Oxygen Biotherapeutics Submits to FDA Results of Requested Nonclinical
Submission of Data to Address Clinical Hold Major Milestone Toward Reinitiated
Studies in U.S.
MORRISVILLE, N.C. -- September 23, 2013
Oxygen Biotherapeutics, Inc., (NASDAQ: 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
“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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