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Oxygen Biotherapeutics and Aurum Biosciences Enter Joint Research Agreement to Develop an Oxycyte® - Based Diagnostic Tool and Therapeutic for Acute Ischemic Stroke
MORRISVILLE, N.C., Feb. 1, 2012 (GLOBE NEWSWIRE) -- Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) and privately held Aurum Biosciences Ltd. of Glasgow, Scotland, today jointly announced they have signed a long-term agreement to develop a better tool for defining the extent of injury in acute ischemic stroke and for treating this emergency in the important early hours after the attack. At the center of both efforts is Oxygen Biotherapeutics' proprietary, perfluorocarbon-based Oxycyte emulsion, which is known for delivering large amounts of oxygen to the brain. The key to the diagnostic work lies in Aurum's proprietary GOLD (Glasgow Oxygen Level-Dependent) Magnetic Resonance Imaging (MRI) technology, which has already shown great promise in mapping potentially salvageable tissue in the brain after stroke in the brain. more..
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Currently, we have one product candidate, Oxycyte PFC emulsion, in Phase IIb clinical trials in Switzerland and Israel for use in treating traumatic brain injury (TBI). This is a double-blind, placebo–controlled dose-escalation study. We have completed the first cohort and locked the database, and now are taking the appropriate steps to initiate the second cohort during year 2012.
Plans to expand our trials into India and to broaden the protocol to include milder forms of TBI are underway. At this time, we believe our study objectives as well as our safety and efficacy endpoints will remain the same under the new protocol. Furthermore, we believe these optimizations may enable us to conclude the study faster and more economically.
Phase I and IIb studies were conducted in the United States. A Phase IIb study protocol was filed with the FDA in the spring of 2008, but remains on clinical hold by the FDA due to questions raised by the regulatory agency. Earlier this year, we received a $2.07 million two-year cost reimbursement award from the U.S. Army to conduct safety related preclinical studies for Oxycyte PFC emulsion that will enable us to address the FDA's questions. The studies supported by this grant will examine the effect of the drug candidate on the immune system, platelet function and distribution, as well as the safety and efficacy of platelet transfusion, which can be conducted to evaluate the pharmacokinetics of PFCs in a relevant species. We believe the results of theses studies will support the safety profile of Oxycyte PFC emulsion.
For information on other clinical trials that are currently enrolling patients, please visit the following site: http://www.clinicaltrials.gov/