We are a biopharmaceutical company focused on the development and commercialization of patient-specific immunotherapies for the treatment of cancer and other diseases of the immune system. We own a proprietary technology that enables us to efficiently develop and manufacture active immunotherapy products designed to stimulate a patient's own immune system to mount a specific and sustained response to disease.
Our lead product candidate, Specifid™ (formerly FavId®), is an active immunotherapy for the treatment of B-cell non-Hodgkin's lymphoma. We completed enrollment in a pivotal Phase 3 clinical trial of Specifid in January 2006. The randomized, double-blind, placebo-controlled registration trial is designed to evaluate Specifid following Rituxan®, the current standard of care, for the treatment of follicular B-cell non-Hodgkin's lymphoma. We have a Special Protocol Assessment from the U.S. Food & Drug Administration (FDA) for our Phase 3 trial. Specifid has also received Fast Track designation from the FDA. Analysis of the primary endpoint, time to disease progression, is expected no later than July 2008.
In addition to our pivotal Phase 3 trial, we have additional Phase 2 and Phase 2/3 clinical trials of Specifid ongoing in other B-cell non-Hodgkin's lymphoma indications. We are also developing additional applications based upon our immunotherapy expertise and proprietary technology, including a second product candidate, FAV-201, for the treatment of cutaneous T-cell lymphoma.