Healthcare Industry News: cutaneous T-cell lymphoma
News Release - July 5, 2006
Favrille Publishes Data From Phase 2 Clinical Trial Demonstrating Biologic Activity of Lead Product Candidate FavId in Indolent Non-Hodgkin's LymphomaResults From Single Agent Trial Published in Current Issue of Journal of Clinical Oncology
SAN DIEGO, July 5 (HSMN NewsFeed) -- Favrille, Inc. (Nasdaq: FVRL ), a biopharmaceutical company developing patient-specific immunotherapies for the treatment of cancer, announced that data from its initial Phase 2 clinical trial evaluating FavIdŽ as a single therapeutic agent in previously treated and relapsed patients with indolent B-cell non-Hodgkin's lymphoma (NHL) have been published in the July 1st issue of the Journal of Clinical Oncology (www.jco.org).
The article, entitled "Phase II Trial of Idiotype Vaccination in Previously Treated Patients With Indolent Non-Hodgkin's Lymphoma Resulting in Durable Clinical Responses," concludes that FavId as a single agent is active and well tolerated in previously treated and relapsed patients with indolent B-cell NHL. Results from this multi-center trial demonstrated a median time to disease progression (TTP) for the 31 evaluable patients in the trial of 13.5 months. The most common adverse events reported were mild to moderate injection site reactions.
"The data from this single agent trial of FavId in previously treated and relapsed patients are very encouraging," said John F. Bender, Pharm.D., Senior Vice President of Clinical Research at Favrille. "This early trial served as proof of concept that FavId demonstrates biologic activity in indolent NHL patients and provided the foundation for subsequent trials of FavId, including our pivotal Phase 3 trial. We look forward to the analysis of the clinical response data from our registration trial later this year."
Phase 3 Clinical Trial Status
Favrille completed enrollment in its randomized, double-blind, placebo-controlled Phase 3 clinical trial of FavId in January 2006. The registration trial is designed to evaluate FavId following Rituxan, the current standard of care, for the treatment of follicular B-cell NHL and includes both treatment-naive and relapsed/refractory patients with stable or responding disease following treatment with Rituxan. The Company anticipates an analysis of the secondary endpoint, response improvement, during the fourth quarter of this year. Analysis of the primary endpoint, TTP, is expected during the second half of 2007. Favrille has a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) for its Phase 3 trial. FavId has also received Fast Track designation 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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