, 235,000 are hospitalized and 1.1 million are treated and released from an Emergency Department. An estimated 80,000-90,000 people with TBI experience permanent disability from their injury. These incidence rates have led the CDC to conclude that TBI prevention, improved acute care and rehabilitation to reduce the likelihood of TBI-related disability, and increased access to services for those who do not fully recover must continue to be national priorities.
We are conducting Phase IIb clinical trials in Switzerland and Israel with our Oxycyte PFC emulsion. Our study is a double-blind, placebo controlled dose-escalation study designed to evaluate the safety, efficacy and dosing parameters of Oxycyte PFC, a novel perfluorocarbon emulsion that is given intravenously to traumatic brain injury patients. The study protocol calls for three dose cohorts (1-3mL per kg body weight). The study's first cohort has been completed and the database has been locked. The second cohort has been approved by DSMB. Currently, we are considering revising the protocol to include moderate/mild TBI patients in trial and are gearing up our manufacturing process to meet the needs of our trials. We anticipate initiating the second cohort in 2012.
Oxycyte Traumatic Brain Injury – Dr. Gerald Klein, "What is severe traumatic brain injury? Can Oxycyte help?"