Aug 12 2008
Oxygen Biotherapeutics, Inc. has announced that the company has developed a gel-like form of Oxycyte that it intends to investigate as a topical application for open wounds, abrasions and burns. Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.
The innovation is based on technologies in-licensed earlier this year from Virginia Commonwealth University. In combination with a hydrogen peroxide pouch, researchers believe the compound could have superior abilities to deliver a high concentration of oxygen directly to the wounded tissue. The combination of Oxycyte gel and H2O2 is believed to be the key to its possible efficacy. The company intends to submit to the FDA a protocol for a proposed clinical investigation before the end of the calendar year.
“Unlike the intravenous drug application of Oxycyte in traumatic brain injury, this would be a topical application, applied to the skin or to the surface of wounds. So we’re hopeful that the clinical review process would be as a medical device, which can be shorter and faster than review as a drug,” said company chairman and CEO Chris J. Stern, DBA. “If the safety/efficacy cycle is indeed shorter, as I believe it can be, then it suggests that substantive partnering models could be launched shortly after safety and efficacy are proven. Sales of ointments, dressings, bandages, etc are counted in the high billions of dollars each year. I think that every one of these products could prove to be a candidate to carry a form of Oxycyte.
“While I’m excited about this new potential use for Oxycyte, I know that the big question on our shareholders’ minds right now is the status of our Phase IIb protocol for Oxycyte in TBI. We’re not going to get into the details of our communications with the FDA. That would not be in the best interests of the company or the process. I’ll just say that positive communications are continuing and that when there is news, we’ll announce it,” said Stern.
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