COSTA MESA, Calif., Jul 30, 2008 (BUSINESS WIRE) --
Oxygen Biotherapeutics, Inc. OXBO today announced that a
study to be published in the August 2008 edition of the "Journal of
Neurosurgery: Spine" demonstrates that Oxycyte(R) can help reduce
damage caused by oxygen shortages in a spinal cord injury model.
Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen
carrier.
The investigators in the study and authors of the article are
Jason L. Schroeder, M.D., Jason M. Highsmith, M.D., Harold F. Young,
M.D., and Bruce E. Mathern, M.D. All are with the Department of
Neurosurgery, Virginia Commonwealth University Health System in
Richmond, Virginia.
Few therapies have consistently demonstrated effectiveness in
preserving oxygen delivery after spinal cord injury (SCI). The
researchers measured oxygen levels in rats in two studies to establish
a dose response curve. The pressure of oxygen levels dissolved in the
blood in spinal cord injury showed a profound drop from 21.4 to 10.4
mm Hg almost immediately post injury. In the relevant experiment, all
animals that received Oxycyte combined with 100% oxygen showed
significant improvement, with a mean increase in oxygen levels of 23.3
mm Hg. Only one saline-treated animal in the control group showed any
benefit. Oxygen values in the group treated with Oxycyte reached up to
six times the normal level.
"The laboratory investigation suggests that administration of a
perfluorocarbon with the characteristics and performance of Oxycyte
combined with 100% oxygen therapy can reverse tissue oxygen deficit
and holds promise for reducing ischemic injury," said Bruce D. Spiess,
M.D., Professor Anesthesiology and Emergency Medicine, VCURES/VCU Med
Center Richmond, Virginia, and co-chair of the Oxygen Biotherapeutics
Medical Advisory Board.
"Traumatic spine injury is a major cause of long-term disability
for our troops in the war zones as well as 200,000 plus civilian
injuries per year. If we could develop a rapid technique to salvage as
much function as possible immediately after injury, this would be a
major breakthrough in spine trauma. The key to tissue salvage may well
be immediate oxygen delivery to tissues at risk," said Dr. Spiess.
"This is exciting news for Oxygen Biotherapeutics, Inc.," said
company chairman and CEO Chris J. Stern, DBA. "We've always known what
our compound is capable of. Now, this latest research shows the
possibility of yet another indication for treatment with Oxycyte in
addition to those we've previously discussed, potentially broadening
our product portfolio. If this early research translates to humans,
Oxycyte could have a significant impact on the lives of spinal cord
injury victims."
The company provided the Oxycyte to the researchers at no charge
but did not provide any other financial support or sponsorship.
The company also said that it is in continuing, positive
communication with the FDA regarding the protocol for its proposed
Phase IIb clinical trial of Oxycyte in traumatic brain injury. "The
FDA is working with us and reviewing all our data," said Dr. Richard
Kiral, company president, COO, and chief scientific officer. "They're
asking questions and we're providing answers. The agency is doing
their work very diligently and we will continue to invest the time it
takes to bring this process to the outcome we all want. It is in
everybody's interest to establish a fully-reviewed trial protocol that
can lead our product to market."
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is dedicated to commercializing
innovative pharmaceuticals and medical devices in the field of oxygen
therapeutics and continuous substrate monitoring. The Company has
under development a perfluorocarbon therapeutic oxygen carrier and
liquid ventilation product and an implantable glucose sensor. These
products are based upon core technologies that include biomedical
applications for PFCs and medical and industrial applications for
biosensors. Each of the product candidates is designed with advantages
over currently marketed products in major markets including acute
respiratory distress syndrome, stroke, myocardial infarction, surgery,
trauma, malignant tumors and diabetes. For further information, visit
www.oxybiomed.com.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by
Oxygen Biotherapeutics, Inc. that involve risks and uncertainties and
reflect the company's judgment as of the date of this release. These
statements include references to potential applications of Oxycyte in
treating spinal cord injuries, the potential benefits of Oxycyte,
forecasts of the company's prospects for a product portfolio and
planned clinical trials using Oxycyte. Actual events or results may
differ from the company's expectations. There can be no assurance that
any future research using Oxycyte in spinal cord injury treatment will
be undertaken or that if done will be successful or that the results
of the reported animal study will have any similar outcome in humans.
Nor can there be any assurance that the FDA will approve the company's
proposed Phase IIb clinical trial in traumatic brain injury, that if
conducted any such trial will be successful, that Oxycyte will be
approved for market by the FDA, or that if approved will gain market
acceptance. Additional information concerning these and other risk
factors affecting Oxygen Biotherapeutics, Inc.'s business can be found
in the company's public periodic filings with the Securities and
Exchange Commission, which are available via www.oxybiomed.com. Oxygen
Biotherapeutics, Inc. 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.
SOURCE: Oxygen Biotherapeutics
Abe Wischnia & Associates
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