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. -- April 30, 2013
Oxygen Biotherapeutics, Inc. (“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 company’s 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 company’s
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
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