EANS-Adhoc: Oxygen Biotherapeutics Receives DSMB Approval to Proceed to the Next Cohort in Its Phase II-B Clinical Trial for Traumatic Brain Injury
ad-hoc disclosure transmitted by euro adhoc with the aim of a Europe-wide distribution. The issuer is solely responsible for the content of this announcement.
Research & Development/Biotechnology
23.09.2010
DURHAM, NC, September 23, 2010 - Oxygen Biotherapeutics, Inc. (NASDAQ & SIX Swiss Exchange: OXBT) reported today that the Data Safety Monitoring Board overseeing the company´s ongoing Phase II-b trial has, based on the results of the first cohort of patients, authorized the company to move forward with the next cohort of the study. This trial is a randomized, single-dose, placebo-controlled, double-blind, dose-escalation study to evaluate the safety and tolerability of our Oxycyte® emulsion in patients with severe non-penetrating traumatic brain injury. Due to the double-blind design of the study, specific results will not be reported to the company until the trial closes.
"The absence of any safety concern on the part of the DSMB and their unanimous recommendation to proceed with the next cohort represents a significant milestone for our clinical program. We look forward to moving into doses where signs of efficacy are expected. Recent updates in the area of traumatic brain injury and feedback from experts in the field as well as our clinical investigators has motivated us to consider expanding our existing protocol´s patient enrollment parameters beyond severe non-penetrating traumatic brain injury to include mild-to-moderate TBI patients," said Timothy Bradshaw, Ph.D., Senior Vice President of Clinical Development at Oxygen Biotherapeutics. "These changes will take time to implement, but we believe that in the long run it is the right move since more patients will be eligible to enroll in our trial and potentially benefit from treatment with Oxycyte."
end of ad-hoc-announcement ========================================== ====================================== What is Oxycyte® PFC Emulsion?
Oxycyte is an emulsion of a proprietary perfluorocarbon (PFC) based oxygen carrier and is administered to clinical trial patients via intravenous infusion. The physical properties of PFC enable our product to gather oxygen from the lungs and transport the oxygen through the body releasing it along the way. Over a period of days following administration, Oxycyte is gradually cleared from the body through the lungs in the course of respiration. Oxycyte requires no cross matching, so it is immediately available and compatible with all patients' blood types. It is provided to our clinical researchers as a sterile emulsion ready for intravenous administration. Because it contains no biological components, there is no risk of transmission of blood-borne viruses from human blood products.
Traumatic Brain Injury
According to the Centers of Disease Control, TBI is a contributing factor to a third (30.5%) of all injury-related deaths in the United States. About 75% of TBIs that occur each year are concussions or other forms of mild TBI. The CDC says an estimated 1.7 million people sustain a TBI annually. Of them:
52,000 die, 275,000 are hospitalized, and 1.365 million, nearly 80%, are treated and released from an emergency department In the U.S. alone, the direct and indirect costs of TBI are estimated at $60 billion.
Incidence of TBI in all industrialized countries is comparable to the United States with estimates ranging from 150 to more than 300 per 100,000. There are approximately 66,000 deaths annually attributed to TBI in Europe.
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 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, and topical wound healing. More information is available at www.oxybiomed.com or www.buydermacyte.com.
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 research and development of the Oxycyte product line 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 companys 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.
end of announcement euro adhoc
Further inquiry note:
Ellen Corliss
Vice President, Corporate Communications
& Investor Relations
Oxygen Biotherapeutics, Inc
2530 Meridian Pkwy, 3rd floor
Durham, NC 27713
Direct Telephone: +1 919 855 2112
Direct Fax: +1 919 806 4417
Email: e.corliss@oxybiomed.com
Branche: Biotechnology
ISIN: US69207P2092
WKN: 10728277
Index: SSIRT
Börsen: New York / Nasdaq
SIX Swiss Exchange / Main Standard