Second phase II trial of PCa immunotherapy begins

Dendreon Corp. has initiated its second of two new phase II trials of sipuleucel-T (Provenge), the company’s investigational active cellular immunotherapy for the treatment of advanced prostate cancer.

The multicenter ProACT (PROstate Active Cellular Therapy) trial has begun enrolling 120 patients with metastatic, androgen-independent prostate cancer to explore the effect of antigen concentration on CD54 upregulation as well as the immune response. Overall survival data will also be collected.

All patients will receive active treatment, but will be randomized into one of three cohorts that will receive different concentrations of the immunizing antigen. Patients will receive three infusions of the agent, each 2 weeks apart. Positive results from this study will serve as the basis for amendment of the company’s Biologics License Application for the investigational therapy.