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Oxygen Biotherapeutics Announces Halt of Oxycyte Phase IIb Traumatic Brain Injury Trial

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Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT), a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that the Company, with unanimous approval from the Board of Directors, has elected to stop the current Phase IIb trial for its Oxycyte drug candidate and consider strategic alternatives for the program moving forward. The company will review the data generated on the patients enrolled in the trial to date.

“With the difficulties we have had enrolling patients at the current Phase IIb clinical sites for Oxycyte, the Oxygen Board of Directors and management team has decided that completing this trial in a reasonable period of time is not feasible,” said Dr. Ronald Blanck, Chairman of the Oxygen Board of Directors. "We will be considering strategic alternatives for Oxycyte moving forward.”

Oxycyte, a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier, was in clinical and preclinical studies for intravenous delivery in indications such as traumatic brain injury, decompression sickness and stroke. The current Phase IIb study was evaluating the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury (STOP-TBI).

The Company will be focusing resources on its lead critical care product, levosimendan, a calcium sensitizer in Phase 3 development in the United States for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS).

In July 2014, Oxygen initiated a Phase 3 trial in the United States to evaluate levosimendan in cardiac surgery patients at risk of developing LCOS. The FDA has granted Fast Track status for levosimendan in this indication.

Posted-In: News FDA Press Releases


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