designed to assess the safety and efficacy of the investigational
active cellular immunotherapy PROVENGE(R) (sipuleucel-T) in men with
metastatic androgen-independent prostate cancer. While Dendreon
remains blinded to the data, the independent data monitoring
committee (IDMC) reported to Dendreon a 20 percent reduction in the
risk of death in the PROVENGE arm relative to placebo (Hazard
Ratio= 0.80; 95% Confidence Interval [0.610-1.051]). The IDMC
observed no safety concerns and recommended that the study continue
to its final analysis, which is expected to be completed in mid-2009.
* Presented preclinical data on the Company's lead small molecule
candidate, D-3263, which targets Trp-p8 (a transmembrane cation
channel protein also known as Trp-M8), supporting Trp-p8 as a
therapeutic cancer target. Dendreon plans to file an Investigational
New Drug (IND) application later this year with the U.S. Food and
Drug Administration (FDA) to evaluate D-3263 in a Phase 1 dose
escalation study in cancer.
* Initiated a Phase 2 trial of PROVENGE called ProACT (PROstate Active
Cellular Therapy) or P07-2. The multicenter trial is enrolling 120
patients with metastatic, androgen independent prostate cancer.
* Initiated a Phase 2 trial of PROVENGE in men with localized prostate
cancer who are scheduled to undergo a radical prostatectomy. The
single-center trial called NeoACT (NEOadjuvant Active Cellular
immunoTherapy), or P07-1, which is being conducted at UCSF Helen
Diller Family Comprehensive Cancer Center, is enrolling
approximately 40 patients.
* In lieu of Dendreon's regularly scheduled quarterly conference call,
the Company will present at two upcoming investor c
|SOURCE Dendreon Corporation|
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