Favrille Announces Data Cutoff for Phase 3 Registration Trial of Specifid; Data Analysis and Unblinding Expect...(team is working diligently to gather the...),Health

Favrille initiated its Phase 3 randomized, placebo-controlled, double-blind registration trial of Specifid for follicular B-cell NHL in July 2004. The Company completed enrollment in January 2006 with 349 patients randomized into the trial in a span of 18 months. The trial was open to both treatment-naive and previously treated patients, ultimately enrolling a much larger treatment-naive population (78%). Patients were randomized at a one-to-one ratio to receive either Specifid or placebo following a standard course of Rituxan. A total of 45 patients came off study and were permanently censored for reasons other than disease progression, 28 (8%) because Specifid was not produced and 17 (5%) for a variety of other reasons. The trial was conducted at 67 centers in the U.S. under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA). Specifid was also granted Fast Track status by the FDA in January 2006.

In October 2007 an independent Data Monitoring Board (DMB) conducted an administrative analysis of the unblinded control arm in the Phase 3 trial. The objective of this analysis, conducted in agreement with the FDA, was to assess the behavior of disease progression in the control arm in order to help determine the duration of follow-up needed prior to unblinding the trial. The outcome of this DMB analysis supported the rationale for the timing of data cutoff.

About Specifid

Specifid (mitumprotimut-T, formerly FavId) is a personalized, active immunotherapy designed to stimulate a patient's immune system to mount a specific and sustained response to the patient's cancer. Specifid is based upon a recombinant protein, called idiotype (Id), which is derived from genetic material obtained from a patient's own tumor, then conjugated to keyhole limpet hemocyanin (KLH), a protein commonly used
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