Navigation Links
Dendreon Announces Clinical Trial Plans for PROVENGE and DN24-02 at the American Society of Clinical Oncology Annual Meeting

SEATTLE, May 18, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN) today announced three abstracts accepted for poster presentation detailing clinical trial plans for PROVENGE® (sipuleucel-T) and the clinical trial of DN24-02 in bladder cancer at the upcoming American Society for Clinical Oncology annual meeting in Chicago, Illinois.

The three abstracts will be presented on Monday, June 6, 2011, from 8:00 a.m. to 12:00 p.m. CT in the McCormick Place Hall A at the American Society for Clinical Oncology Annual Meeting.

  • Abstract TPS188:  Planned Phase 3 trial – called ACTION – in metastatic, androgen-dependent prostate cancer will compare subjects who receive androgen deprivation therapy (ADT) only with subjects who receive ADT and PROVENGE. The global, randomized, open-label trial will measure overall survival in a targeted enrollment of 1,684 patients, with additional endpoints that include safety, castrate resistant-free survival, chemotherapy-free survival, and quality of life.  
  • Abstract TPS189:  Planned Phase 2 study examining the effects of using PROVENGE before or after androgen deprivation therapy in men with a rising PSA following primary therapy for prostate cancer. The study is targeted to enroll 60 patients and is designed to assess the impact of the two approaches on immune markers.
  • Abstract TPS187:  Phase 2 study of DN24-02 – called Neu-ACT – in patients with surgically resected urothelial cancer, including bladder cancer, who are at a high risk of recurrence. Up to 180 patients will be randomized to receive either standard of care or DN24-02, an active cellular immunotherapy product candidate targeting HER 2/neu that is based on the same platform as PROVENGE. Endpoints include overall survival, disease-free survival, and immune response.

PROVENGE Indication and Safety

PROVENGE is an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

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

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 most common adverse events (incidence greater than or equal to 15%) reported in patients in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in patients in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, 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.

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 group compared with 2.6% of patients in the control group.

For more information on PROVENGE, please see the full Prescribing Information at or call Dendreon ON Call at 1-877-336-3736

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform 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 (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. 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

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 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 Announces Presentation of PROVENGE Data at the 2011 American Society of Clinical Oncology Annual Meeting
2. Dendreon Announces Presentation of Data at the American Association of Cancer Research Annual Meeting
3. Dendreon Announces Webcast Presentations at Upcoming Conferences
4. Dendreon Expands Launch of PROVENGE
5. Dendreon Announces Exercise and Closing of Overallotment Option
6. Dendreon Announces Offering of $500 Million Convertible Senior Notes Due 2016
7. Dendreon Announces Webcast Presentation at J.P. Morgan Healthcare Conference
8. Dendreon Announces Presentation of PROVENGE Data at the American Society of Hematology and the Society of Urologic Oncology Annual Meetings
9. Dendreon Announces Webcast Presentation at Credit Suisse 2010 Health Care Conference
10. Dendreon Reports Third Quarter 2010 Financial Results
11. Dendreon Announces Presentation of PROVENGE Data at the 25th International Society for Biological Therapy of Cancer Annual Meeting
Post Your Comments:
(Date:12/1/2015)... UPPSALA, Sweden , December 1, 2015 /PRNewswire/ ... the International Breast Cancer Study Group (IBCSG, Bern ... Brussels ) to be part of a state of ... new cancer drug.  --> --> ... breast cancer being treated with anti-hormonal therapy in combination with ...
(Date:12/1/2015)... December 1, 2015 Biovicas ... Study Group (IBCSG, Bern ) ... i en klinisk studie av palbociclib, ett nytt ... --> Studien, med namn PYTHIA, kommer följa ... läkemedel i kombination med palbociclib, som tillhör klassen ...
(Date:11/30/2015)... , Dec. 1, 2015 Researchers have ... measures body part thickness and checks for motion, positioning ... a feasibility study presented today at the annual meeting ... (RSNA). Steven Don , M.D., ... Washington University School of Medicine in St. ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... Lutronic, a leading innovator of aesthetic and medical ... the devices for sale in the United States. Clarity is a Superior Dual ... Nd:YAG lasers, into a single platform that is easy to own and operate. ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... SACC-USA through membership and leadership since 2008. Gary Bruce, President of PartnerTech North ... Gary has spent a significant amount of time in Sweden since joining PartnerTech ...
(Date:12/1/2015)... ... December 01, 2015 , ... SonaCare Medical congratulates the University ... Innovation Award on November 18th. This prestigious award recognizes annually organizations that cultivate ... to the medical landscape. , The UCLH team won the award for their ...
(Date:11/30/2015)... ... , ... Trevor and Taylor Crabb have unveiled an exciting new campaign ... the United States. This hybrid crowdfunding campaign is designed to provide the ... addition to offering corporate sponsors with some great marketing deliverables with the brothers for ...
(Date:11/30/2015)... Garden City, NY (PRWEB) , ... December 01, ... ... (NAPW) honors Dale Jones as a 2015-2016 inductee into its ... for leadership in education. NAPW is the nation’s leading networking organization exclusively for ...
Breaking Medicine News(10 mins):