Message #36 From:
NewsBot Date: April 14, 2008 09:36:00 PM
Synthetic Blood International, Inc. Announces Filing of Protocol for Phase II-b Oxycyte Clinical Trial
Synthetic Blood International, Inc. Announces Filing of Protocol for Phase II-b Oxycyte Clinical Trial
Synthetic Blood International, Inc. (OTCBB:SYBD) today announced that it
has filed a clinical protocol with the U.S. Food & Drug Administration
(FDA) for its planned Phase II-b clinical trial of Oxycyte®
in Traumatic Brain Injury (TBI) patients. Oxycyte is the Company's
perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
The company’s planned multi-center,
double-blind, placebo-controlled study would enroll up to 300 patients.
200 patients will be allowed for enrollment through a recently approved
$1.9 million grant from the United States Department of Defense to M.
Ross Bullock, M.D., Ph.D., of the University of Miami Miller School of
Medicine, Department of Neurosurgery. Dr. Bullock is the principal
investigator for the planned Phase II-b clinical trial. The company
plans to do an interim analysis after enrolling 100 patients and then
may elect to enroll up to 300.
“Assuming the FDA approves the protocol, our
goal is to begin enrolling and treating TBI patients this summer,”
said company chairman and CEO Chris J. Stern, DBA. “Everyone
has worked so hard in getting this protocol done. It is even more
exiting that part of this study will be financed by a Department of
Defense grant. One of our researchers always says, ‘Oxycyte
will bring patients with TBI back to the taxpayer base.’
We hope to help save as many patients as we possibly can from ending up
in a severe state just because they lacked oxygen in tissue after an
injury.”
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 predictions about the expected commencement of
clinical trials in Traumatic Brain Injury patients and about the
potential benefits of Oxycyte. Actual events or results may differ from
Synthetic Blood International, Inc.'s expectations. There can be no
assurance that the FDA will approve the Phase II-b treatment protocols
as submitted, that the clinical trials will commence in the expected
time frame or at all, that the required number of patients will be
enrolled, that any trials will meet their endpoints, or that Oxycyte or
any company product will be approved by the FDA for any indications.
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.
