COSTA MESA, Calif.--(BUSINESS WIRE)--Synthetic Blood International, Inc. (OTCBB:SYBD - News) announced today that the company is currently fulfilling additional data requirements posed by the U.S. Food & Drug Administration (FDA) in connection with the protocol for its planned Phase II-b clinical trial of Oxycyte® in Traumatic Brain Injury (TBI) patients. The company expects to have the additional data submitted to the agency by the end of May. Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
“These are issues that relate to an earlier clinical trial where apparently the data that the FDA had was incomplete. We’re providing that information and it is still our goal to begin enrolling and treating TBI patients this summer,” said company chairman and CEO Chris J. Stern, DBA.
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.
Location Changed for Special Shareholders Meeting
The company announced today that the location of the special shareholders meeting has been changed in order to accommodate the larger than expected number who have indicated they plan to attend. The new location is
Hilton Irvine/Orange County Airport
18800 MacArthur Blvd.
Irvine, CA 92612
The hotel is located directly across the street from the Orange County/John Wayne Airport at the corner of Douglas & MacArthur.
Special Shareholders Meeting to be Webcast Live.
The special shareholders meeting will be available to all interested parties via a live webcast. Login details and the link for the webcast will be posted on the company website prior to the meeting.
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.
Abe Wischnia & Associates
Abe Wischnia, 619-795-2345
Source: Synthetic Blood International, Inc.