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

y) 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 surroundi
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SOURCE Dendreon Corporation
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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
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9. Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial
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11. Dendreon Expects Interim Data Analysis for Phase 3 PROVENGE IMPACT Trial in October
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