Favrille says data from phase 2 trial demonstrates biologic activity of FavId in lymphoma

By E. Janene Geiss

Philadelphia, July 5 - Favrille, Inc. said Wednesday that data from its initial phase 2 clinical trial evaluating FavId as a single therapeutic agent in previously treated and relapsed patients with indolent B-cell non-Hodgkin's lymphoma showed that FavId as a single agent is active and well-tolerated.

Results from this multi-center trial demonstrated a median time to disease progression for the 31 evaluable patients in the trial of 13.5 months, according to a company news release.

The most common adverse events reported were mild to moderate injection site reactions, officials said.

Results from the trial were published in the July 1 issue of the Journal of Clinical Oncology.

"The data from this single agent trial of FavId in previously treated and relapsed patients are very encouraging," John F. Bender, senior vice president of clinical research, said in the release.

Results of this early trial served as proof of concept that FavId demonstrates biologic activity in indolent non-Hodgkin's lymphoma patients and provided the foundation for subsequent trials of FavId, including the company's pivotal phase 3 trial, officials said.

Favrille said it completed enrollment in its randomized, double-blind, placebo-controlled phase 3 trial of FavId in January.

The registration trial is designed to evaluate FavId following Rituxan, the current standard of care, for the treatment of follicular B-cell non-Hodgkin's lymphoma and includes both treatment-naïve and relapsed/refractory patients with stable or responding disease following treatment with Rituxan.

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

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

Favrille said it has a Special Protocol Assessment from the Food and Drug Administration for its phase 3 trial.

FavId also has fast-track designation from the FDA, officials said.

Favrille is a San Diego biopharmaceutical company focused on treatments for cancer and other immune system diseases.

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