Favrille FVRL
Tough time for an IPO.
We are a biopharmaceutical company focused on the research, development and commercialization of targeted immunotherapies for the treatment of cancer and diseases of the immune system. We have developed a proprietary technology that enables us to manufacture active immunotherapy product candidates that are designed to stimulate a patient's immune system to mount a specific and sustained response to disease.
Our lead product candidate, FavId, is an active immunotherapy for the treatment of indolent B-cell non-Hodgkin's lymphoma, or NHL, that is based upon unique genetic information extracted from a patient's tumor. FavId is being developed to be used following treatment with existing standards of care to induce more durable remissions for patients with indolent B-cell NHL. In May 2004, we received a Special Protocol Assessment, or SPA, from the FDA for our randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating FavId, which we initiated in July 2004. To date, FavId has been evaluated in two multi-center, open-label Phase 2 clinical trials involving over 120 patients. Preliminary results from these trials suggest that FavId can induce remissions when used alone and may increase time to disease progression, or TTP, following treatment with the approved product Rituxan. Four additional physician-sponsored Phase 2 clinical trials of FavId in other types of B-cell NHL are either ongoing or expected to begin during 2004, and we expect to initiate another Phase 2 clinical trial of FavId in the first half of 2005. We currently retain exclusive worldwide commercialization rights to FavId.
Researchers have been conducting clinical trials of active immunotherapies in patients with B-cell NHL for more than a decade. The results of clinical trials at the Stanford University Medical Center and the National Cancer Institute, or NCI, suggest that active immunotherapies similar to FavId, when used following chemotherapy, may induce long-term remission and improve survival time among indolent B- cell NHL patients. Despite the promising results of these trials, we believe manufacturing limitations have hindered commercialization of these immunotherapies. We have developed a proprietary technology that we believe enables us to overcome historical limitations to the manufacturing and commercialization of active immunotherapies for B-cell NHL. We believe that our technology will enable us to manufacture FavId in a timely and cost-effective manner and allow us to offer a treatment option not currently available to physicians and patients.
We believe our active immunotherapy expertise and proprietary manufacturing technology will enable us to develop additional product candidates for other oncology indications, such as T-cell lymphoma, and for autoimmune diseases. We are currently developing a second product candidate, FAV-201, for the treatment of T-cell lymphoma and intend to initiate a Phase 1/2 clinical trial in the fourth quarter of 2004. We also intend to initiate preclinical studies to identify additional product candidates for the treatment of autoimmune diseases, with an initial focus on multiple sclerosis, during the second half of 2004. |
