A new phase 3, registration trial has been announced by OncoGenex Pharmaceuticals, Inc. of its investigational drug custirsen sodium (OGX-011/TV-1011). The trial, for men with metastatic castrate resistant prostate cancer (mCRPC) is referred to as the Prostate Cancer SATURN Trial. This randomized, controlled, trial will include approximately 50 cancer centers and is planned to enroll [...]
As you already know, I am very interested and a strong believer in the future of immunologic therapy. I have written extensively about Provenge and last week I told you about a phase I clinical trial of a Vaccine Therapy for men with progressive stage D0 (non-metastatic) prostate cancer. (http://advancedprostatecancer.net/?p=1419). I want to now let [...]
In yesterday’s post, Provenge, Its Future & A Clinical Trail Alternative for Men with Hormone Dependent Prostate Cancer, I said that I attempted to get into a vaccine trial, but was rejected because I have a history of an autoimmune disease and I have had evidence of some lymph node involvement (stage D1). I want [...]
I have received a number of e-mails from men who are both frustrated that Provenge is not yet approved and who are frustrated that even when approved they will not qualify to get the treatment. I understand the frustration and feel the same way. The first question is will the FDA approve Provenge? Only time [...]
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) [...]