Oxygen Biotherapeutics Submits to FDA Results of Requested Nonclinical Studies
Submission of Data to Address Clinical Hold Major Milestone Toward Reinitiated Studies in U.S.
MORRISVILLE, N.C.--(BUSINESS WIRE)-- Oxygen Biotherapeutics, Inc., (NAS: OXBT) a developer of oxygen-carrying therapeutics, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) results from two series of animal studies designed to address Agency concerns regarding the use of Oxycyte in treating traumatic brain injury (TBI) patients. These studies were conducted to probe both the interactions between Oxycyte and the immune system as well as assess the PFC-based emulsion's potential to increase the risk of intracerebral hemorrhage (ICH). This research was funded as part of a $2.07 million grant that Oxygen Biotherapeutics has with the U.S. Army who is committed to developing treatments for TBI. Submission of these data represents an important step forward in responding to FDA questions and adding US clinical sites to those already participating in the development of Oxycyte.
In the immunocompetency work, mice were challenged with two of the most commonly encountered types of infections in TBI patients - pneumonia and influenza. Results from these studies clearly demonstrated that Oxycyte has little to no impact on the efficient clearance of these pathogens from the body and, presumably, those removed by similar mechanisms. The no adverse event level (NOAEL) for Oxycyte in the pneumonia and influenza experiments was determined to be 7.2 grams per kg. Exposure of mice to Listeria monocytogenes, a model for aggressive blood-borne bacteria that can lead to sepsis resulted in increased mortality following Oxycyte administration. While no NOAEL dose was determined in the Listeria study, the exposure level to Oxycyte in the mice at the NOAEL of the above studies (7.2 grams per kg) is almost ten times higher than that seen in man at the recommended maximum human dose. Additionally, across almost three dozen patients treated with Oxycyte to date, there have been no reports of such an infection, thereby putting the risk of this serious infection in perspective.
Because PFC emulsions are known to cause a transient decrease in platelet numbers in animals and humans the FDA has expressed concerned about TBI patients being at increased risk of de novo ICH or expansion of existing lesions. However, in a widely used rat ICH model, Oxycyte, at doses up to 12 mL/kg had little effect on hemostasis - despite producing the typical 30-40% drop in platelet count. Even more significant was the observation that hemorrhages produced by injecting collagenase into the brain never expanded in size following Oxycyte administration beyond those in the saline control group. In stark contrast, heparin, which was used as a positive control, caused the brain hemorrhage to expand to four times its original size.
"Submission to the FDA of these long-awaited studies represents another important step towards adding the United States to the growing list of countries participating in our current Phase IIb severe TBI trial," stated Dr. Timothy Bradshaw, Oxygen Biotherapeutics' Executive Vice President of Drug Development.
"We look forward to completing the studies requested by the FDA as a condition for lifting the clinical hold on Oxycyte for treating TBI patients and will continue to provide them with data as it becomes available," commented Michael Jebsen, Interim CEO, President and Chief Financial Officer.
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 company's 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 September 17, 2013, and our annual report on Form 10-K filed on June 26, 2013, 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.
Robert Haag, 1-866-976-IRTH (4784)
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