Navigation Links
Dendreon Initiates Phase 2 Trial of PROVENGE in Patients With Localized Prostate Cancer Prior to Surgery
Date:7/16/2008

SEATTLE, July 16 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the Company has initiated a Phase 2 trial of PROVENGE(R) (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for the treatment of prostate cancer, 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, has begun enrolling approximately 40 patients. NeoACT is the first of two new Phase 2 trials of PROVENGE being initiated this year.

Each patient will receive a complete course of active treatment over a one-month period beginning six to seven weeks prior to the patient's radical prostatectomy. The course of treatment will consist of three infusions of PROVENGE-two weeks apart. Multiple safety and efficacy endpoints will be evaluated including the immune response in the prostatectomy specimens and in the peripheral blood. Following radical prostatectomy, patients will be randomized to receive either a booster of PROVENGE or no booster. Patients interested in additional information about this trial may visit http://www.clinicaltrials.gov and use the search term "NeoACT."

"I am pleased to help lead the NeoACT clinical trial, given the therapeutic potential of immunotherapy for prostate cancer," stated Lawrence Fong, M.D., principal investigator of the NeoACT trial and associate professor of medicine at UCSF Helen Diller Family Comprehensive Cancer Center. "This study will provide a unique opportunity to examine the immune response to PROVENGE in actual prostate cancer tissue and to examine the correlation between immune responses in the tissue versus those in the circulating blood."

"Given the evidence of a survival benefit seen in our previous Phase 3 trial, D9901, in patients with advanced prostate cancer, we believe PROVENGE may also have applicability to men with earlier stages of the disease. This trial will help us better understand the mechanism of action and biology of PROVENGE, as well as evaluate the potential of PROVENGE in patients at high-risk for recurrence of their cancer following radical prostatectomy," stated Mark Frohlich, M.D., senior vice president, clinical affairs and chief medical officer of Dendreon. "We are highly focused on taking the steps necessary to get PROVENGE through the FDA approval process in order to get this important immunotherapy to prostate cancer patients with advanced disease who do not have any other reasonable options. We are on track to complete the interim analysis of our ongoing Phase 3 IMPACT trial during the latter half of this year."

About Prostate Cancer

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases expected to be diagnosed in 2008, and approximately 28,660 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.

About Active Cellular Immunotherapy with PROVENGE

PROVENGE may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity.

About Dendreon

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 is also developing an orally-available small molecule called Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. 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.

About UCSF

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. For more information, please see http://www.ucsf.edu.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, 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 for PROVENGE will not support approval for a biologics 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 biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product 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 PROVENGE, 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.


'/>"/>
SOURCE Dendreon Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Presents Preclinical Data Demonstrating Activity of Trp-p8 agonist, D-3263, in Benign Prostatic Hyperplasia
2. Dendreon Presents Data Correlating the Cumulative Potency of PROVENGE(R) to Overall Survival
3. Dendreon Completes Target Enrollment of 500 Patients in Phase 3 IMPACT Study of Provenge(R) For Advanced Prostate Cancer
4. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
5. Rib-X Pharmaceuticals Initiates Phase 2 Trial for RX-3341 In Complicated Skin and Skin Structure Infections
6. MAP Pharmaceuticals Initiates Phase 3 Clinical Trial in Patients With Migraine
7. NeurogesX Initiates Dosing in Phase 1 Clinical Trial for NGX-1998 Capsaicin Liquid Formulation
8. Proteolix Initiates Phase 1b Clinical Trial of Carfilzomib in a Combination Regimen for Patients With Relapsed Multiple Myeloma
9. Cerimon Pharmaceuticals Initiates Phase II Study to Evaluate Simulect(R) (Basiliximab) for Noninfectious Uveitis
10. Orexigen(R) Initiates Second Phase IIb Empatic(TM) Trial on Schedule
11. Echo Therapeutics Initiates Clinical Study of Its Symphony(TM) Transdermal Continuous Glucose Monitoring System in Patients with Type 1 and Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... DIEGO , Feb. 11, 2016 ... groundbreaking cell-isolation method that opens the door to ... until now have been impossible to isolate with ... to isolate specific tumor types in various stages ... genetic variants of these cells that are clinically ...
(Date:2/11/2016)... , Feb. 11, 2016  AcelRx Pharmaceuticals, Inc. ... presentation will be made at the 38th annual ... Wound Care Symposium, which is being held February 14-18, ... conference covers the latest advancements in wound healing, burn ... American Burn Association, Australian-New Zealand Burns Association, Academy of ...
(Date:2/11/2016)... 11, 2016  Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) ... into a Controlled Equity Offering SM Sales Agreement ... Michael Macaluso , Chairman and CEO, stated "During our ... not currently raising money and that we have enough ... and still complete all of our current objectives and ...
Breaking Medicine Technology:
(Date:2/11/2016)... ... 11, 2016 , ... "What holds you back from ... a question as a challenge for his readers to examine the full scale ... (published by Partridge Singapore), Clarke explores the subject with more depth, revealing time-honored ...
(Date:2/11/2016)... , ... February 11, 2016 , ... ... of a master charity program created to assist the people of their local ... closely with nonprofit organizations and community leaders. Their hope is to bring awareness ...
(Date:2/11/2016)... ... February 11, 2016 , ... Talix today announced ... , will be presenting at the 2016 HIMSS Annual Conference & Exhibition, taking ... During his session, “ Coding for Care: Using Data Analytics for Risk Adjustment ...
(Date:2/11/2016)... ... 11, 2016 , ... The annual list showcases the 20 Most Promising SharePoint ... dedication and commitment to the SharePoint ecosystem. A panel of experts and members ... is to recognize and promote technology entrepreneurship. , The survey was made at ...
(Date:2/11/2016)... D.C. (PRWEB) , ... February 11, 2016 , ... ... will be exhibiting at the American Academy of Dermatology Annual Meeting at the ... USA's goal is to raise awareness for both the condition of hyperhidrosis (excessive ...
Breaking Medicine News(10 mins):