About Oxygen Biotherapeutics
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Oxygen Biotherapeutics Inc. Provides an Update on Communication with the FDA Regarding Oxycyte Development Program
Tuesday, March 4, 2014 5:00 am PST
Public Company Information:
Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, announced today that it has been notified by the U.S. Food and Drug Administration (the “FDA”) that the agency has completed its review of the September 2013 nonclinical submission and has lifted the clinical hold on Oxycyte®. Lifting of the clinical hold clears the company to proceed with the clinical development program in the US. The FDA communicated this information to the company during a conference call with the FDA on Friday, February 28, 2014. Written confirmation of the FDA’s decision is expected to be received within 30 days. more..
Oxygen is essential to life. When that supply is shut off the results can range from minor to devastating. At Oxygen Biotherapeutics, our goal is to help the human body maintain a sufficient oxygen supply to stop disease and damage to tissues that occurs when the flow of oxygen is suddenly interrupted or diminished.
Currently, we are developing medical products designed to deliver oxygen to specific tissues in the body that are deprived of oxygen. Our most advanced product, Oxycyte PFC, is in Phase IIb clinical trials in Switzerland and Israel for traumatic brain injury. Oxycyte PFC is an intravenously delivered perfluorocarbon-based drug that we believe has therapeutic benefits for acute ischemic conditions. The first cohort of the Phase IIb trail is complete. The second cohort was initiated in May 2013.
In addition, we are developing a PFC-based topical cream that we believe has potential benefits for dermatologic indications and wounds. Studies in this area were completed in India.