FDAnews
www.fdanews.com/articles/81393-synthetic-blood-to-accelerate-phase-ii-development-of-oxycyte

SYNTHETIC BLOOD TO ACCELERATE PHASE II DEVELOPMENT OF OXYCYTE

October 4, 2005

Synthetic Blood International plans to initiate Phase II trials with its proprietary perfluorocarbon (PFC) blood substitute and therapeutic oxygen carrier, Oxycyte, in patients with traumatic brain injury and with sickle cell anemia. The company expects to complete both clinical trials and report trial data before the end of the year.

In August, Synthetic Blood submitted an amendment to the company's investigational new drug application (IND) with the FDA to initiate a Phase II proof-of-concept study to evaluate the safety and biological effects of Oxycyte in patients with traumatic brain injury. The primary purpose of this study will be to demonstrate Oxycyte's ability to increase brain oxygen tension and favorably affect other brain chemistries that impact clinical outcome in patients suffering severe head injury. Additionally, the study will further assess the safety of Oxycyte when given by intravenous infusion.

The company also plans to file an amendment to its Oxycyte IND application to initiate a Phase II pilot study in patients suffering from sickle cell anemia, a genetic condition that affects approximately 72,000 people in the U.S. The company has already identified clinical sites for this trial, and expects to initiate and report results from the study before the end of 2005.