FDAnews
www.fdanews.com/articles/84708-synthetic-blood-expects-oxygen-carrier-trial-to-resume

SYNTHETIC BLOOD EXPECTS OXYGEN CARRIER TRIAL TO RESUME

February 20, 2006

Synthetic Blood International announced it expects to initiate its Oxycyte Phase II sickle cell anemia trial in the second quarter of 2006, subject to the availability of future funding. The company is developing its proprietary perfluorocarbon, Oxycyte, as a therapeutic oxygen carrier.

Trial initiation was delayed after the FDA sent a letter placing the trial on clinical hold for protocol revisions. Synthetic Blood said it intends to work with FDA officials to satisfy the necessary requirements.

"Based on discussions with this trial's clinical investigators, we are confident in our ability to respond to issues raised by the FDA. We plan to quickly submit a revised protocol and consent that will enable us to proceed with this important study," said Robert Nicora, Synthetic Blood President and CEO.

Sickle cell anemia is a genetic condition that affects approximately 72,000 people in the United States, and more than 100 million people worldwide.