Oxygen Biotherapeutics Engages PPD to Execute Remainder of Phase IIb
Clinical Trial to Evaluate the Safety and Tolerability of Oxycyte® in Severe
Traumatic Brain Injury
MORRISVILLE, N.C. -- November 20, 2012
Oxygen Biotherapeutics, Inc. (“OBI”) (NASDAQ: OXBT), announced today that it
is partnering with Pharmaceutical Product Development, LLC (PPD), a global
contract research organization, to resume and complete OBI’s STOP-TBI (Safety
and Tolerability of Oxycyte in Patients with Severe non-Penetrating Traumatic
Brain Injury) Phase II-b clinical trial.
“The development of Oxycyte® as a potential breakthrough therapy for severe
traumatic brain injury remains the top priority of this company, and for the
past 12 months we have remained committed to resuming enrollment in our
clinical trials. Engaging a qualified CRO is a critical step in getting trial
sites back up and running and open for enrollment by year-end,” said Michael
Jebsen, President and Chief Financial Officer of OBI.
OBI completed the first cohort of a planned three cohort dose escalation
study. Based on unblinded review of safety data from the 11 enrolled patients,
the Data Safety Monitoring Board (DSMB) unanimously approved initiating Cohort
2. Cohorts 2 and 3 will enroll 18 subjects each with the DSMB reviewing safety
data at the end of each cohort. An additional 50 patients with severe TBI will
be treated at the highest dose approved by the DSMB. The company expects the
trial to be completed in late 2015.
The primary objective of the trial is to evaluate the safety and tolerability
of a single administration 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 (GOS-E), a validated tool that helps to assess progress in
patient recovery from their injury.
Dr. Timothy Bradshaw, Executive Vice President of Drug Development at OBI,
stated that, “We are pleased to be working with PPD as our CRO to oversee the
completion of this critical trial. We selected PPD for their global reach and
expertise conducting trials in which critically injured subjects are
identified and managed in an emergency or trauma setting. They have presented
a great operational plan for ensuring the successful completion of the study.
In addition, PPD has medical staff with therapeutic expertise in neurotrauma.
Our focus now is getting sites ready to enroll patients.”
OBI believes this challenging goal is achievable because many of the clinical
investigators who participated in the first cohort have expressed enthusiasm
for beginning the second cohort. The company has already begun making the
necessary regulatory submissions to Ethics Committees in Israel and plans on
initiating the same process in Switzerland shortly. In an effort to expedite
enrollment, the study will also be expanding into additional countries, adding
sites as the need arises. The current budget allows for up to four countries
and 18 sites to be included if necessary. Importantly, continuity from the
first cohort will be provided for as Dr. Michael Reinert, a noted neurosurgeon
in Switzerland will remain as the lead principal investigator.
Oxycyte is a sterile, milky white, sub-micron (median diameter of 200-250 nm)
perfluorocarbon (PFC) emulsion intended for intravenous injection. It contains
two key ingredients, perfluoro(t-butylcyclohexane) and egg yolk phospholipids
(an emulsifier), along with several minor ingredients dispersed in water.
Research has shown that PFCs can dissolve and release large amounts of gases,
including oxygen and carbon dioxide. When formulated and delivered as an
intravenous emulsion, PFCs have been shown to enhance the oxygenation of
PPD is a leading global contract research organization providing drug
discovery, development and lifecycle management services. Their clients and
partners include pharmaceutical, biotechnology, medical device, academic, and
government organizations. With offices in 44 countries and more than 11,000
professionals worldwide, PPD applies innovative technologies, therapeutic
expertise and a commitment to quality to help clients and partners accelerate
the delivery of safe and effective therapeutics and maximize the returns on
their R&D investments.
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.
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 the clinical study, 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 &
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