The single-center trial called NeoACT, or P07-1 has started enrolling approximately 40 patients. NeoACT is the first of two new Phase II trials of Provenge being initiated in 2008.
Each patient will receive a complete course of active treatment over a one-month period beginning six to seven weeks prior to the patient’s radical prostatectomy. The course of treatment will consist of three infusions of Provenge-two weeks apart.
Multiple safety and efficacy endpoints will be evaluated including the immune response in the prostatectomy specimens and in the peripheral blood. Following radical prostatectomy, patients will be randomized to receive either a booster of Provenge or no booster.
Mark Frohlich, chief medical officer of Dendreon, said: “This trial will help us better understand the mechanism of action and biology of Provenge, as well as evaluate the potential of Provenge in patients at high-risk for recurrence of their cancer following radical prostatectomy.”