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

Thursday, May 19, 2011 General News J E 4
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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 www.provenge.com 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 http://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

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