Oxygen Biotherapeutics Announces It is Set to Begin Enrolling Patients in the Second Cohort of Its STOP-TBI Clinical Trial in Israel
MORRISVILLE, N.C.--(BUSINESS WIRE)-- Oxygen Biotherapeutics, Inc. (OXBO) (OBI) (NASDAQ: OXBT), today announced the initiation of the second cohort of its Phase IIb clinical trial to investigate the safety and tolerability of Oxycyte in patients with severe, non-penetrating traumatic brain injury (STOP-TBI). The second cohort begins officially with the activation of the first of five planned sites in Israel. This trial site will receive its first shipment of Oxycyte this week and can immediately begin enrollment.
Resuming enrollment in the second cohort of our TBI trial is a critical milestone in the development of Oxycyte, said Michael Jebsen, President and Chief Financial Officer of OBI. We have spent the last year focused on securing long-term supply of clinical trial material and retaining a contract research organization with the ability to effectively manage an international clinical trial. Bringing Oxycyte to market as a treatment for acute ischemic conditions, such as TBI, remains the top priority of OBI.
The STOP-TBI trial is a randomized, double-blind, placebo-controlled dose-escalation study in which a single intravenous administration of Oxycyte is given to patients in conjunction with supplemental oxygen. 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. This study is designed to enroll an additional 68 subjects at up to 18 sites in Israel, Switzerland, France and Spain.
TBI is the leading cause of death and disability in children and young adults in the United States. Approximately 1.7 million Americans are treated for TBI each year and an estimated 5.3 million people are living with permanent TBI-related disability. Currently, there is no drug approved to directly treat any phase of TBI or the associated medical complications.
Oxycyte is a sterile, non-pyrogenic perfluoro(t-butylcyclohexane) emulsion product. As a class of compounds, perfluorocarbons have been shown capable of dissolving large amounts of gases (e.g., oxygen, carbon dioxide) based on simple concentration gradients. In TBI patients, Oxycyte circulates in the blood to the lungs where the high concentrations of supplemental oxygen allow for the loading of the emulsion particles with this life-saving gas. The nanoparticle size (200-300nm) of the average Oxycyte emulsion particle, roughly 40 times smaller than a red blood cell, allows the particles to migrate through damaged capillary beds into ischemic tissues where the oxygen is then unloaded via passive diffusion.
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 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 Form 10-Q filed on September 19, 2012, and our annual report on Form 10-K filed on July 24, 2012, as well as other filings with the SEC. 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.
Oxygen Biotherapeutics, Inc.
Ellen Corliss, 919-855-2112
SVP, Investor Relations & Corporate Communications
Source: Oxygen Biotherapeutics, Inc.Copyright Business Wire 2013