Healthcare Industry News: B-cell NHL
News Release - February 12, 2007
Favrille Announces Long-Term Follow-Up Data From Phase 2 Clinical Trial of FavId Following Autologous Stem Cell Transplantation for B-Cell Non-Hodgkin's LymphomaData Reported at Blood and Marrow Transplantation Tandem Meetings
SAN DIEGO, Feb. 12 (HSMN NewsFeed) -- Favrille, Inc. (Nasdaq: FVRL ), a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, announced long-term follow-up data from a physician-sponsored Phase 2 clinical trial of FavIdŽ following high dose therapy and autologous stem cell transplantation in patients with non-Hodgkin's lymphoma (NHL). The data were reported at the annual meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) in Keystone, Colo., on Friday.
A total of 15 patients were treated in the trial, of which nine remain in complete remission up to 61 months post-transplant. The median number of prior regimens for all patients was three, ranging from one to 10. The data showed that the majority of patients in the trial developed a rapid and tumor-specific immune response, often measured following a single dose of FavId. A poster with additional data from the trial is available on Favrille's website at www.favrille.com.
"The data from this early stage trial suggests that FavId following high dose therapy and autologous stem cell transplantation is feasible, well tolerated and may be associated with durable remissions, even in heavily pretreated patients," said Peter Holman, M.D., principal investigator and Associate Clinical Professor of Medicine at the Moores University of California, San Diego (UCSD) Cancer Center, Blood and Marrow Transplantation Division.
Patient enrollment in this physician-sponsored trial began in November 2000. The trial was designed to evaluate the ability of FavId to induce humoral and cell-mediated immune responses, and to induce or maintain complete remission following autologous stem cell transplantation. In addition, the trial is evaluating the correlation of specific T-cell populations with immune responsiveness to FavId. Autologous stem cell transplantation involves removing vital blood cells from a patient before administering large doses of chemotherapy. After chemotherapy, the blood cells are returned to the patient to speed recovery from the chemotherapy treatment. At three months following transplantation, patients in the trial received the first of five monthly injections of FavId and were then assessed at fixed intervals.
FavId is a patient-specific, Id/KLH active immunotherapy for the treatment of B-cell NHL. Favrille completed enrollment in its pivotal Phase 3 clinical trial of FavId following RituxanŽ induction therapy in patients with follicular B-cell NHL in January 2006, and expects to trigger the analysis of the primary endpoint, time to disease progression, during the fourth quarter of 2007. The Company has a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) for its Phase 3 trial, and has also received Fast Track designation for FavId from the FDA.
About Favrille, Inc.
Favrille, Inc. is a biopharmaceutical company focused on the development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system. The Company's lead product candidate, FavId, is based upon unique genetic information extracted from a patient's tumor. FavId 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, including a second product candidate, FAV-201, for the treatment of cutaneous T-cell lymphoma.
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to Favrille's product candidates, proprietary technologies and research programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Favrille's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to progress and timing of clinical trials for FavId, including difficulties or delays in development, testing, manufacturing and marketing FavId or Favrille's other product candidates; Favrille's ability to obtain marketing approval for FavId or Favrille's other product candidates and the timing of any such approvals; Favrille's ability to manufacture sufficient quantities of FavId for use in clinical trials and, if FavId receives marketing approval, for commercialization; risks associated with achieving projected operating metrics and financial performance or the anticipated number of patients using FavId; potential delays in patient enrollment; Favrille's ability to obtain additional financing to support its operations; and additional risks discussed in Favrille's filings with the Securities and Exchange Commission. In addition, conclusions regarding the safety and efficacy of Favrille's product candidates cannot be made until the results of future clinical trials of longer duration in more patients are known. All forward-looking statements are qualified in their entirety by this cautionary statement. Favrille is providing this information as of the date of this release and, except as required by law, does not undertake any obligation to update any forward- looking statements contained in this release as a result of new information, future events or otherwise.
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