Health News

12 Feb 2009 07:00 AM

Oxygen Biotherapeutics, Inc. Announces Plans For Additional Oxycyte(R) Phase II Clinical Trials
Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) today announced plans to file a Phase II, dose escalation, clinical trial protocol in Switzerland for use of Oxycyte® in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.

The announcement came in a presentation today by Chris J. Stern, DBA, company chairman and CEO, at the BIO CEO & Investor Conference in New York. During the presentation, Stern said that the company is in the final stages of preparation to file the protocol in Switzerland. "Depending on the timing of the review process there, we could begin enrolling patients in the second quarter," said Stern.

In addition, Stern said in the presentation that the company is targeting to have a topical wound care product ready to come to market as early as the end of 2009.

After the conference presentation, Stern added, "We're pushing ahead with our Oxycyte Phase II plans without waiting for the FDA. When we received the recent letter from them informing us, that after reviewing our data, they are not yet ready to allow us to resume clinical trials in traumatic brain injury, we were surprised with their conclusion. But we're not going to stop our Oxycyte development while we work on resolving our disagreement with the agency. Rather than lose any more time, we will be filing in Switzerland before the end of this month the same protocol that we intend to submit to the FDA…
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