Dendreon Corporation to Participate in Needham & Company Biotechnology Conference.Business Editors/Health/Medical Writers BIOWIRE2K Needham & Company Biotechnology Conference SEATTLE--(BUSINESS WIRE)--June 3, 2003 CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Mitchell Gold to Highlight Data Presented at Recent American Society of Clinical Oncology Meeting Dendreon Corporation (Nasdaq:DNDN) today announced that Chief Executive Officer Mitchell H. Gold, M.D., will present at the Needham & Company Biotechnology Conference taking place June 5-6, 2003 at the New York Palace
New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. . Gold is scheduled to present at 3 p.m. Eastern Time on Thursday, June 5. Members of the public can listen to a live webcast of the presentation by visiting Dendreon's website www.dendreon.com under "News & Events." Gold will provide a corporate update including highlights of data recently presented at the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. 2003 Annual Meeting in Chicago, Ill. These include: -- Data from the Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. , D9901, of Provenge(R), Dendreon's investigational therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. and lead product candidate, confirming that the product's underlying mechanism of action, a T-cell immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. , is consistent with the positive clinical response seen in patients with advanced, metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. 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. . The results show that Provenge treatment induced a highly significant T-cell mediated immune response compared to placebo (p=0.0003), with Provenge treated patients demonstrating an eight-fold increase in T-cell proliferation compared to placebo. In addition, among men treated with Provenge, those whose tumors were graded 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 developed a median change in T-cell mediated immune response seven-fold greater than the T-cell mediated immune response seen in Provenge-treated men whose tumors were graded a Gleason score of 8 and higher (p=0.0065). These results are consistent with, and support the biologic rationale of, previously announced data from the D9901 Phase 3 trial that demonstrated a significant delay in both time to disease progression and time to 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. for men with Gleason 7 or less tumors following treatment with Provenge. -- Preliminary results from a Phase 2 trial, P-16, indicating that a combination therapy of Provenge(R) and Bevacizumab (Avastin(TM)) has demonstrated evidence of decreasing PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. doubling time doubling time Oncology A parameter used to determine tumor aggressiveness, which serves to prognosticate, measure therapeutic success, and quantify tumor kinetics and growth rate. Cf Gompertzian growth curve. in men with androgen dependent prostate cancer. Of 9 patients evaluable for PSA doubling time (PSADT), median PSADT increased nearly three fold, from 8.2 months prior to study entry to 21.4 months after treatment with Provenge and Bevacizumab. PSA doubling time is a measure of the rate of change of PSA over time. Changes in PSADT can only be calculated for patients who have a rising PSA after therapy. Three patients also had PSA decreases from baseline of 12%, 33% and 64% respectively. -- Results from an ongoing Phase 1 trial of APC (1) (American Power Conversion Corporation, West Kingston, RI, www.apcc.com) The leading manufacturer of UPS systems and surge suppressors, founded in 1981 by Rodger Dowdell, Neil Rasmussen and Emanual Landsman, three electronic power engineers who had worked at MIT. 8024, Dendreon's investigational therapeutic vaccine for breast, colon and ovarian cancer, which indicate the product is well-tolerated, stimulates T-cell immunity and is continuing to show ongoing clinical benefit in patients with advanced, metastatic Her-2 positive breast cancer. Four of 16 patients evaluated for clinical response demonstrated clinical benefit defined as a partial response or prolonged stable disease. This included one patient who experienced a partial response as measured by a 50 percent reduction in tumor size that lasted 25 weeks, and three patients who have experienced ongoing stable disease. Of the three patients with stable disease, one has had stable disease for more than 48 weeks (11 months) and two patients have had stable disease for more than one year following treatment with APC8024. Overall, treatment with APC8024 was shown to be well tolerated, with no significant side effects reported and no evidence of any cardiotoxicity. Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its therapeutic vaccines in clinical and pre-clinical development for a variety of cancers, Dendreon's product pipeline includes monoclonal antibody and small molecule product candidates. Dendreon has established important research and development alliances with industry leaders Genentech, Inc. and Kirin Brewery Co., Ltd. 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 that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those 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 the uncertainty of Dendreon's future access to capital, Dendreon's limited operating history, risks associated with completing Dendreon's clinical trials, the risk that the safety and/or efficacy results of a clinical trial will not support an application for a biologics license, the risk that 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. will not approve a product for which a biologics license has been applied, the failure by Dendreon to secure and maintain relationships with collaborators, dependence on the efforts of third parties, and 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. |
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