Favrille completes enrollment of FavId phase 3 trial in follicular B-cell non-Hodgkin's lymphoma

By E. Janene Geiss

Philadelphia, Jan. 30 - Favrille, Inc. said Monday that it has completed enrollment of its pivotal phase 3 clinical trial of FavId that began in July 2004 to evaluate FavId following Rituxan therapy for the treatment of follicular B-cell non-Hodgkin's lymphoma.

"To complete enrollment in just 18 months is a significant accomplishment and a credit to everyone involved in the trial," John F. Bender, senior vice president of clinical research, said in a company news release.

"The rapid enrollment supports our belief that an all-biologic regimen of Rituxan followed by FavId could, if approved, become the option preferred by patients with indolent B-cell NHL who wish to avoid many of the side effects associated with chemotherapy," Bender added.

The randomized, double-blind, placebo-controlled trial has been conducted at 67 oncology centers across the United States.

The trial has enrolled a much broader patient population than previous immunotherapy trials and included both treatment-naïve and relapsed/refractory patients with stable or responding disease following treatment with Rituxan.

About 80% of the patients enrolled are treatment-naïve with the remainder either relapsed from or refractory to prior therapies, officials said.

Favrille said it anticipates an analysis of the secondary endpoint of this trial, response improvement, during the fourth quarter of this year.

According to the company's Special Protocol Assessment from the Food and Drug Administration, a clinically meaningful response improvement may be the basis for accelerated approval.

Analysis of the primary endpoint of the trial, time to disease progression, is expected during the second half of 2007, officials said.

Favrille said recently that it has been granted fast track designation from the FDA for FavId. That indicates the FDA will expedite the review of a new drug that is intended to treat a serious or life-threatening condition and that demonstrates the potential to address an unmet medical need.

Favrille is a San Diego biopharmaceutical company focused on the research, development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system.

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