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Favrille Provides Update on Timing of Analysis from Pivotal Phase 3 Clinical Trial; Reports Third Quarter 2007 Financial Results
Date:10/25/2007

Primary Analysis of Pivotal Trial to Be Available No Later Than July 2008

SAN DIEGO, Oct. 25 /PRNewswire-FirstCall/ -- Favrille, Inc. (Nasdaq: FVRL), a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, announced that an independent Data Monitoring Board (DMB) was recently convened to assess time to tumor progression (TTP) for patients in the control group of the Company's pivotal Phase 3 clinical trial of FavId(R). The DMB assessment, which was conducted in accordance with the clinical protocol under Favrille's Special Protocol Assessment (SPA) with the Food & Drug Administration (FDA), indicated that the control group behavior is consistent with data reported in the published literature. Based in part on the guidance provided by the DMB, Favrille has determined April 2008 to be the appropriate time for data cutoff of the Phase 3 trial. The Company anticipates that the analysis of the data will be completed and made available no later than July 2008.

(Logo: http://www.newscom.com/cgi-bin/prnh/20031013/LAM095LOGO)

The Phase 3 trial is a randomized, double-blind, placebo controlled trial of FavId following Rituxan(R) treatment in patients with follicular B-cell non-Hodgkin's lymphoma (NHL). A total of 349 patients were randomly assigned to receive either FavId plus Leukine(R) (sargramostim, GM-CSF) or placebo plus Leukine following a course of Rituxan treatment. The primary endpoint of this trial is TTP.

"As we previously communicated, the rate of progression in our pivotal Phase 3 trial has slowed during the past 12 months," said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. "We believe this is a positive development, and it has shifted our focus for data cutoff and analysis to trial follow-up time as allowed in the protocol rather than the number of patient progressi
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SOURCE Favrille, Inc.
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