There is some good news on the horizon, or at least we are setting up for the possibility of some future good news. Coming off of the recent news about the very successful phase II trial of CB7630 (abiraterone acetate), Cougar Biotechnology, Inc. has reached agreement with the FDA under a special protocol assessment (SPA) for its planned phase III clinical trial foe men who are chemotherapy-naive, and castration-resistant.
The SPA which is a written agreement between the company and the FDA regarding the design, endpoints, and planned statistical analysis approach of the trial.
The trial will be a randomized, double-blind, placebo-controlled trial of abiraterone plus prednisone in patients who have not yet received chemotherapy.
The positive results from phase II clinical trials of abiraterone were recently presented at the Genitourinary Cancers Symposium in Orlando, FL.
I have written about abiraterone in prior posts, so you can search this blog for information.
If you qualify for this trial I would urge you to stay in touch with its progress as it gets up and running. I will try and keep you informed about it and how to make contact with the trial sponsors as the process becomes up and running.
Based on the phase II results that have been made available I do have hope that we will see positive results. We are in desperate need of additional tools to fight advanced prostate cancer and a new tool before chemo would be very welcomed.
Joel T Nowak MA, MSW