SEATTLE and BOSTON, May 15 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced preclinical data demonstrating that active immunotherapy using Dendreon's proprietary Antigen Delivery Cassette(TM) technology with the antigen carbonic anhydrase IX (CA9), a well-validated and highly-expressed target in renal cell carcinoma (RCC), significantly prolonged survival in RCC animal models. The abstract entitled, "Active Cellular Immunotherapy using CA9-GM-CSF Fusion Protein: A Potent Antigen for Active Immunotherapy," was presented here today at the American Association of Immunology Conference.
Dendreon scientists showed that antigen presenting cells exposed to the CA9 Antigen Delivery Cassette and injected into mice led to a significant prolongation in survival in animals challenged with CA9 expressing tumors. This effect appeared to be sustained with 40 percent of the animals in the drug arm alive at the end of the study compared to zero percent of the animals in the control arm (p-value = .008). The data presented also showed that immunization of mice transgenic for the human HLA-DR4 gene with the CA9 Antigen Delivery Cassette protein could induce CA9-specific T-cells that were restricted to HLA-DR4.
"These results suggest that CA9 is a potent antigen for active immunotherapy," said David Urdal, Ph.D., chief scientific officer of Dendreon Corporation. "These preclinical results are compelling and consistent with the data we have seen with our other immunotherapy products PROVENGE and NEUVENGE and may lead to the development of a third compelling product candidate utilizing our Antigen Delivery Cassette technology."
About CA9
More than 75 percent of primary and metastatic RCCs highly express the transmembrane protein carbonic anhydrase IX, or CA9. In addition, CA9 is expressed in other cancers such as non-small cell lung and breast tumors but not in normal tissue.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company uses its experience in antigen identification, antigen engineering and antigen-presenting cell processing to produce active immunotherapy product candidates to potentially stimulate a cell-mediated immune response. PROVENGE (sipuleucel-T) is Dendreon's lead active cellular immunotherapy in Phase 3 development for prostate cancer. The Company also discovered Trp-p8, a cold receptor and transmembrane ion channel in pre- clinical development, which is over-expressed in breast, prostate, lung and colon cancers. Dendreon expects to leverage its expertise in active immunotherapies to further expand its pipeline and create additional partnering and licensing opportunities. 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 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 differences include risks related to our 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 may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not 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 or commercialization of PROVENGE, our dependence on the efforts of third parties, 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 public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
Dendreon CorporationCONTACT: Monique M. Greer, Sr. Director, Corporate Communications ofDendreon Corporation, +1-206-829-1500
Web site: http://www.dendreon.com//
