Healthcare Industry News: B-cell NHL
News Release - June 4, 2007
Favrille Reports Status of Phase 2 Clinical Trial of FavId With Maintenance Rituxan for Indolent B-Cell Non-Hodgkin's LymphomaData Reported at American Society of Clinical Oncology Annual Meeting
SAN DIEGO, June 4 (HSMN NewsFeed) -- Favrille, Inc. (Nasdaq: FVRL ), a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, announced data from a Phase 2 clinical trial of FavIdŽ in combination with maintenance RituxanŽ for the treatment of indolent B-cell non-Hodgkin's lymphoma (NHL). The progress of this trial was reported at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Saturday.
"The early data show that concurrent treatment with maintenance Rituxan and FavId is feasible and well tolerated," said John D. Hainsworth, M.D., Principal Investigator and Chief Scientific Officer, Sarah Cannon Research Institute. "This trial is still open to patient enrollment and we will continue to follow these patients in order to better assess the long-term benefit of this approach for the treatment of follicular non-Hodgkin's lymphoma."
The trial is open to treatment-naive patients with indolent NHL and is designed to enroll a total of 56 patients. A poster with additional data from the trial is available on Favrille's website at http://www.favrille.com.
In this ongoing Phase 2 clinical trial, patients receive the same dose and schedule of maintenance Rituxan as was administered in prior trials: four weekly doses of Rituxan every six months for two years. FavId is incorporated into this treatment regimen starting on the third month and is then administered monthly for the first 12 months, every other month for the second 12 months, and every three months thereafter.
"This is the first clinical trial of an Id-KLH active immunotherapy in combination with a maintenance Rituxan regimen," said Richard Ghalie, M.D., Chief Medical Officer of Favrille. "We believe that by incorporating FavId into a schedule of maintenance Rituxan, patients may experience a longer time to tumor progression (TTP) beyond what would be expected from maintenance Rituxan alone, which would offer physicians added flexibility in treating patients with indolent B-cell NHL."
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 Rituxan induction therapy in patients with follicular B-cell NHL in January 2006. The trigger for the analysis of the primary endpoint in the trial, TTP, is based on a specific number of patients reaching disease progression. This is currently projected to occur around the end 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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