COSTA MESA, Calif.--(BUSINESS WIRE)--Synthetic Blood International, Inc. (OTCBB:
SYBD -
News) today announced its
near-term development strategy for Oxycyte
™.
The Company finalized its Phase IIb Oxycyte clinical trial protocol for
the treatment of traumatic brain injury (TBI), and plans to initiate
three pre-clinical animal studies in sickle cell disease, spinal cord
injury and stroke in the first half of 2008. Oxycyte is the Company
’s
proprietary perfluorocarbon (PFC) therapeutic oxygen carrier and blood
substitute.
These Oxycyte development initiatives were determined at the Company’s
Scientific Advisory Board (SAB) meeting conducted last week. Synthetic
Blood also announced its intention to invite six to eight physicians to
join the SAB in a move to broaden its specialties. The SAB candidates
are expected to be primarily located at medical centers that may be
involved with Oxycyte trials.
“We have taken a major step toward FDA
submission of a Phase IIb protocol in TBI,”
said Robert Larsen, Interim President and CEO of Synthetic Blood. “Further,
favorable data from our Phase IIa pilot clinical study in TBI
demonstrated Oxycyte’s ability to provide
oxygen transport to tissues immediately after injury. Based on these and
other study data, we believe that Oxycyte could significantly reduce
permanent damage and improve recovery outcomes in additional indications.”
Bruce Spiess, M.D., Virginia Commonwealth University Professor and
Vice-Chairman of Anesthesiology, Chief of Cardiothoracic Anesthesia and
Director of the Research Department of Anesthesiology, and Synthetic
Blood’s SAB Chairman, stated, “We
plan to study the effects of repeat dosing with Oxycyte, which could
provide additional clinical benefits. The time course of brain improved
oxygenation occurs immediately after Oxycyte administration and lasts
for approximately 18 to 24 hours. However, the potential for neuronal
death can continue for as long as seven to 10 days after initial injury.
Repeat dosing, if safe without any adverse side effects, could greatly
increase the oxygenation of the tissue involved.”
Previous animal studies have indicated that early intervention with
Oxycyte helps to prevent the destruction of nerve cells in spinal cord
injuries and provides oxygen to brain tissues in stroke.
Sickle cell disease is a genetic condition caused by abnormal hemoglobin
that crystallizes under low oxygen concentrations. This change leads to
cells becoming misshapen and unable to move through the
microcirculation. Sickle cell disease currently affects an estimated
100,000 people in the United States, as many as 50 million people in the
African sub-Sahara, as well as large populations in India.
Stroke is the third leading cause of death in the U.S. and accounts for
more than 162,000 deaths in the U.S. each year. According to the
American Heart Association, 700,000 Americans each year experience a new
or recurrent stroke. Stroke is the number one cause of long-term
Disability among Americans.
Spinal Cord Injury is damage to the spinal cord that results in a loss
of function such as mobility or feeling and can result in paralysis.
Spinal cord injury affects approximately 250,000 individuals in the
U.S., increasing at a rate of approximately 11,000 new cases per year.
About the Phase IIb trial
The proposed double blind, placebo-controlled Phase IIb trial is
designed to compare Oxycyte with present-day advanced therapies in TBI,
and is expected to enroll 100 to 150 patients at six major neurosurgery
centers. The trial protocol was prepared by M. Ross Bullock, M.D.,
Ph.D., of the University of Miami Miller School of Medicine, Department
of Neurosurgery. Dr. Bullock was a principal investigator on Synthetic
Blood’s Phase IIa pilot study with Oxycyte in
TBI and currently serves on the Company’s SAB.
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 a
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.
Safe Harbor Statement The Private Securities Litigation Reform
Act of 1995 provides a safe harbor for forward looking information made
on the Company’s behalf. All statements other
than statements of historical facts which address the Company’s
expectations of source of capital or which express the Company’s
expectations for the future with respect to financial performance or
operating strategies, can be identified as forward-looking statements.
Such statements made by the Company are based on knowledge of the
Environment in which it operates, but because of the factors previously
listed, as well as other factors beyond the control of the Company,
actual results may differ materially from the expectations expressed in
the forward-looking statements.
Contact:Company Contact:
Synthetic Blood International Inc.
Joan Mahan, 800-809-6054
or
Investor Contacts:
Lippert/Heilshorn & Associates, Inc.
Jody Cain or Brandi Floberg, 310-691-7100
jcain@lhai.com
bfloberg@lhai.com
Source:
Synthetic Blood International Inc.