Israel's Medical Corps Determines Soldiers Do Not Need Prior Approval to Participate
DURHAM, N.C., Sep 7, 2010 (GlobeNewswire via COMTEX) --
Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) (SIX Swiss Exchange:OXBT), a development stage biomedical company focused on developing oxygen-rich intravenous and topical products, today announced that Israeli soldiers who suffer severe traumatic brain injury (TBI) can be enrolled in the company's Phase II-b STOP-TBI trials at clinical sites in Israel. In view of this development, the company announced that it seeks to amend the existing study protocol to broaden the qualified patient enrollment population to include moderate/mild TBI patients. The company expects to reconvene enrollment in its second cohort after the required regulatory adjustments have been approved. The result of these two actions should increase the patient population that qualifies for enrollment in the study.
"Today, traumatic brain injury is one of the most common impairments faced by our military personnel all over the world. Land mines, rocket-propelled grenades and improvised explosive devices are now the most common tools of war. When they strike, body armor and helmets may protect, but what is not as easily recognizable is the damage these weapons are doing to service members' brains. Sometimes it is an obvious injury; other times it is mild to moderate. Therefore, we are considering modifying our study protocol to include moderate/mild TBI cases. As a company, we believe it is our duty to help these men and women who otherwise have little to no solution when afflicted with a brain injury. We are pleased that the Israeli Medical Corps will allow soldiers to participate," said Chris Stern, Chairman and Chief Executive Officer of Oxygen Biotherapeutics.
Currently, Oxygen Biotherapeutics has a Phase II-b clinical study underway to determine the safety and efficacy of using Oxycyte intravenously to treat severe TBI patients. These studies are being conducted at clinical sites in Switzerland and Israel with plans to expand into India. The company expects to allocate a substantial portion of its financial and business resources over the next few years to testing Oxycyte and advancing this product to regulatory approval for use in one or more medical applications.
Oxycyte oxygen carrier is a perfluorocarbon emulsified with water and a surfactant, which is provided to the patient intravenously. The physical properties of Oxycyte enable it to gather oxygen from the lungs and transport the oxygen through the body releasing it along the way. Increased oxygenation is vital for the recovery of TBI patients. TBI is a non-degenerative, non-congenital insult to the brain from an external mechanical force, possibly leading to permanent or temporary impairment of cognitive, physical, and psychosocial functions, with an associated diminished or altered state of consciousness.
About Oxygen Biotherapeutics, Inc.
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 and liquid ventilation product called Oxycyte(R) that is being formulated for both intravenous and topical delivery for conditions including but not limited to traumatic brain injury, decompression sickness and topical wounds. This same PFC is included in the Company's full line of personal skin care products. More information is available at www.oxybiomed.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 expansion of development of the Oxycyte and DERMACYTE product lines 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 reports on Form 10-Q and Form-10K. 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.
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SOURCE: Oxygen Biotherapeutics, Inc.
CONTACT: Oxygen Biotherapeutics, Inc.
Ellen Corliss, Vice President, Corporate Communications
& Investor Relations