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Old 06-23-2009, 11:13 AM   #1
Rich66
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Dendreon Initiates Phase 1 Clinical Trial of Small Molecule Targeting TRPM8 in Cancer

Dendreon Initiates Phase 1 Clinical Trial of Small Molecule Targeting TRPM8 in Cancer

Study link: http://www.clinicaltrials.gov/ct2/sh...m=D3263&rank=1


SEATTLE, April 21, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- 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."
About TRPM8
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.
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