Seattle, WA (January 12, 2004) - Dendreon Corporation (NASDAQ:DNDN) today announced updated survival data from patients with advanced prostate cancer with Gleason Scores of seven and less who participated in its completed and previously reported Phase 3 trial (D9901) of Provenge, the Company's investigational immunotherapy for the treatment of prostate cancer.
Patients with Gleason Scores of seven and less receiving Provenge had a significant survival advantage, having on average an 89 percent overall increase in their survival time as compared to placebo (log rank p= 0.047, hazard ratio = 1.89). This benefit is reflected by a prolongation in the median survival time in patients receiving Provenge by 8.4 months (30.7 months versus 22.3 months). At 30 months from randomization, the survival rate for Provenge-treated patients is 3.7 times higher than for patients receiving placebo (53 percent versus 14 percent, p= 0.001).
Consistent with previous reports, a majority of those patients in D9901 who are still alive have received treatment with Provenge and will continue to be followed according to the study protocol. The Company expects to present this as well as other updated data at major scientific meetings throughout the year.
Prostate cancer is the most common non-skin cancer in the United States. More than one million men in the United States have prostate cancer, with an estimated 220,000 cases diagnosed and 28,900 deaths in 2003.
"This is the longest survival benefit ever reported in a Phase 3 study in late stage prostate cancer," said Dr. John M. Corman Director of the Virginia Mason Comprehensive Prostate Cancer Clinic and Assistant Clinical Professor of Urology at the University of Washington in Seattle. "With the combination of this exciting new survival data and favorable side effect profile, Provenge has the potential to change the way we treat prostate cancer in the future."
These updated survival data are consistent with other previously reported data from the D9901 trial that showed significant clinical benefit from Provenge treatment for men with a Gleason Score of seven and less. For these men, the average time to disease progression is more than two-fold longer than that for patients treated with placebo (p = 0.001) and the average time to experiencing cancer-related pain is more than 2.5 times longer than that for patients treated with placebo (p = 0.016). Treatment was well tolerated, with mild infusion-related fevers and chills the most common adverse events. As previously reported, no benefit has been seen in men with Gleason Scores of eight and higher.
Last year, Dendreon also released data confirming Provenge's mechanism of action based on T-cell mediated immune response. These data showed that among men treated with Provenge, those with a Gleason Score of seven and less demonstrated a T-cell mediated immune response 7-fold greater than men with a Gleason Score of eight or more (p=0.0065).
"Based on the strength of this survival data, which is consistent with all of the data gathered to date on our other endpoints in the trial for patients with Gleason Scores of seven and less, we are more enthusiastic than ever regarding the pivotal role that Provenge may play in providing a new and well tolerated targeted therapy for prostate cancer patients," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "The results from this study represent an important milestone in the fight against prostate cancer and indicate that Provenge may provide for a well-tolerated treatment option that offers patients a potential survival advantage."
The ongoing, pivotal D9902B Phase 3 trial of Provenge is based on the knowledge gained from the results of D9901. The study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Provenge also has Fast Track designation. The pivotal double blind, placebo-controlled D9902B trial is now underway at leading cancer centers around the country. To be eligible for the study, patients must have metastatic prostate cancer that has progressed following hormone therapy and have a Gleason Score of seven and less. Patients must also be free of cancer-related pain. To learn more about the trial, go to www.dendreon.com or call 1-866-4-PROSTATE (1-866-477-6782).
Dendreon will host a conference call today, Monday, January 12, 2004, at 7:00 a.m. Pacific Time (10:00 a.m. Eastern Time). To access the call, please dial 888-323-9686 (domestic) or 210-234-0006 (international). The passcode for the call is "Dendreon." A replay of the call will be available by phone at 800-925-4850 (domestic) or 402-220-4323 (international).
Provenge is designed to stimulate a man's immune system against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette™ technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP).
About Gleason Score
The Gleason Score is the most commonly used prostate cancer scoring system and is considered one of the most important prognostic indicators for prostate cancer. The score is based on tissue findings throughout the prostate that correlate with the aggressiveness of a tumor. High Gleason Scores are indicative of aggressive cancers and are not associated with a favorable prognosis. In the androgen independent patient population approximately 75 percent of the patients have a Gleason Score of seven and less.
Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody, small molecule and prodrug product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com.
Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of Provenge to treat men suffering from prostate cancer, 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 a difference include risks related to Dendreon's limited operating history, risks associated with completing our clinical trials, the risk that preliminary analyses of data may not be confirmed by final data, the risk that the safety and/or efficacy results of a clinical trial for Provenge will not support an application for a biologics license, the risk that the FDA will not be satisfied with the data we provide for Provenge or approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for Provenge 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, dependence on the efforts of third parties, including collaborators, 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 Exchange Commission (SEC), which are available at www.sec.gov.