MORRISVILLE, N.C., June 7, 2011 (GLOBE NEWSWIRE) -- Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) (SIX Swiss Exchange:OXBT) today announced it has received approval by the Drug Controller General of India to conduct its traumatic brain injury Phase IIb clinical trials known as STOP-TBI. Oxygen Biotherapeutics believes adding clinical investigators in India to its existing clinical sites in Switzerland and Israel will enable the Company to conclude the study faster and more economically. The next cohort is expected to begin in the second half of fiscal year 2012.
Dr. Tim Bradshaw, Executive Vice President of Clinical Development at Oxygen Biotherapeutics, believes the addition of India to its existing clinical sites in Switzerland and Israel is an important step in the clinical development plan for Oxycyte® PFC. "Traumatic brain injury is a leading cause of mortality and morbidity in India with an estimated incidence of 150 per 100,000. In the city of Bangalore alone, nearly 10,000 individuals sustain brain injury and more than 1,000 die every year. Expanding our trial into countries such as India will help us to accelerate completion of the study."
"We are pleased that we received this approval and look forward to working with our new clinical sites," said Chris Stern, Chairman and Chief Executive Officer of Oxygen Biotherapeutics. "Currently, we are exploring whether to amend the protocol to include patients with milder forms of TBI, and we are developing the processes for manufacturing cGMP Oxycyte PFC for the study. In addition, we are seeking a partner to help us execute the remaining aspects of this trial because we believe that makes strategic sense and is in the best interest of our shareholders and patients."
The STOP-TBI study is a double-blind, placebo controlled dose-escalation study designed to evaluate the safety, efficacy and dosing parameters of Oxycyte PFC, a novel perfluorocarbon emulsion that is given intravenously to traumatic brain injury patients. The study's first cohort has been completed and the database has been locked.
About Oxygen Biotherapeutics, Inc.
Headquartered in Morrisville, NC, Oxygen Biotherapeutics, Inc. is developing medical and cosmetic products that efficiently deliver oxygen to tissues in the body. The company has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier that is being formulated for both intravenous and topical delivery. This year, the company launched its DERMACYTE® line of oxygen-rich skin care products. In addition, the company is focused on perfluorocarbon-based oxygen carriers for use in traumatic brain injury, decompression sickness, personal care, dermatology and topical wound healing. More information is available at www.oxybiomed.com or www.dermacyteus.com.
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Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company's judgment as of the date of this release. These statements include the management transition, and expansion of research and development of the Oxycyte product line, including and the timing of the introduction of those new products. The forward-looking statements are subject to a number of risks and uncertainties including matters beyond the company's control that could lead to delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in our filings with the Securities and Exchange Commission, including in the current report on Form 10-Q filed on September 9, 2010. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.