Our lead product candidate, FavId, is an active immunotherapy that is based upon unique genetic information extracted from a patient's tumor. It is designed to stimulate a patient's immune system to mount a specific and sustained response to disease. FavId is currently being developed for use following treatment with existing standards of care to extend time to disease progression in patients with B-cell non-Hodgkin's lymphoma. We currently retain exclusive worldwide commercialization rights to FavId.
We completed enrollment in a randomized, double-blind, placebo-controlled Phase 3 clinical trial of FavId in January 2006. 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-naive and relapsed/refractory patients with stable or responding disease following treatment with Rituxan. The trial is being conducted under a Special Protocol Assessment from the FDA. FavId has also received Fast Track designation from the FDA. Analysis of the primary endpoint, time to disease progression, is expected during the first half of 2008.
In addition, we have conducted several multi-center, open-label Phase 2 clinical trials of FavId involving more than 130 indolent B-cell non-Hodgkin's lymphoma patients. We presented long-term follow-up data from our Phase 2 clinical trial of FavId following Rituxan at the American Society of Hematology Annual Meeting in Atlanta in December 2005. These data suggest that the administration of FavId following Rituxan may improve response over Rituxan alone and extend time to disease progression compared to historical data of Rituxan alone in patients with follicular B-cell non-Hodgkin's lymphoma.