Product Pipeline

The INTERCEPT Blood System® for Platelets and Plasma
The INTERCEPT Blood System for platelets and plasma is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens, such as viruses, bacteria, and parasites that may be present in donated blood intended for transfusion. The platelet and plasma systems inactivate pathogens using the same illumination device, process and active compound. The INTERCEPT Blood System for platelets and plasma has received CE mark approvals. Over 450,000 INTERCEPT platelet and plasma kits have been shipped to date, and the technology has been used clinically in Europe, Russia, the Middle East, Asia and in selected countries in other regions around the world. The platelet and plasma systems are not yet approved for sale in the United States.
The INTERCEPT Blood System for Red Blood Cells
A two-armed Phase III clinical trial for red cells was halted in 2003 when antibodies to treated red blood cells were detected in one patient in the chronic arm of the trial. We evaluated the antibodies detected in the trial and developed process changes that may greatly diminish the likelihood of antibody reactivity in red blood cells treated with this modified process. We announced several findings related to these evaluations and developments in late 2004 and 2005 at several scientific and trade association meetings. We also disclosed that upon unblinding of the Phase III data, enpoints within the acute arm of the trial had been met. Based on these findings, we have conducted additional preclinical and Phase I human clinical trials in the U.S. to test modifications to the original process. In the fourth quarter of 2008, we initiated a small Phase I clinical trial in healthy volunteers at two sites in the U.S. with a modified process, which was completed early in 2010. We do not expect to initiate a Phase III clinical trial for our red blood cell system until we have secured additional financing.
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