Healthcare Industry News: BD
News Release - February 8, 2008
Synthetic Blood Announces Medical Advisory Board Meeting Results, New Additions to BoardCOSTA MESA, Calif.--(HSMN NewsFeed)--Synthetic Blood International, Inc. (OTCBB:SYBD ) today announced that in a February 1st meeting its Medical Advisory Board (MAB) provided recommendations for proceeding with the clinical development of the Company’s perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute Oxycyte™. Synthetic Blood also announced the addition of Derek Ralph Brinster, M.D., and Christine Stowe Rinder, M.D., to its MAB, bringing total membership to 13.
The MAB pointed to new preclinical studies in second dosing of Oxycyte, sickle cell disease, spinal-cord injury, and continued support of the U.S. Navy’s interest in decompression sickness, commonly know as bends, as valuable clinical information in supporting future marketing approval of Oxycyte. As the next step in traumatic brain injury, a protocol for a 100-patient (67 treated with Oxycyte and 33 given a control), double-blind Phase IIb trial was approved and will be submitted to the U.S. Food and Drug Administration (FDA) following completion of Phase IIa study statistical analysis. The MAB concluded that six to 10 medical centers would be necessary to complete this Phase IIb study in 2008. Five centers have already been proposed and are being reviewed to determine their ability to conduct the specialized testing needed to measure blood oxygen flow to the injured brain.
“We are exceptionally pleased with our MAB’s enthusiasm for Oxycyte and its focus on determining the next steps to evaluate Oxycyte’s potential in numerous applications in which oxygen delivery to diseased and injured tissue can benefit patient recovery and reduce long-term damage,” said Robert Larsen, Interim President and CEO of Synthetic Blood International. “We thoroughly discussed the success and failures of PFC oxygen therapeutics and the advantages of our Oxycyte formulation.”
Nine of the 13 MAB members attended the meeting and heard presentations from two guest speakers from Virginia Commonwealth University Reanimation Engineering Shock Center (VCURES). Dr. Ivo Torres discussed measurement of oxygen transport in microcirculation and Dr. Imo Aisiku addressed the sickle cell program.
Background on MAB Additions
Dr. Brinster is an assistant professor of surgery and director of the Thoracic Aortic Surgery program, Division of Cardiothoracic Surgery at Virginia Commonwealth University Medical Center. Prior to that, he was an assistant instructor of surgery at the University of Pennsylvania School of Medicine. He has authored 18 articles and numerous book chapters in his field. Dr. Brinster received his medical degree at the University of Pennsylvania Medical School.
Dr. Rinder, an associate professor at the Department of Anesthesiology at Yale University’s School of Medicine, received her degree from the University of Vermont College of Medicine and has published more than 39 articles, written 19 chapter books and is the editorial reviewer for seven medical journals in her field. Her main research interest is cellular effects of extra-corporeal circulation.
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.
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.
Source: Synthetic Blood International
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.