- Data Presented at American Urological Association Annual Meeting -
SEATTLE and ORLANDO, Fla., May 21 /PRNewswire-FirstCall/ -- Researchers from Dendreon Corporation (Nasdaq: DNDN) today presented preclinical data demonstrating the potential of D-3263, Dendreon's orally bioavailable small molecule, which targets Trp-p8 (a transmembrane cation channel protein also known as Trp-M8), to treat benign prostatic hyperplasia (BPH).
The abstract (#2041), "Preclinical Validation of the Trp-p8 Ion Channel as a Target for Benign Prostatic Hyperplasia," is being presented at the American Urological Association's 2008 Annual Meeting in Orlando, Fla., on Wednesday, May 21, 2008, at 2:50 PM ET.
In a preclinical study, BPH was induced through subcutaneous injection of testosterone propionate (TP). One week prior to initiation of testosterone, either D-3263 or finasteride, a current treatment for BPH, was administered daily for four weeks. Following treatment, blood was sampled, prostates were collected and weighed, and cross sections were stained with Trp-p8 antibody.
"We are encouraged by these data which demonstrate the potential for D-3263, our lead small molecule targeting Trp-p8, to serve as a drug candidate for the potential treatment of BPH -- a disease affecting a substantial number of men between 50 and 60 years of age," said David Urdal, chief scientific officer of Dendreon. "We had previously shown that D-3263 specifically kills cancer cells that express Trp-p8, and we look forward to filing an investigational new drug application later this year to initiate a study examining D-3263 in advanced cancer, including prostate cancer."
Results showed that the BPH-induced prostates expressed significantly higher levels of Trp-p8 compared to the normal prostates. In comparing untreated BPH-induced prostates to those treated with D-3263, treatment with D-3263 resulted in a 39 percent reduction in prostate weight compared to control (p=0.004). In addition, treatment with D-3263 resulted in a 98 percent reduction (2221.2 pg/ml versus 43.1 pg/ml) in plasma dihydrotestosterone (DHT) levels (p=0.004) suggesting D-3263 is affecting androgen metabolism, which is a known stimulant for BPH and prostate cancer. These effects were seen in a dose-dependent manner, achieving efficacy comparable to finasteride. Histopathological examination post treatment with D-3263 indicated that reduction of prostate size and weight was due to a return to normalcy. Changes in Trp-p8 expression and plasma DHT levels correlated with both efficacy and dose.
Trp-p8 (also known as Trp-M8) was identified through Dendreon's in-house discovery efforts. It is an ion channel that is triggered by cold temperatures and small-molecule agonists. In normal human tissues Trp-p8 is expressed predominantly in the prostate where it is over-expressed in BPH and prostate cancer, as well as a range of other cancers including breast, lung and colon. Dendreon has synthesized bioavailable small molecule agonists that activate the Trp-p8 ion channel and induce cell death. The lead molecule, D-3263, is undergoing preclinical evaluation in anticipation of an investigational new drug application to be filed with the U.S. Food and Drug Administration for clinical evaluation in cancer patients.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics to fight cancer. 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. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. 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 http://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, 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 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 products, 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 http://www.sec.gov.
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