Plans to Strengthen Scientific Advisory Board
COSTA MESA, Calif.--(Business Wire)--Synthetic Blood International, Inc. (OTCBB:SYBD) today announced
its plan to finalize a Phase IIb clinical trial protocol with
Oxycyte(TM) for the treatment of traumatic brain injury (TBI) at its
Scientific Advisory Board (SAB) meeting scheduled for Thursday,
December 13, 2007. Oxycyte is Synthetic Blood's proprietary
perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
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 120 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.
Synthetic Blood also announced intentions to name additional
members to its SAB at the December 13 meeting. Those candidates under
review are primarily located at medical centers that may be involved
with Oxycyte trials. Additionally, the SAB plans to develop a strategy
for initiating supportive preclinical studies to explore the basic
science of Oxycyte's oxygen delivery capabilities for the treatment of
damaged brain tissue, and the effects of higher Oxycyte doses than
have been used in previous studies, as well as the potential effects
of administering second doses of Oxycyte.
"Our Phase IIb trial protocol design was developed to provide what
we believe will be definitive results with Oxycyte as a therapeutic
treatment for TBI," stated Dr. Bullock. "Positive data from the pilot
study in TBI patients demonstrated that Oxycyte was more effective in
increasing brain oxygen tension levels and impacting other brain
chemistries that contribute to favorable clinical outcomes in TBI
patients than breathing either 100 percent or 50 percent oxygen. If we
see similar results in the larger patient population, we believe that
it is likely that the government may deem Oxycyte immediately useful
for battlefield settings."
"We are making headway in our development program with Oxycyte in
TBI that will capitalize on the favorable results from our Phase IIa
pilot study," said Robert Larsen, Interim President and CEO of
Synthetic Blood. "Finalizing the protocol is an important step in the
process to prepare for our Phase IIb trial protocol submission to the
U.S. Food and Drug Administration."
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.
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
Copyright Business Wire 2007
