Synthetic Blood International, Inc., subject to availability of future funding, expects to initiate its Oxycyte Phase II sickle cell anaemia trial in the second quarter of 2006. Trial initiation has been delayed based on the company's receipt of a letter from the US FDA placing the trial on clinical hold for protocol revisions. Synthetic Blood intends to actively and diligently work with FDA officials to satisfy the necessary requirements, the company announced here.

"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. "We are committed to advancing our Oxycyte clinical program. We continue to believe that Oxycyte represents a safe and effective means of delivering oxygen to patients such as those suffering from sickle cell anemia, in which no direct treatment currently exists," he added.

According to the company release, in December 2005, Synthetic Blood filed an amendment to its Investigational New Drug (IND) application with the FDA to initiate a 20-patient, Phase II proof-of-concept trial in sickle cell anaemia to be conducted at Virginia Commonwealth University. Sickle cell anaemia is a genetic condition that affects approximately 72,000 people in the United States, and more than 100 million people worldwide.