Dendreon Presents Integrated Analysis of Clinical Data from Neuvenge Trials at Chemotherapy Foundation Symposium
SEATTLE, November 06, 2008 /PRNewswire-FirstCall/ -- Dendreon Corporation today will present a summary of Phase 1 clinical data of NEUVENGE(TM) (lapuleucel-T), an investigational active cellular immunotherapy, at the Chemotherapy Foundation Symposium in New York City. The presentation, which integrates the data from two clinical trials, highlights the safety profile, immune response and clinical activity of NEUVENGE in patients with HER2/neu-positive cancer who have failed standard therapy.
"We are encouraged by the significant immune responses generated to NEUVENGE in these trials, which included patients with advanced breast, ovarian and colon cancer," said John W. Park, M.D., associate clinical professor of medicine and neurosurgery at the . "The therapy was well tolerated and demonstrated evidence of clinical activity, with several patients experiencing prolonged periods of disease stabilization following treatment. These findings warrant further study of this promising immunotherapy."
The two Phase 1 studies (D2000-1 and D2000-2) were designed to evaluate the safety and immunologic activity of NEUVENGE in patients with metastatic HER2/neu-expressing cancer who had evidence of progressive disease following standard therapies. Patients underwent three infusions of NEUVENGE over an approximately one month period. Patients who achieved a partial response, or had stable disease lasting through Week 48, were eligible for re-treatment with a booster, using the same protocol and dose as the initial treatment.
A total of 37 patients were treated. Results from the integrated analysis showed that treatment with NEUVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fatigue, fever and chills. The median T cell proliferative stimulation index in response to the immunizing antigen increased from 1.3 at baseline to 19.7 at Week 4 (p = 0.0002), 19.4 at Week 8 (p < 0.0001) and 20.7 at Week 16 (p = 0.02). Immune monitoring performed in three of four patients who underwent repeat treatment suggested an increase in immune response following the booster treatments. Five patients had prolonged disease stabilization ranging from 48 to 94 weeks, without the addition of other cancer therapy other than the continuation of bisphosphonates. In addition, one patient experienced a partial response lasting approximately six months.
"We were pleased to see consistent results across both NEUVENGE trials, particularly as they further substantiate the tolerability of this therapeutic approach," stated Mark Frohlich, M.D., senior vice president, clinical affairs and chief medical officer. "These data provide further evidence of the promise of our active cellular immunotherapy platform which also includes PROVENGE(R) (sipuleucel-T), our lead product candidate currently in late-stage development for prostate cancer. We expect to receive the final data analysis from our ongoing Phase 3 PROVENGE trial in mid-2009 and look forward to discussing further clinical development plans for NEUVENGE and our immunotherapy pipeline after that time."
NEUVENGE (lapuleucel-T) is an investigational product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. ACIs hold promise because they may provide patients with a meaningful clinical benefit with low toxicities. NEUVENGE is designed to stimulate cellular immune responses against HER2/neu. HER2/neu is over-expressed in a variety of solid tumors, including breast, colorectal, bladder and ovarian cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com.
Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, the efficacy of PROVENGE or sipuleucel-T, the company's lead product candidate to treat men suffering from prostate cancer, the efficacy of NEUVENGE or lapuleucel-T, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE or NEUVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the results of a clinical trial for PROVENGE, NEUVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE or NEUVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and
CONTACT: Investors, Jennifer Williams, Investor Relations of DendreonCorporation, +1-206-829-1500; or Media, Katherine Stueland of WeissCommPartners, +1-312-208-0320, for Dendreon Corporation
Web site: http://www.dendreon.com/
Ticker Symbol: (NASDAQ-NMS:DNDN)
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Posted: November 2008