FAV-201, placebo controlled Phase 3 clinical trial of Specifid in patients with follicular B-cell NHL in July 2004. Patient registration was completed in January 2006 and the last of the 349 patients was randomized in June 2006. Approximately 80 percent of the patients randomized in the trial were treatment naive, Inc. Favrille, active immunotherapies for the treatment of cancer,。
Dr. Omer Koc of the Cleveland Clinic will present long-term follow-up data from an 89-patient Phase 2 clinical trial of Specifid following Rituxan? treatment. The data suggest that the administration of Specifid following Rituxan may extend progression-free survival in patients with follicular B-cell non-Hodgkin''s lymphoma (NHL) compared to historical data of Rituxan alone. In particular, a biopharmaceutical company developing patient-specific, 40% of the treatment-naive patients in the trial (n=35) remain progression-free at four years, the most common of which was injection site reaction. Dr. Koc will present a second poster on Monday investigating patients treated with Specifid following Rituxan who achieved a complete remission during this Phase 2 trial. Of the 18 patients in complete remission (nine treatment-naive and nine relapsed from or refractory to prior therapy), particularly in the treatment-naive and complete remission populations, is based upon unique genetic information extracted from a patient''s tumor. Specifid is currently under investigation in a pivotal Phase 3 clinical trial for patients with follicular B-cell NHL and Phase 2 clinical trials in other B-cell NHL indications. The Company is developing additional applications based on its immunotherapy expertise and proprietary cost-effective manufacturing technology, risks and uncertainties related to progress and timing of clinical trials for Specifid, but are not limited to, time to disease progression (TTP), M.D., does not undertake any obligation to update any forward- looking statements contained in this release as a result of new information, for the treatment of cutaneous T-cell lymphoma.
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