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Favrille Reports Fourth Quarter and Year End 2005 Financial ... - PR Newswire (press release)

Recent Highlights * Completed Enrollment in Pivotal Phase 3 Clinical Trial of FavId. Favrille completed enrollment in its Phase 3 clinical trial of FavId in January 2006. The Company initiated the trial in July 2004 with an enrollment target of 342 eligible patients. The randomized, double-blind, placebo-controlled registration trial is designed to evaluate FavId following Rituxan(R) therapy for the treatment of follicular B-cell NHL. The Company anticipates an analysis of the secondary endpoint, response improvement, during the fourth quarter of this year. According to Favrille's Special Protocol Assessment from the U.S. Food and Drug Administration (FDA), a clinically meaningful response improvement may serve as the basis for an accelerated approval filing. Analysis of the primary endpoint of the trial, time to disease progression, is expected during the second half of 2007. * Received FDA Fast Track Designation for FavId. Favrille also announced in January 2006 that it has received Fast Track designation from the FDA for FavId. Fast Track designation is granted for a new drug that is intended to treat a serious or life-threatening condition and demonstrates the potential to address an unmet medical need and as a result is eligible for priority review by the FDA. This action - More available

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