Message #29 From:
Jason Date: March 6, 2008 09:41:57 PM
Office of Naval Research Provides $3.5 Million in New Grants for Clinical Research Involving Synthetic Blood International's Oxycyte(R)
Synthetic Blood International, Inc. (OTCBB:SYBD) announced today that
Virginia Commonwealth University Reanimation Engineering Shock Center
(VCURES) has received four separate research grants from the Office of
Naval Research (ONR) totaling $3,517,696. These four grants will support
pre-clinical research studies involving Oxycyte®,
a product of Synthetic Blood International. Oxycyte is the company’s
perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
Bruce Spiess, M.D., Virginia Commonwealth University Professor of
Anesthesiology and Emergency Medicine, Director of Research
(Anesthesiology) and Director of VCURES said, “These
grants will allow us to expand upon the previous studies which showed
that early intervention with Oxycyte can prevent the destruction of
nerve cells, brain tissue in a number of conditions including
decompression illness and gas embolism.”
Approximately $1.2 million (over 3 years) will be utilized in ongoing
studies of perfluorocarbon emulsions in the treatment of severe
decompression sickness (DCS). DCS occurs in dive accidents, mine
workers, high altitude and space flight, and is a potential complication
of rescue from a disabled submarine (DISSUB). This grant supports
on-going work at VCURES which has demonstrated Oxycyte’s
significantly improved oxygen delivery to tissues and increased removal
of nitrogen from the body in past experiments.
A $1.6 million grant (over 3 years) was made for support of research
into Oxycyte’s ability to treat/prevent organ
damage from arterial gas embolism (AGE). AGE is a potential result of
DCS but also occurs during a number of surgical procedures including
cardiac surgery, orthopedic-joint replacement, gynecologic surgery, and
neurosurgery.
A $300,000 dollar grant (over two years) was made to sponsor a
post-doctoral candidate to work in the microcirculation laboratories of
VCURES supporting research in AGE, DCS, as well as other work in
traumatic brain injury (TBI). This support will extend the effectiveness
of other PhD personnel already involved in basic science investigations
of critical oxygen delivery to tissues with and without the presence of
Oxycyte.
The fourth grant was for approximately $300,000 to develop pilot studies
into the effectiveness of Oxycyte in treating traumatic brain injury
secondary to a blast. Blast injury is the largest single cause of
mortality and long term morbidity for coalition troops stationed in Iraq
and Afghanistan. The VCURES work in blast injury will carefully dovetail
with other Oxycyte research in TBI. Prior work from VCURES has shown PFC
to be effective in treating TBI from isolated blunt closed head injury
and blast, as a mechanism for brain injury, may well have similarities
as well as differences from isolated blunt contusive brain injury. The
goals of the researchers are to not only investigate the basic science
but also to rapidly transition any medical advantages to the troops as
soon as possible. Data from all four of these grants will provide basic
science backing to other potential applications for this unique oxygen
therapeutic in acute critical illness. These four grants together
demonstrate the commitment that the DOD and ONR has to finding solutions
to combat casualty care as well as interest in the third generation PFC –
Oxycyte.
“These grants to VCURES following the
announcement last week of a $1.9 million grant from the Department of
Defense to further study Oxycyte in treating traumatic brain injury are
a strong indication that the military sees the potential benefits of
Oxycyte in preventing or arresting brain damage,”
said Robert Larsen, president and CEO of Synthetic Blood, International. “We
are hopeful that these additional funds will lead to results that can
speed us on the road to approval by the FDA.”
Said Dr. Spiess, who also is the co-chairman of Synthetic Blood’s
Scientific Advisory Board, “We’re
eager to put these funds to work to help lead to treatments that improve
patient outcomes in these critical areas.”
Synthetic Blood International plans to begin a Phase IIb trial of
Oxycyte in 200 TBI patients in the second quarter of this year.
About Synthetic Blood International
Synthetic Blood International is dedicated to commercializing innovative
pharmaceuticals and medical devices in the field of oxygen therapeutics
and continuous substrate monitoring. The Company has under development
an oxygen therapeutic/blood substitute and a 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.sybd.com.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by
Synthetic Blood International, Inc. that involve risks and uncertainties
and reflect the company's judgment as of the date of this release. These
statements include commencement of clinical trials, planned patient
enrollment, and other research studies involving Oxycyte. Actual events
or results may differ from Synthetic Blood International, Inc.'s
expectations. There can be no assurance that the planned research
studies and clinical trials will be conducted in the expected time frame
or that any such studies and trials will be successful. Additional
information concerning these and other risk factors affecting Synthetic
Blood International, Inc.'s business can be found in the company's
public periodic filings with the Securities and Exchange Commission,
which are available via www.SYBD.com.
Synthetic Blood International, 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.
for Synthetic Blood International, Inc. Abe Wischnia & Associates Abe
Wischnia, 619-795-2345
