Healthcare Industry News: B-cell NHL
News Release - December 6, 2007
Favrille to Report New Data on FavId (Now Specifid) at American Society of Hematology Annual MeetingNew Product Name Also Unveiled in Ongoing Preparation for Commercial Launch
SAN DIEGO, Dec. 6 (HSMN NewsFeed) -- Favrille, Inc. (Nasdaq: FVRL ), a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, announced that new data, including four-year follow-up data from the Company's Phase 2 clinical trial of Specifid(TM) (formerly FavIdŽ), will be reported in four separate poster presentations at the American Society of Hematology (ASH) Annual Meeting, which begins Saturday in Atlanta.
On Sunday, 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 RituxanŽ 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, 40% of the treatment-naive patients in the trial (n=35) remain progression-free at four years, compared to the published literature, which shows that approximately 20% of patients treated with Rituxan alone were progression-free at three years. Most adverse events reported in the trial were of low grade, 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), only six have progressed to date and one withdrew from the trial while in complete remission. The 11 remaining patients continue to be disease-free four to five years from the start of Rituxan. In addition, 16 of the patients who achieved a complete remission did so during the Specifid phase of the trial and converted as late as 33 months from the start of Rituxan.
"We continue to be encouraged by the long-term follow-up data from this trial, particularly in the treatment-naive and complete remission populations," said Richard Ghalie, M.D., Favrille's Chief Medical Officer. "These data reaffirm our confidence in our pivotal Phase 3 trial of Specifid following Rituxan, which has a high proportion of each of the populations who appear to benefit the most. We look forward to the primary endpoint data in our Phase 3 trial next summer and ultimately to advancing this important therapy to the marketplace so that it may be made broadly available to patients in need."
Additional Specifid-related posters at the ASH Annual Meeting will include:
-- A presentation by Dr. John Timmerman from the University of California, Los Angeles on Sunday will present data comparing Id-KLH active immunotherapy generated in insect cells (Specifid) to Id-KLH produced in a traditional mammalian cell manufacturing process. The analysis concludes that Id-KLH produced via insect cells results in a more immunogenic response in a number of in vitro and in vivo assays, and may lead to improved activity of the final Id-KLH active immunotherapy product.
-- A presentation by Dr. David Maloney of the Fred Hutchinson Cancer Research Center on Monday analyzing the role of Fc receptor polymorphisms on the outcome of treatment with Rituxan followed by Specifid. The data suggest that long-term progression-free survival following a treatment regimen of Rituxan plus Specifid does not correlate with inheritance of particular Fc receptor polymorphisms nor with the production of anti-idiotypic antibody and therefore may rely more on a cell-mediated immune response.
A copy of each poster presentation will be available on Favrille's website at http://www.favrille.com beginning on Monday.
About the Phase 3 Clinical Trial of Specifid
Favrille initiated a pivotal, double-blind, 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, with the remainder either relapsed from or refractory to prior therapy. The Company anticipates analysis of the primary endpoint for the trial, time to disease progression (TTP), no later than July 2008. The pivotal Phase 3 trial is being conducted under a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA). Favrille has also received Fast Track designation from the FDA for Specifid.
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, Specifid (formerly FavId), 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, 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 Specifid, including difficulties or delays in development, testing, manufacturing and marketing Specifid or Favrille's other product candidates; delays in the availability of data from Favrille's Phase 3 clinical trial; Favrille's ability to obtain marketing approval for Specifid or Favrille's other product candidates and the timing of any such approvals, including whether it will receive expedited review as a result of the Fast Track designation; Favrille's ability to demonstrate that its idiotype protein produced from insect cell lines may stimulate a more effective immune response compared to idiotype protein derived from mammalian cells; Favrille's ability to manufacture sufficient quantities of Specifid for use in clinical trials and, if Specifid receives marketing approval, for commercialization; risks associated with achieving projected operating metrics and financial performance or the anticipated number of patients using Specifid; 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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