Tenax Therapeutics, formerly named Oxygen Biotherapeutics, a Morrisville, N.C.-based specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, has 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 Tenax 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 Tenax board. "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 III development in the U.S. for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing low cardiac output syndrome (LCOS). The FDA has granted Fast Track status for levosimendan in this indication.