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Seattle, WA (August 9, 2002) - Dendreon Corporation (Nasdaq: DNDN) today announced preliminary results from its analysis of what it believes is the first randomized, double blind placebo controlled Phase III study of a cancer vaccine. The product, Provenge(TM) (APC 8015), is Dendreon's investigational vaccine for the treatment of hormone resistant prostate cancer. The investigational drug evaluates a new biologic approach, using the body's own immune system to treat men suffering from late-stage prostate cancer. The study shows that men with hormone resistant prostate cancer who have a Gleason score of 7 or less, which accounts for approximately 75 percent of hormone resistant patients, significantly benefited from Provenge treatment. Dendreon will be hosting a conference call and slide presentation at 6:00 a.m. Pacific Daylight Time today to discuss these results. Call in information is listed below.
Clinical Trial Design and Data
The trial (D9901) involved 127 men with late stage, metastatic, hormone resistant prostate cancer, 82 of whom received Provenge. Patients were randomized to receive three vaccinations of Provenge or placebo over a four-week period. The primary endpoint for the study was the time to objective disease progression. Comparison of the Provenge treated group to the placebo group using the Kaplan-Meier method revealed a clinical benefit in the Provenge treated patients (p-value = 0.085) that approached but did not achieve the pre-specified primary endpoint of the study (p-value = 0.05). The Kaplan-Meier plots of disease progression against time identified a clear difference between the treated versus untreated groups from three months post randomization and continuing throughout the study.
Analysis of the data for pre-specified variables revealed that the single most important predictor of responders to Provenge was a patient's Gleason score, the accepted measure of the aggressiveness of a patient's tumor. In patients with a Gleason score less than or equal to 7 (the most prevalent category in prostate cancer patients), the placebo group had a median time to disease progression of 9.0 weeks compared to 16.0 weeks in the Provenge treated group, with a highly significant p-value of 0.002 and a treatment effect of 78 percent. In addition, those patients receiving Provenge whose disease had not progressed six months after randomization, had a greater than eight-fold advantage in progression-free survival compared to those patients who received placebo (34.7 percent versus 4 percent). In contrast, the benefits of Provenge therapy were not seen in patients with a Gleason score of 8 or higher.
Overall, Provenge was well tolerated by patients, with the most common side effects being chills and fever, which were most often infusion-related. Analysis of the safety data is ongoing and, when complete, will be submitted to the Food and Drug Administration (FDA) as part of Dendreon's registration process.
"We believe this is the most stringent testing of a cancer vaccine that has ever been performed, and we are very encouraged by the results of this study," said Christopher S. Henney, Ph.D., chief executive officer of Dendreon. "In this study, the data demonstrate that the anti-cancer activity of our therapeutic cancer vaccine, Provenge, resulted in a significant delay in the time to disease progression in study patients who have prostate cancer with a Gleason score of 7 or below. This study contained a disproportionately high number of men with a Gleason score of 8 or above, which contributed to the results we saw with our interim analysis in January. After adjustment for these patients, the study yielded a significant therapeutic effect for Provenge."
"We are preparing these data for discussion with the FDA to determine what steps we should take to support an application for product approval with an aim, as soon as is feasible, to make Provenge available to patients for which there is no effective available therapy," said Henney.
"Gleason grade is the most powerful prognostic factor driving virtually all algorithms for pathologic outcome and clinical prognosis," said Paul Schellhammer, M.D., professor and chief of urology at Eastern Virginia Medical School. "The majority of patients newly diagnosed with hormone resistant prostate cancer are graded in the 6 or 7 category. That Provenge provided a statistically significant benefit for this cohort is a very encouraging finding."
"These data are provocative in that they suggest that for those patients with hormone resistant prostate cancer, whose disease is not rapidly progressive, Provenge appears to slow the tempo of the disease. This is particularly important in light of the minimal side effects seen," said Eric J. Small, M.D., professor of medicine and urology at the University of California San Francisco.
Dendreon will work with the clinical trial investigators to prepare and submit data from this trial for presentation at upcoming scientific meetings and for publication in a peer-reviewed medical journal.
"We believe this is a significant advance in the potential treatment of men with hormone resistant prostate cancer and in conjunction with the FDA we will develop a strategy for registration that reflects today's exciting results. In addition, we will be evaluating internally whether to continue alone with Provenge development in the U.S. and Europe, or to seek the commercialization strength of a collaborator," said Mitchell H. Gold, M.D., chief business officer at Dendreon.
About Prostate Cancer
Prostate cancer is the leading cancer diagnosed among men in the United States. More than one million men in the United States have prostate cancer, with 200,000 cases diagnosed and 31,500 deaths in 2001. There is currently no available treatment for hormone resistant prostate cancer.
About Gleason Score
The Gleason Scale 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 hormone refractory patient population approximately 75 percent of the patients have a Gleason score of 7 or less.
About Provenge
Provenge is an investigational therapeutic cancer vaccine designed to jumpstart a person's natural defenses against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP).
About Dendreon
Dendreon Corporation is dedicated to the discovery and development of novel products for the treatment of cancer through its innovative manipulation of the immune system. Dendreon currently has three therapeutic vaccines in clinical trials. Dendreon's product pipeline also includes monoclonal antibodies and a pathway to small molecules. For more information, visit www.dendreon.com.
Conference Call Information:
To access the conference call live via telephone, dial 888-989-7589 (domestic) or 1-630-395-0367 (international) at least ten minutes before the call is scheduled to begin. The passcode for the call is "Dendreon."
An accompanying slide presentation will be available live by linking to http://e-meetings.wcom.com/nc/join/ and supplying the following information:
Net Conference/Meeting Number: P17455841
Conference/meeting passcode: DENDREON (case sensitive)
A replay of the call will be available at 800-945-7570 (domestic) or 402-220-3571(international) as well as online at www.dendreon.com.
Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those 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, including the risk that the FDA may not lift the partial clinical hold on enrollment in our second Phase III trial of Provenge (D9902), 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 for 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 SEC reports, which are available at www.sec.gov
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