Cerus Pathogen Inactivation Trial Delay Alters Landscape For Vitex, Navigant
This article was originally published in The Gray Sheet
Executive Summary
Uncertainty over Baxter/Cerus' Intercept red blood cell pathogen reduction program may benefit competitor Vitex, which is pursuing the same indication for its Inactine device
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Cerus evaluates Intercept
Firm's analysis of U.S. Phase III data is ongoing after thrombotic thrombocytopenic pupura (TTP) patients receiving plasma treated with the pathogen reduction system - meant to protect against infectious disease transmission - showed a statistically significant greater number of cardiac disorders than those receiving conventional plasma (1"The Gray Sheet" Sept. 8, 2003, p. 14). Despite the safety data concerns, the multi-center, randomized trial, which included 35 TTP patients, showed that Intercept met its primary and secondary efficacy endpoints, with 82% of Intercept patients and 89% of controls achieving remission within 30 days. Cerus notes it is reviewing "strategy and timing" for regulatory submissions...
Cerus evaluates Intercept
Firm's analysis of U.S. Phase III data is ongoing after thrombotic thrombocytopenic pupura (TTP) patients receiving plasma treated with the pathogen reduction system - meant to protect against infectious disease transmission - showed a statistically significant greater number of cardiac disorders than those receiving conventional plasma (1"The Gray Sheet" Sept. 8, 2003, p. 14). Despite the safety data concerns, the multi-center, randomized trial, which included 35 TTP patients, showed that Intercept met its primary and secondary efficacy endpoints, with 82% of Intercept patients and 89% of controls achieving remission within 30 days. Cerus notes it is reviewing "strategy and timing" for regulatory submissions...
Navigant Pathogen Inactivation System Catching Up With Cerus, Vitex
Navigant Biotechnologies is dedicating $10 mil. in 2004 to the development of its Mirasol riboflavin-based pathogen reduction technology (PRT) for platelets and red blood cells