Oxygen Biotherapeutics announced today that it has been notified by 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.
On September 23, 2013, the company announced that it had submitted to the FDA results from two series of animal studies designed to address FDA concerns regarding the use of Oxycyte in treating traumatic brain injury (TBI) patients. These studies were conducted to probe both the interactions between Oxycyte and the immune system, as well as assess the PFC-based emulsion’s potential to increase the risk of intracerebral hemorrhage (ICH). This submission has formed the basis for the FDA’s decision to lift the clinical hold. “We are pleased that the FDA has responded favorably to the data provided and removed the clinical hold to allow further clinical development of Oxycyte,” said John Kelley, CEO.
Prior to the initiation of any human clinical studies using Oxycyte in the US, the company will need to develop an FDA approved protocol which will incorporate FDA input on the design and safety measures to be utilized in such studies. Oxygen is currently enrolling patients outside of the US in a Phase II-b study to evaluate the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury (STOP-TBI). The study is currently enrolling patients in Israel for the second cohort of a three cohort trial.