SEATTLE, April 21 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the Company has enrolled the first patient in a Phase 1 clinical trial of D3263 in patients with advanced cancer. D3263 is Dendreon's lead small molecule drug candidate designed to target TRPM8 (a transmembrane cation channel protein) in cancer cells and induce cell death. The trial is an open-label, dose-escalation study evaluating the safety and pharmacokinetics of orally-administered D3263 in patients with solid tumors that are refractory to standard therapies.
The Phase 1 trial will enroll three to six patients per cohort during the dose escalation phase of the study. An expansion cohort may be enrolled following determination of the maximum tolerated dose. The primary endpoint of the study will be safety, but patients also will be evaluated for anti-tumor activity as well as tolerance of the drug in order to determine the optimal schedule and level of dosing. The trial has been initiated at South Texas Accelerated Research Therapeutics (START) in San Antonio Texas under the direction of Dr. Anthony W. Tolcher.
"D3263 is a drug candidate that has potential applicability to multiple types of cancer as well as to benign prostatic hyperplasia (BPH)," stated Mark Frohlich, M.D., senior vice president of clinical affairs and chief medical officer of Dendreon. "The ability of D3263 to inhibit growth of TRPM8 expressing tumors in preclinical studies coupled with its oral bioavailability make it an appealing product candidate to advance into human clinical trials."
Patients interested in additional information about this trial may visit www.clinicaltrials.gov and use the search term "D3263."
TRPM8 (also known as TRPP8) was identified through Dendreon's in-house discovery efforts. It is an ion channel that is triggered by cold temperatures and small-molecule agonists and belongs to the melastatin subfamily - one of seven subfamilies of TRP proteins. In normal human tissues, TRPM8 is expressed predominantly in the prostate, a gland in the male reproductive system. It is over-expressed in prostate hyperplasia and multiple types of cancer including prostate cancer, breast cancer, colon cancer and lung cancer. In recent years, it has emerged that TRP channels play a diverse and key role in cell biology and in pathology. Dendreon has synthesized small molecule agonists including D3263 that activate the TRPM8 ion channel and induce cell death.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon also is developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as BPH. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN. 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 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 existing clinical trials or from additional clinical trials will not support approval for a marketing 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 marketing license has been applied, the risk that the results of a clinical trial 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, 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.
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