FDAnews
www.fdanews.com/articles/73515-dendreon-completes-enrollment-in-phase-iii-protect-trial

DENDREON COMPLETES ENROLLMENT IN PHASE III PROTECT TRIAL

June 21, 2005

Dendreon has completed enrollment in its Phase III PROTECT clinical trial of Provenge in men with non-metastatic androgen-dependent (hormone-sensitive) prostate cancer. Provenge is Dendreon's investigational immunotherapy for the treatment of prostate cancer.

The PROTECT (Provenge Treatment and Early Cancer Treatment) study is a double-blind, placebo-controlled Phase III trial designed to evaluate Provenge in men with non-metastatic androgen-dependent prostate cancer. It is measuring PSA progression and the onset of metastatic disease. At the time of biochemical progression, men become eligible for one booster of either Provenge or placebo. The study is being conducted at 19 institutions in the U.S. and has enrolled more than 170 men.