Oxygen Biotherapeutics, Inc. (“OBI”) OXBT, announced today that it
has signed a Cooperative Research and Development Agreement (CRADA) with the
U.S. Army Institute of Surgical Research (USAISR) at Fort Sam Houston Texas to
explore the potential effects of OBI's proprietary perfluorocarbon-based
emulsion, Oxycyte, on platelet function and blood hemostasis. This CRADA has
been initiated to complement ongoing research and development work funded
previously by a Department of Defense grant to broaden the safety profile of
the use of perfluorocarbon-based emulsions to treat patients with traumatic
brain injury – an indication for which OBI is conducting Phase II clinical
trials overseas.
Although a known response to perfluorocarbon-based emulsion products is the
transient decline in circulating platelet counts, the mechanism by which this
phenomenon occurs is poorly understood and its impact on overall coagulation
pathways and clinical outcomes remains the subject of debate. Recently
completed in vitro studies using blood from normal healthy human volunteers at
the Children's Hospital in Boston have demonstrated that Oxycyte has little
effect on the activation and function of platelets. The research being
conducted under the present CRADA will investigate whether Oxycyte alters
platelet activation, aggregation or adhesion in a model of systemic
inflammation. Researchers will conduct ex vivo evaluations of platelet
activity and whole blood clotting functions. Changes in the structural and
functional properties of platelets will be evaluated including receptor
expression and distribution, and aggregation in response to agonists. This
work will be part of a larger study to determine the biodistribution of
platelets following Oxycyte administration in this model. The company has
undertaken this extensive preclinical program to address concerns that the
U.S. FDA has expressed regarding perfluorocarbon-based emulsions.
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