Oxygen Biotherapeutics Receives DSMB Approval To Proceed To The Next Cohort In Its Phase II-B Clinical Trial For Traumatic Brain Injury
DURHAM, N.C., Sept. 23, 2010 (GLOBE NEWSWIRE) -- Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) (SIX Swiss Exchange:OXBT) reported today that the Data Safety Monitoring Board overseeing the company's ongoing Phase II-b trial has, based on the results of the first cohort of patients, authorized the company to move forward with the next cohort of the study. This trial is a randomized, single-dose, placebo-controlled, double-blind, dose-escalation study to evaluate the safety and tolerability of our Oxycyte ® emulsion in patients with severe non-penetrating traumatic brain injury. Due to the double-blind design of the study, specific results will not be reported to the company until the trial closes.
"The absence of any safety concern on the part of the DSMB and their unanimous recommendation to proceed with the next cohort represents a significant milestone for our clinical program. We look forward to moving into doses where signs of efficacy are expected. Recent updates in the area of traumatic brain injury and feedback from experts in the field as well as our clinical investigators has motivated us to consider expanding our existing protocol's patient enrollment parameters beyond severe non-penetrating traumatic brain injury to include mild-to-moderate TBI patients," said Timothy Bradshaw, Ph.D., Senior Vice President of Clinical Development at Oxygen Biotherapeutics. "These changes will take time to implement, but we believe that in the long run it is the right move since more patients will be eligible to enroll in our trial and potentially benefit from treatment with Oxycyte."
What is Oxycyte ® PFC Emulsion?Oxycyte is an emulsion of a proprietary perfluorocarbon (PFC) based oxygen carrier and is administered to clinical trial patients via intravenous infusion. The physical properties of PFC enable our product to gather oxygen from the lungs and transport the oxygen through the body releasing it along the way. Over a period of days following administration, Oxycyte is gradually cleared from the body through the lungs in the course of respiration. Oxycyte requires no cross matching, so it is immediately available and compatible with all patients' blood types. It is provided to our clinical researchers as a sterile emulsion ready for intravenous administration. Because it contains no biological components, there is no risk of transmission of blood-borne viruses from human blood products.
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