Synthetic Blood International, Inc. has 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,” Larsen said.
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.