Navigation Links
Dendreon Announces Presentation of PROVENGE Data at the American Urological Association Annual Meeting
Date:5/31/2010

SEATTLE and SAN FRANCISCO, May 31 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced the presentation of safety data from the integrated analysis of four randomized PROVENGE® (sipuleucel-T) clinical trials of an autologous cellular immunotherapy in prostate cancer at the 105th Annual Scientific Meeting of the American Urological Association (AUA) in San Francisco.

"The approval of PROVENGE provides us with an important new, front-line option for men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer," said Simon Hall, M.D., director of the Barbara and Maurice Deane Prostate Health and Research Center at Mount Sinai Medical Center.  

The analysis includes data from four randomized trials in patients with either metastatic castrate resistant prostate cancer (Studies D9901, D9902A, IMPACT) or androgen dependent prostate cancer (Study  P-11) that were integrated to examine the safety profile of PROVENGE across the four studies. The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The abstract presented was a poster presentation by Dr. Hall, titled "Integrated safety results from 4 randomized, double-blind, placebo-controlled studies of sipuleucel-T (abstract #1000875)."

PROVENGE is the first autologous cellular immunotherapy to be approved by the U.S. Food and Drug Administration for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE Important Safety Information

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

In controlled clinical trials, serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events.  Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting.  No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

The most common adverse events (incidence greater than or equal to 15%) reported in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache. 

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1,500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE arm compared with 2.6% of patients in the control arm.

About Active Cellular Immunotherapy

PROVENGE is classified by the FDA as an autologous cellular immunotherapy. It is designed to be an active cellular immunotherapy. Active cellular immunotherapy is designed to stimulate a T-cell response to cancer cells. An immune response is started by a specialized class of immune system cells called antigen-presenting cells (APCs). APCs take up antigen from their surroundings and process the antigen into fragments that are then displayed on the APC surface. Once displayed, these antigens can be recognized by specific classes of immune cells called T lymphocytes (T-cells), which are activated as a result of their engagement with APCs and combat disease by seeking antigen-bearing cells directly. PROVENGE is designed to target the prostate cancer antigen prostatic acid phosphatase (PAP), an antigen that is expressed in more than 95 percent of all prostate cancers.

About Dendreon

Dendreon Corporation is a biotechnology company targeting cancer and transforming lives through the discovery, development, commercialization and manufacturing 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 in a variety of tumor types. Dendreon's first autologous cellular immunotherapy product, PROVENGE® (sipuleucel-T), was approved by the FDA in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Dendreon also is developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer. The Company is headquartered 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 www.dendreon.com

This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon's business and prospects, including commercialization of PROVENGE. 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 www.sec.gov. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.


'/>"/>
SOURCE Dendreon Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Presents Updated IMPACT Results Confirming PROVENGE Improves Overall Survival in Patients With Metastatic Castrate-Resistant Prostate Cancer
2. Dendreon Reports Fourth Quarter and 2009 Year End Financial Results
3. Dendreon Announces Election of Ian Clark and Pedro Granadillo to Board of Directors
4. Dendreon Reports PROVENGE Regulatory and Commercialization Progress and Future Pipeline Plans at Analyst Event
5. Dendreon Presents Preclinical Data Demonstrating Activity of TRPM8 Agonist, D-3263, in Benign Prostatic Hyperplasia
6. Dendreon Initiates Phase 1 Clinical Trial of Small Molecule Targeting TRPM8 in Cancer
7. Dendreon to Hold a Conference Call Tomorrow at 9:00 AM ET to Discuss Final Results of Phase 3 PROVENGE IMPACT Trial
8. Dendreon Presents Integrated Analysis of Clinical Data from NEUVENGE Trials at Chemotherapy Foundation Symposium
9. Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial
10. Dendreon to Hold a Conference Call Today at 9:00 AM ET to Provide an Update on Interim Results of Phase 3 PROVENGE IMPACT Trial
11. Dendreon Expects Interim Data Analysis for Phase 3 PROVENGE IMPACT Trial in October
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... On Wednesday, March 22, ... at 5,821.64, up 0.48%; the Dow Jones Industrial ... and the S&P 500 closed at 2,348.45, slightly ... out of nine sectors ended the day in ... on the following Medical Instruments & Supplies equities: ...
(Date:3/23/2017)... 2017 Piramal Pharma ... gibt die Ernennung von Stuart E. Needleman ... globalen Pharmazeutikkunden eine einmalige integrierte End-to-End-Serviceplattform an ... für das erfolgreiche Wachstum und die Umsetzung ... Herr Needleman dafür verantwortlich sein, alle globalen ...
(Date:3/23/2017)... 23, 2017 Merrimack Pharmaceuticals, Inc. (NASDAQ: ... patient in a Phase 1 study of MM-310 in ... encapsulates a novel taxane and targets the EphA2 receptor, ... of many major tumor types, including prostate, ovarian, bladder, ... of this study is an important step in evaluating ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... The StayWell Company ... NCQA. The accreditation covers StayWell’s asthma, coronary artery disease, congestive heart failure, chronic ... organizations that have excellent programs for the delivery and improvement of disease management ...
(Date:3/23/2017)... , ... March 23, 2017 , ... ... families and businesses of the greater Fort Collins area, has unveiled a collaboration ... ongoing community involvement program. Donations to this worthy cause may now be made ...
(Date:3/23/2017)... ... , ... ?This conference will prominently feature 150+ Hospital and Health System Executive Speakers including: , ... , 43rd President of the United States of America: George W. Bush , ... Out of the Ring: Sugar Ray Leonard , JD, Chairperson, McGuireWoods LLP: Amber ...
(Date:3/23/2017)... ... March 23, 2017 , ... ... improve all aspects of people’s health and nutrition, announced its product Leyzene is ... , Natural Subsistence develops nutritional supplements that help people improve all aspects of ...
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... The American ... 2017 marks the 40th Anniversary of ABQAURP’s dedication to Health Care Quality and Management ... who have contributed not only to the association, but also to the Health Care ...
Breaking Medicine News(10 mins):