Dendreon Phase 1 Study Results Demonstrate Promising Clinical Activity of APC8024 Immunotherapy in HER2/neu Positive Breast, Ovarian, and Colorectal Metastatic Tumors.Business Editors/Health/Medical Writers BIOWIRE2K 40th 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. Meeting NEW ORLEANS--(BUSINESS WIRE)--June 7, 2004 -- Results presented at ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company -- Dendreon Corporation (Nasdaq:DNDN) today announced results from a Phase 1 study demonstrating promising clinical activity of the company's investigational immunotherapy, 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, in multiple HER2/neu positive 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. solid tumors, including those that are low HER2/neu expressors. The data were presented today at the 40th American Society of Clinical Oncology (ASCO) Meeting in New Orleans New Orleans (ôr`lēənz –lənz, ôrlēnz`), city (2006 pop. 187,525), coextensive with Orleans parish, SE La., between the Mississippi River and Lake Pontchartrain, 107 mi (172 km) by water from the river mouth; founded . A statistically significant (p-value less than 0.0001) 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. was observed in patients with HER2/neu positive breast, ovarian and colorectal cancers treated with APC8024. The results also indicated that APC8024 was well tolerated in all patients who participated in the study, with no treatment-related Grade 3 or 4 adverse events observed. The most commonly reported Grade 1 and 2 adverse events were mild, transient fatigue, rigors and nausea. "It is exciting to see that APC8024 has potential applicability to other solid tumors in addition to breast cancer," said Prema Peethambaram, M.D., Mayo Clinic Mayo Clinic: see Mayo, Charles Horace. Mayo Clinic voluntary association of more than 500 physicians in Rochester, Minnesota. [Am. Hist.: EB, 11: 723] See : Medicine , Rochester, Minnesota. "The strong immunologic effects as well as promising survival data seen among patients with advanced metastatic disease who have failed chemotherapy are very encouraging and warrant further study." Dendreon is currently planning a Phase 2 study of APC8024 in HER2/neu-positive metastatic solid tumors. The poster presentation entitled, "Presenting Cell Based Immunotherapy Targeting HER2/Neu Positive Solid Tumors: Results of a Phase 1 Study of APC8024," described results from a Phase 1 study involving 10 patients with advanced metastatic HER2/neu positive ovarian (4), colorectal (3) and breast (3) cancer. Patients had received a mean of three prior chemotherapy regimens. APC8024 induced a robust cellular immune response cellular immune response n. See cell-mediated immune response. specific to the HER2/neu antigen, and this immune response was statistically significant. In addition, two patients with Stage 4 ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast who received APC8024 had stable disease for 16 and 24 weeks and remain alive at days 325 and 768, respectively. "We are pleased to see the significant immune response with minimal toxicity observed in patients with advanced metastatic breast, ovarian and colorectal cancer," said Robert Hershberg, M.D., Ph.D., senior vice president and chief medical officer, Dendreon Corporation. "APC8024 may provide these patients with a new treatment alternative that is highly targeted, is well-tolerated and has the potential to provide clinical benefit. We look forward to advancing this program into Phase 2 trials." About APC8024 APC8024 is an immunotherapy that targets tumors that express the HER2/neu marker. In humans, HER2/neu is over expressed in a variety of solid tumors, including breast, colorectal and ovarian cancer. APC8024 uses Dendreon's proprietary Antigen Delivery Cassette(TM) technology to genetically engineer the HER2/neu antigen to bind to to contract; as, to bind one's self to a wife s>. See also: Bind antigen presenting cells and stimulate T-cell immunity. In this Phase 1 trial, treatment consisted of three infusions of APC8024 over the course of one month. The APC8024 approach is similar to the approach used in the development of Provenge(R), another targeted immunotherapy that has produced promising results to date in clinical trials for the treatment of advanced 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. . Provenge is currently in a pivotal Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. in men with Gleason scores of 7 or less. About Dendreon 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 monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing and small molecule 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 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 the risks that the safety and/or efficacy results of an early-stage clinical trial will not be confirmed in later clinical trials, the risks that a clinical trial may be suspended due to unacceptable health risks or for other reasons, the risks that a product candidate in clinical trials may not generate safety and/or efficacy results that support further clinical trials or 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 risks that competitors may develop products that are safer and/or more efficacious than a product candidate being studied in clinical trials, the risks associated with dependence on the efforts of third parties and dependence on intellectual property, risks related to Dendreon's limited operating history and risks related to the uncertainty of Dendreon's future access to capital. 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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