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. -- July 1, 2013
Oxygen Biotherapeutics, Inc., (“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 RHCC’s 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, we’ve 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
we’ve 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 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 March 18, 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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