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news.Data from an initial phase II clinical trial of Favrille's investigational drug FavId has shown it to be active and well tolerated as a single therapeutic agent in previously treated and relapsed patients with indolent B-cell non-Hodgkin's lymphoma.
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The data, published in the Journal of Clinical Oncology, demonstrated a median time to disease progression (TTP) for the 31 evaluable patients in the trial of 13.5 months. The most common adverse events reported were mild to moderate injection site reactions.
“The data from this single agent trial of FavId in previously treated and relapsed patients are very encouraging,” said Dr John Bender, senior vice president of clinical research at Favrille. “This early trial served as proof of concept that FavId demonstrates biologic activity in indolent NHL patients and provided the foundation for subsequent trials of FavId, including our pivotal phase III trial.”
Biopharmaceutical company Favrille completed enrollment in its randomized, double-blind, placebo-controlled phase III clinical trial of FavId in January 2006. The company anticipates an analysis of the secondary endpoint, response improvement, during the fourth quarter of this year. Analysis of the primary endpoint, TTP, is expected during the second half of 2007.
Favrille has a special protocol assessment from the FDA for its phase III trial of FavId which has also received fast track designation.