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Dendreon Reports Third Quarter 2008 Financial Results

n as D9902B) clinical trial

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
Copyright©2008 PR Newswire.
All rights reserved

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Related biology technology :

1. Dendreon Announces Webcast Presentations at Upcoming Investor Conferences
2. Dendreon Presents Preclinical Data Validating Anti-Tumor Activity of D-3263, a Trp-p8 Agonist
3. Dendreon Announces Webcast Presentation at UBS Global Life Sciences Conference
4. Dendreon Announces Webcast Presentation at Newsmakers in the Biotech Industry Conference
5. Dendreon Initiates Second of Two New Phase 2 Trials of PROVENGE for Prostate Cancer
6. Dendreon Reports First Quarter 2008 Financial Results
7. Dendreon Announces Webcast Presentations at Upcoming Investor Conferences
8. Dendreon Announces Closing of Registered Direct Offering
9. Dendreon Announces $47 Million Registered Direct Offering
10. Dendreon Reports Fourth Quarter and 2007 Year End Financial Results
11. FDA Agrees to Amend Dendreons Special Protocol Assessment for Phase 3 IMPACT Study of PROVENGE
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