Dendreon Corporation (Nasdaq: DNDN), the company that is testing Provenge a potential vaccine for prostate cancer, has started a second of two new Phase 2 trials. The multicenter trial, called ProACT (PROstate Active Cellular Therapy), is enrolling 120 men with metastatic, androgen independent prostate cancer.
The trial protocol calls for all men to receive active treatment but they will be randomized into one of three groups, each receiving different concentrations of the actual immunizing antigen. All subjects will receive three infusions of PROVENGE, each two weeks apart. The trial is designed to measure the effect of antigen concentration on CD54 upregulation, a measure of product potency, as well as the immune response.
Survival data will also be collected and analyzed. The enrollment criteria for this study are the same as the criteria for the original Phase 3 IMPACT Study known as D9902B. The results of this original study are not yet processed. If they are positive, they will serve as the basis for the approval of Provenge by the FDA.
I have written very extensively about Provenge in the past. I urge that you search this blog by putting in the key word “Provenge” into the search box in the upper right corner of this page. You will then see all of my posts which carefully explain how the vaccine is supposed to function, what its historical problems have been and the political implications of the initial postponement of the vaccine has been.
We can only pray that the results will be finalized very soon and the FDA moves with great haste to review the data and finally approve this much need treatment for advanced prostate cancer.
Joel T Nowak MA, MSW