Synthetic Blood receives FDA notice delaying Oxycyte phase 2 sickle cell anemia trial

By Lisa Kerner

Erie, Pa., Feb. 17 - Synthetic Blood International, Inc.'s Oxycyte phase 2 sickle cell anemia trial has been delayed due to the Food and Drug Administration's decision to place the trial on clinical hold for protocol revisions, according to a company news release.

Synthetic Blood said it intends to "actively and diligently" work with FDA officials to satisfy the necessary requirements and plans to begin the trial in the second quarter of 2006, subject to the availability of funding.

"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," president and chief executive officer Robert Nicora said in the release.

"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."

Synthetic Blood filed an amendment to its Investigational New Drug application with the FDA in December to begin a 20-patient, proof-of-concept phase 2 trial in patients with sickle cell anemia at Virginia Commonwealth University.

According to the release, the genetic condition sickle cell anemia affects roughly 72,000 people in the United States and more than 100 million people worldwide.

Synthetic Blood is based in Costa Mesa, Calif., where it commercializes pharmaceuticals and medical devices for the field of oxygen therapeutics and continuous substrate monitoring.

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