SAN DIEGO, Jan. 30 /PRNewswire-FirstCall/ -- Favrille, Inc. , a biopharmaceutical company developing patient-specific immunotherapies for the treatment of cancer, announced today that it has completed enrollment in the Company’s pivotal Phase 3 clinical trial of FavId(R). Initiated in July 2004, the registration trial is designed to evaluate FavId following Rituxan(R) therapy for the treatment of follicular B-cell non-Hodgkin’s lymphoma (NHL).
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“To complete enrollment in just 18 months is a significant accomplishment and a credit to everyone involved in the trial,” said John F. Bender, Pharm.D., Senior Vice-President of Clinical Research. “The rapid enrollment supports our belief that an all-biologic regimen of Rituxan followed by FavId could, if approved, become the option preferred by patients with indolent B-cell NHL who wish to avoid many of the side effects associated with chemotherapy.”
The randomized, double-blind, placebo-controlled trial has been conducted at 67 oncology centers across the U.S. The trial has enrolled a much broader patient population than previous immunotherapy trials, and included both treatment-naive and relapsed/refractory patients with stable or responding disease following treatment with Rituxan. Approximately 80 percent of the patients enrolled are treatment-naive with the remainder either relapsed from or refractory to prior therapies.
Favrille anticipates an analysis of the secondary endpoint of this Phase 3 trial, response improvement, during the fourth quarter of this year. According to Favrille’s Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA), a clinically meaningful response improvement may be the basis for accelerated approval.
Analysis of the primary endpoint of the trial, time to disease progression, is expected during the second half of 2007. In addition, Favrille recently announced that it has been granted Fast Track designation from the FDA for FavId. A Fast Track designation indicates that the FDA will expedite the review of a new drug that is intended to treat a serious or life-threatening condition and that demonstrates the potential to address an unmet medical need.
About Favrille, Inc.
Favrille, Inc. is a biopharmaceutical company focused on the research, 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 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 potential delays in patient enrollment; 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; 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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CONTACT: Tamara A. Seymour, CFO and Vice President, Finance &Administration, +1-858-526-8035, tseymour@favrille.com, or Pete De Spain,Associate Director, Investor Relations & Corporate Communications,+1-858-526-2426, pdespain@favrille.com, both of Favrille, Inc.
Web site: http://www.favrille.com//
