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.
Synthetic Blood International Inc.
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Source: Synthetic Blood International Inc.