From Jan Manarite: To all, Many of you who have advanced prostate cancer may have been watching a drug in development called Abiraterone Acetate. It is not yet FDA approved, but trials look very good, and side effects appear to be very few. Most common side effects are fluid retention (30.5%), and low potassium (17.1%). [...]
GTx, Inc. this weekend presented results of the Capesaris™ (GTx-758) proof of concept pharmacokinetic-pharmacodynamic (PK/PD) clinical trial treating men with advanced prostate cancer, at the Annual Meeting of the Society of Urologic Oncology. Capesaris is a novel oral selective estrogen receptor alpha agonist which GTx is developing for first line treatment of advanced prostate cancer. [...]
Bavarian Nordic A/S today announced that they have received a letter of concurrence from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 study required for product registration for its product candidate, PROSTVAC®, for the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer [...]
This study is currently recruiting participants. Thanks to a heads up from Jan Manarite of PCRI, I have just learned about a trial of Abiraterone Acetate that is currently recruiting participants. In this trial everyone will get abiraterone, nobody will receive a placebo. NO PLACEBO This is a study to collect information on adverse events [...]
— A New Trial Marks Expanded Phase 3 Development of MDV3100 into Earlier-Stage Disease — Medivation, Inc. and Astellas Pharma Inc. today announced the launch of a second Phase 3 clinical trial of their investigational drug MDV3100. This trial marks the expansion of the Phase 3 development of their novel, triple-acting oral androgen receptor antagonist [...]
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) [...]
