Oxygen Biotherapeutics, Inc. Receives Phase II Trial Approval In Israel

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 24 Sep 2009 - 2:00 PDT

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Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) announced that the company has received approval from Israel's Ministry of Health to begin a Phase II-b, dose escalation, clinical trial in that country for use of Oxycyte(R) in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.

"This approval from the Israeli Ministry of Health means that we can begin enrolling patients in a second country with a first class health care system," said Chris Stern, company chairman and CEO. "We hope this trial can provide data to show that Oxycyte is of invaluable importance in improving the outcome of patients, both civilian and military, with severe TBI. It is our goal to finally prove that there is a safe and effective treatment for this devastating injury."

The clinical trial with four centers in Israel is part of a larger study that also includes seven trial centers in Switzerland. The company has named the 128 patient study "Safety and Tolerability of Oxycyte in Patients with Traumatic Brain Injury" or "STOP TBI."

The dose escalation studies will focus on finding the lowest dose of Oxycyte that provides clinical benefit in traumatic brain injury while minimizing adverse effects. Dose levels of Oxycyte would start at 1.0 ml/kg body weight and escalate in steps to 2.0 ml/kg, and 3.0 ml/kg for subsequent patient cohorts. Escalation of dose will only occur after a favorable review of safety data by an independent Data Safety Monitoring Board.

About Oxygen Biotherapeutics, Inc.

Oxygen Biotherapeutics, Inc. is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and Defense Medicine(TM). The company has under development a perfluorocarbon (PFC) therapeutic oxygen carrier and liquid ventilation product (Oxycyte(R)) and has out-licensed an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for PFCs as well as medical and industrial applications for biosensors. Each of the product candidates is designed with advantages over currently marketed products in major markets including traumatic brain injury, sickle cell crisis, trauma, wound care, decompression sickness, acute respiratory distress syndrome, stroke, myocardial infarction, surgery, diabetes wounds and ulcers, and cosmetic applications.

Source: Oxygen Biotherapeutics, Inc

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