Dendreon Breast Cancer Vaccine Generates Strong Immune Response and Shows Preliminary Evidence of Clinical Benefit in Women with Advanced, Metastatic Disease.Business Editors/Health/Medical Writers 25th Annual San Antonio Breast Cancer Symposium BIOWIRE2K SAN ANTONIO--(BUSINESS WIRE)--Dec. 12, 2002 Data presented today at San Antonio Breast Cancer Symposium Dendreon Corporation (Nasdaq:DNDN) today announced that results of a Phase I study indicate that 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, the company'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. for breast, ovarian and colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. , appears to be safe, stimulates immunity and is showing signs of clinical benefit 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. , Her-2 positive breast cancer. The data is presented today at the 25th Annual San Antonio Breast Cancer Symposium in San Antonio, Texas “San Antonio” redirects here. For other uses, see San Antonio (disambiguation). San Antonio is the second most populous city in Texas, the third most populous metropolitan area in Texas, and is the seventh most populous city in the United States. As of the 2006 U.S. by John Park, M.D., University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). San Francisco Comprehensive Cancer Center. In this Phase I study, 16 women received treatment with APC8024 and were evaluated for safety, 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. and exploratory signs of clinical benefit. At three months follow up of 11 evaluable patients, 6 patients (54 percent) had stable disease, and one patient had a partial response with a more than 50 percent reduction in tumor volume. An immune response to APC8024 was detected in 100 percent of evaluable patients. Side effects Side effects Effects of a proposed project on other parts of the firm. were minor, consisting primarily of fever and chills following vaccine infusion. "It is encouraging to see strong immunologic effects, as well as antitumor an·ti·tu·mor also an·ti·tu·mor·al adj. Counteracting or preventing the formation of malignant tumors; anticancer. Adj. 1. effects in an initial trial, which consisted of patients with advanced breast cancer who had largely failed other treatments, including Herceptin," said Park. "These results confirm preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. that have demonstrated APC8024's ability to stimulate the immune system to attack Her-2/neu positive tumor cells. We are hopeful that APC8024 could become another positive example of the potential of vaccines to treat deadly and difficult cancers." The APC8024 vaccine targets tumors that express the Her-2/neu marker. In humans, Her-2/neu is overexpressed in approximately 25 percent of metastatic breast, ovarian, pancreatic and colon cancers. APC8024 consists of a genetically engineered fusion protein, created from intra cellular and extra cellular portions of Her-2/neu, which is combined with a patient's antigen presenting cells. Patients received three vaccinations over the course of a one-month period. The APC8024 approach is similar to the approach used in the development of Provenge(TM), Dendreon's therapeutic prostate cancer vaccine, which recently produced promising results in a Phase III clinical trial Noun 1. phase III clinical trial - 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 . "The clinical data presented today on APC8024 supports the potential broad utility of our therapeutic cancer vaccine platform in multiple cancer types," said David Urdal, Ph.D., president and chief scientific officer of Dendreon. "Our APC8024 anti-Her-2/neu vaccine combined with our Provenge program allows Dendreon to target potential markets valued at more than $4 billion." For more information on Dendreon's clinical trials, please visit the "Clinical" section at www.dendreon.com. About Dendreon Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. The Company currently has a number of therapeutic vaccines in clinical trials, including APC8024. Dendreon's product pipeline also includes monoclonal antibodies and a pathway to small molecules. Dendreon has established important alliances with industry leaders Genentech, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Kirin Brewery Co., Ltd. For more information, visit www.dendreon.com. About Breast Cancer Breast cancer is the most common cancer among women, other than skin cancer. It is the second leading cause of cancer death in women, after lung cancer. Approximately 192,200 women in the United States will be found to have invasive breast cancer in 2001. About 39,600 women will die from the disease. 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 relating to the efficacy of APC8024, the risk that the results of this Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of APC8024 may not be indicative of results obtained in later Phase I, Phase II or Phase III clinical trials of APC8024, risks and uncertainties surrounding the presentation of data to 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. , risks related to Dendreon's relatively limited operating history, risks associated with completing our clinical trials, risks that we may lack the financial resources and access to capital to fund required clinical trials, 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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