Stockwire.com: Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) just released some important news

The primary goals of these dose escalation safety and efficacy studies are to augment the clinical program with mechanistic research and determine the optimal dose for Oxycyte to result in a better outcome for patients on the Extended Glasgow Outcome Scale (EGOS). EGOS will be a primary efficacy end...

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Bibliographic Details
Published inM2 Presswire
Format Newsletter
LanguageEnglish
Published Coventry Normans Media Ltd 23.10.2008
Subjects
Brain research
Clinical trials
Compensation
Conflicts of interest
Critical path
Drug dosages
Editors
Investments
Investors
Perfluorocarbons
SEC regulations
Stockholders
Thrombocytopenia
Traumatic brain injury
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Summary:The primary goals of these dose escalation safety and efficacy studies are to augment the clinical program with mechanistic research and determine the optimal dose for Oxycyte to result in a better outcome for patients on the Extended Glasgow Outcome Scale (EGOS). EGOS will be a primary efficacy endpoint for clinical benefit. Both the U.S. and Canadian studies will be designed as multi-center studies focusing on finding the lowest dose that reduces thrombocytopenia and still provides clinical benefit in traumatic brain injury. Related to this, the company has decided to take advantage of a unique window of opportunity to add a human study to understand the effects of thrombocytopenia and platelets in PFCs with scientific clarity not otherwise achievable in any animal model. "This gives us a more efficient way to advance our clinical trials. It is extremely important to bring Oxycyte another step forward because we have a level of obligation to TBI patients and their families," said company chairman and CEO Chris J. Stern, DBA. "Right now there is no medical treatment for TBI patients and mortality is 20 -- 25 per cent. Additionally, of those that survive, half are unable to return to the lives they had before their injury. The procedure in the dose escalation studies is designed to find the safest dose level of our drug and to bring it to market in due course. These dose escalation studies are the foundation to move to the next step of enrolling and treating TBI patients and showing what Oxycyte can do to help them recover and lead normal, productive lives." "While these studies are going on, we will be aggressively working on our other priority clinical applications for Oxycyte," said Dr. Richard Kiral, company President and COO. "The next in line is topical wound treatment, where we intend to file device and drug applications soon. Sickle cell pain crisis is in an intense planning phase. We are now preparing a protocol for a Phase IIa trial for that indication in the Caribbean and intend to file it in due course," Kiral said.