Oxygen Biotherapeutics Announces Progress in its Phase IIb Clinical Trial of Oxycyte for the Treatment of Traumatic Brain Injury
Begins second cohort with first patient enrolled in Israel
MORRISVILLE, N.C.--(BUSINESS WIRE)-- Oxygen Biotherapeutics, Inc. (OXBT), (OBI) (NASDAQ: OXBT), today announced enrollment of the first subject in the second cohort of its global Phase IIb clinical trial to investigate the safety and tolerability of Oxycyte® in patients with severe, non-penetrating traumatic brain injury (STOP-TBI). The first patient of the second cohort was enrolled in Israel at the Rambam Health Care Campus (RHCC) - the only Level 1 trauma center in the north of Israel. The RHCCs neurotrauma center treats approximately 200 severe brain injuries annually and is recognized as a teaching center of excellence for the region. The neurotrauma center is led by Dr. Leon Levi who, together with Department of Neurosurgery Chief, Professor Menashe Zaaroor, serve as co-principal investigators in the STOP-TBI trial.
The first cohort, of the three-cohort study, concluded with an independent safety monitoring board recommending, unanimously, advancement to Cohort 2. In addition to the 5 study centers receiving ethics committee approval in Israel, the study is expected to include sites in Switzerland, France and Spain, as well as other countries to be named later.
Dr. Levi, who is Oxygen Biotherapeutics National Advisor in Israel for the study, recently commented, The neurosurgical department at RHCC is proud to be a part of the research with Oxycyte as a treatment for TBI. We look forward to productive work on this important study.
With this first patient, weve officially begun our second cohort in the Phase IIb clinical trial in Israel and Switzerland, stated Michael Jebsen, Interim CEO, President and Chief Financial Officer. Each milestone that moves us towards regulatory approvals for Oxycyte® is a result of the commitment weve made to focus on this critical TBI indication for treatment markets both in the U.S. and internationally, where there are currently no approved treatments for any phase of TBI. We are pleased to be working with the top neurosurgeons and thought leaders in the world who seek advanced methods to treat and prevent critical medical conditions resulting from TBI.
The STOP-TBI trial is a randomized, double-blind, placebo-controlled dose-escalation study of Oxycyte®. The primary objective of the trial is to evaluate the safety and tolerability of Oxycyte® in patients with severe non-penetrating traumatic brain injury. The secondary objective is to assess the potential of Oxycyte® in ameliorating the severity of TBI and represents an opportunity for the collection of placebo-controlled efficacy data, specifically, clinical and functional improvement. Functional status will be measured by the Glasgow Outcome Scale - Extended (GOS-E), a validated tool that helps to assess progress in patient recovery from their injury.
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is developing medical products that efficiently deliver oxygen to tissues in the body. The company has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte® that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke. The company is also developing PFC-based creams and gels for topical delivery to the skin for dermatologic conditions and potentially wound care. In addition, the Company has commercialized its Dermacyte® line of skin care cosmetics for the anti-aging market. Dermacyte is now out-licensed to Valor Cosmetics of Switzerland.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the companys judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, 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 Form 10-Q filed on March 18, 2013, and our annual report on Form 10-K filed on June 26, 2013, as well as other filings with the SEC (SCUR). 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.
Robert Haag, 1-866-976-IRTH (4784)
Source: Oxygen Biotherapeutics, Inc.Copyright Business Wire 2013