Synthetic Blood Announces Progress With Oxycyte Program In Traumatic Brain Injury

Main Category: Neurology / Neuroscience
Also Included In: Clinical Trials / Drug Trials
Article Date: 13 Dec 2007 - 1:00 PDT

email to a friend   printer friendly   opinions  

Synthetic Blood International, Inc. (OTCBB:SYBD) announced its plan to finalize a Phase IIb clinical trial protocol with Oxycyte™ for the treatment of traumatic brain injury (TBI) at its Scientific Advisory Board (SAB) meeting scheduled for Thursday, December 13, 2007. Oxycyte is Synthetic Blood's proprietary perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.

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 120 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.

Synthetic Blood also announced intentions to name additional members to its SAB at the December 13 meeting. Those candidates under review are primarily located at medical centers that may be involved with Oxycyte trials. Additionally, the SAB plans to develop a strategy for initiating supportive preclinical studies to explore the basic science of Oxycyte's oxygen delivery capabilities for the treatment of damaged brain tissue, and the effects of higher Oxycyte doses than have been used in previous studies, as well as the potential effects of administering second doses of Oxycyte.

"Our Phase IIb trial protocol design was developed to provide what we believe will be definitive results with Oxycyte as a therapeutic treatment for TBI," stated Dr. Bullock. "Positive data from the pilot study in TBI patients demonstrated that Oxycyte was more effective in increasing brain oxygen tension levels and impacting other brain chemistries that contribute to favorable clinical outcomes in TBI patients than breathing either 100 percent or 50 percent oxygen. If we see similar results in the larger patient population, we believe that it is likely that the government may deem Oxycyte immediately useful for battlefield settings."

"We are making headway in our development program with Oxycyte in TBI that will capitalize on the favorable results from our Phase IIa pilot study," said Robert Larsen, Interim President and CEO of Synthetic Blood. "Finalizing the protocol is an important step in the process to prepare for our Phase IIb trial protocol submission to the U.S. Food and Drug Administration."

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 http://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

• Additional
• References
• Citations