Dendreon Corporation Announces Provenge Prostate Cancer Vaccine Significantly Delays Onset of Disease-Related Pain.Business Editors & Health/Medical Writers BIOWIRE2K Society of Urologic Oncology Meeting SEATTLE--(BUSINESS WIRE)--Dec. 11, 2002 Updated Clinical Data to be Presented at Society of Urologic Oncology Meeting Dendreon Corporation (Nasdaq:DNDN) today announced additional results from its first placebo controlled Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial (D9901) of Provenge(TM) indicating that, in addition to delaying the time to progression of disease, the investigational cancer vaccine The term cancer vaccine is often used to describe a process whereby a person's immune system is coaxed into recognizing and destroying malignant cells without harming normal cells. delayed the onset of disease-related pain in patients with hormone resistant (androgen androgen (ăn`drəjən): see testosterone. androgen Any of a group of hormones that mainly influence the development of the male reproductive system. independent) prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. with a Gleason score Gleason score Oncology A value derived from the Gleason grading system which is the sum of the 2 most predominant histologic patterns seen in prostate CA of 7 or less. The results will be presented Friday, Dec. 13, at the Society of Urologic Oncology meeting in Bethesda, Maryland Bethesda is an urbanized, but unincorporated, area in southern Montgomery County, Maryland, just Northwest of Washington, D.C. It takes its name from a church located there, the Bethesda Presbyterian Church, built in 1820 and rebuilt in 1850, which in turn took its name from , by Dr. Paul Schellhammer, professor and chief of urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. at Eastern Virginia Medical School Eastern Virginia Medical School, in Norfolk, Virginia is a public medical school. . Delay in the onset of cancer-related pain cancer-related pain, n pain with acute, chronic, and psychological aspects experienced by cancer patients. Associated with the disease process and treatment. was the secondary endpoint of study D9901, which enrolled only patients who did not have cancer-related pain at the time of entry. In patients with a Gleason score of 7 or less, those receiving treatment with Provenge remained pain free significantly longer than those receiving placebo (p=.019). For patients with a Gleason score of 7 or less treated with Provenge, the probability of remaining free of cancer-related pain while on the study was over two-and-one-half-fold higher than for patients treated with placebo, with a Hazard Ratio of 2.6 and a 95 percent Confidence Interval confidence interval, n a statistical device used to determine the range within which an acceptable datum would fall. Confidence intervals are usually expressed in percentages, typically 95% or 99%. (1.1 - 6.0). As with the previously reported time to progression data in study D9901, no apparent benefit on the pain endpoint was observed among patients with Gleason scores of 8 or higher. "These new findings related to the study's secondary endpoint, a delay in the onset of disease-related pain, indicate that in addition to delaying the time to disease progression of advanced prostate cancers with Gleason Scores of 7 or lower, Provenge may also prove beneficial in delaying the time until patients develop disease-related pain," said Schellhammer. "The corroboration of these two endpoints is very promising." Schellhammer will present results from the trial in a "Late Breaking Developments" presentation at the conference. Dendreon recently announced that, following discussions with the U.S. Food and Drug Administration, the company will amend the protocol for its current Phase III trial (D9902) of Provenge to enroll only advanced hormone resistant prostate cancer patients with a Gleason score of 7 or less. Previously announced results from the Provenge trial D9901 demonstrated significant benefit from Provenge treatment for men with hormone resistant prostate cancer who have a Gleason score of 7 or less. In that group of 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, the patients receiving Provenge whose disease had not progressed six months after randomization randomization (ranˈ·d  ·m had a greater than eight-fold advantage in progression-free survival
compared to the patients who received placebo (34.7 percent of Provenge
patients versus 4 percent of placebo patients).
Overall, Provenge was well tolerated by patients, with the most common side effects Side effects Effects of a proposed project on other parts of the firm. being chills and fever Noun 1. chills and fever - successive stages of chills and fever that is a symptom of malaria ague malaria - an infective disease caused by sporozoan parasites that are transmitted through the bite of an infected Anopheles mosquito; marked by paroxysms of , which were most often infusion-related. Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. Dendreon currently has a number of therapeutic vaccines in clinical trials. Dendreon's product pipeline also includes monoclonal antibodies and a pathway to small molecules. Dendreon has established important alliances with industry leaders Genentech, Inc., Johnson & Johnson Pharmaceutical Research & Development and Kirin Brewery Co., Ltd. For more information, visit 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 consideration of data by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and FDA approval of applications for a biologics license 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 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, the risk that the results of a clinical trial for Provenge 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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