Favrille, Inc., a biopharmaceutical company developing patient-specific immunotherapies for the treatment of cancer, has been granted Fast Track designation by the US FDA for FavId, its lead product candidate for the treatment of B-cell follicular non-Hodgkin's lymphoma (NHL). FavId is currently in a pivotal Phase 3 clinical trial following Rituxan therapy in patients with follicular B-cell NHL.

"This decision by the FDA has the potential to save us valuable time in the regulatory approval process, and also serves as an important acknowledgement of the potential for FavId in the treatment of B-cell follicular NHL," said John P. Longenecker, president and chief executive officer of Favrille. "We look forward to reporting additional progress in the development of FavId this year, culminating with our first look at clinical activity in our Phase 3 registration trial in the fourth quarter using the secondary endpoint of Response Improvement," he added.

Favrille recently reported positive long-term follow-up data from its Phase 2 clinical trial of FavId at the American Society of Hematology Annual Meeting in Atlanta. The data suggests that administration of FavId following Rituxan in patients with follicular B-cell NHL appears to improve the response rate over Rituxan alone and extend time to disease progression (TTP) compared to historical data. The data also compare favourably with previous immunotherapy studies.

Favrille is nearing completion of patient enrolment in its randomized, double-blind, placebo-controlled Phase 3 registration trial. The Company initiated the trial in July 2004 with a target of 342 eligible patients. Favrille anticipates an analysis of a secondary endpoint of the trial, Response Improvement, during the fourth quarter of this year. The final analysis of the primary endpoint of the trial, TTP, is expected during the second half of 2007.