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Oxygen Biotherapeutics halts Phase IIb traumatic brain injury trial of Oxycyte

Oxygen Biotherapeutics has decided to stop the current Phase IIb trial of its drug candidate Oxycyte indicated for the treatment of patients with traumatic brain injury.

The Phase IIb trial was assessing the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury (STOP-TBI).

The decision to halt the trial comes after unanimous approval from the company’s board of directors.

The company will review the data generated to date on the patients enrolled in the trial of Oxycyte, a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier.

Oxygen board of directors chairman Dr. Ronald Blanck said, "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."

Oxycyte was evaluated in clinical and preclinical trials for intravenous delivery in indications such as traumatic brain injury, decompression sickness and stroke.

The company will be focusing resources on its lead critical care product, levosimendan, a calcium sensitizer in Phase III development in the US to reduce morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS).

In July, the company started a Phase III trial in the US to assess levosimendan in cardiac surgery patients at risk of developing LCOS.

Levosimendan is developed for intravenous use in hospitalized patients with acutely decompensated heart failure.