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Vitex R&D, business developments

This article was originally published in The Gray Sheet

Executive Summary

Data safety monitoring board clears manufacturer to continue Phase III trial of Inactine pathogen inactivation system to treat red blood cells under an acute-only indication. In 2003, the firm stopped a Phase III trial in red blood cells that supported a chronic transfusion claim, citing problems with antibody formation in sickle cell anemia patients. The firm is seeking shareholder approval for a merger agreement with Panacos Pharmaceuticals...

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Pathogen inactivation trial suspended

Vitex "temporarily" halts patient enrollment in a Phase III study exploring use of its Inactine pathogen inactivation system with red blood cells for an acute-only indication. The decision to suspend enrollment comes a little over a month after a data safety monitoring board cleared the trial despite antibody problems found in Vitex' earlier Phase III trial, which supported a chronic infusion claim (1"The Gray Sheet" Oct. 18, 2004, In Brief). The latter trial was halted a year ago. The acute-only study was suspended because of one patient's immune response to Inactine-treated red cells, Vitex says. Antibody issues also have posed hurdles to clinical development of Baxter/Cerus' Intercept...

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