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MDV3100

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Prostate Cancer
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Posted 2/29/2012 10:01 PM (GMT 0)
Yesterday I sent my first post, "has anyone heard about MDV3100" Received two replies and it seems as if the drug is common knowledge in USA. I live in Australia and was very lucky to be selected for MDVN's Affirm trial which was for patients who had previously received Taxotere, amongst other qualifications.
I am in the 84th week of the trial. What an amazing drug it is! Hallejuhah!!!! When I started the trial my prognosis was bad and my PSA was rising rapidly again, after finishing the course of Taxotere. The cancer had metastisised and I had some bone pain.
Had my 3 monthly Xrays, blood tests etc this week and subsequent consultation with the Trial organisers in Australia.
My PSA is now down to 0.1, my metastises are stable and I have very little bone pain. My health is now A1 except for the fatigue the Trial drug causes. It seems there is a chance the FDA in USA will approve the drug in 2013. I certainly pray this is the case as I am sure it will help many men with advanced Prostate cancer.
I am 69 years old and now have been able to become sexually active again with my partner with the help of Caverject. Praise the Lord life is so good!
Posted 2/29/2012 10:24 PM (GMT 0)
Good for you and thanks for the report. My oncologist is in one of the articles I listed in your original post (N. Vogelzang) and while is not the principle investigator he is one of the providers for the AFFIRM trial. He is a regular guest speaker of our support group and is very high on MDV3100. The results are "a game changer" as he puts it.

Good deal and again thanks for the info. May peace be with you always..

Tony
Posted 2/29/2012 10:25 PM (GMT 0)
Good to hear aka 'Super Casodex' Dr. Sawyers co-inventor on this, it binds to AR receptor way better than casodex is the claims, looks true to form on that. He also has ANR-509 invented and may follow this one, he claims it is even better. Your response appears very good, we hope this gets fast tracked for FDA approval here, so anybody can get it (in theory).
Posted 2/29/2012 10:47 PM (GMT 0)
Hi Tony

So glad to hear you are in the position you are with updates on MDV3100. Not sure of the stage you are at with your Prostate cancer but currently there is a new trial called Prevail for less advanced cases than the Affirm trial

God Bless and keep you Tony
Graeme
Posted 3/1/2012 12:41 AM (GMT 0)
Graeme,
I'm doing amazingly well and very thankful for it. I was just 44 when my diagnosis and treatments revealed advanced disease. I believe that two things were responsible for my remission. One, I have assembled a very strong medical team. And two, It's not my plan and never was to begin with. Simply put I am in a small percentage of stage 3B guys who has sailed beyond the five year mark without ever a rise in PSA.

Keep up your great research. I find that staying current with all the data I can digest to be very helpful. Not just in having a game plan but also in the peace of mind category.

For those interested in the Prevail Trials with MDV3100. Here is the US link for the Clinical Trial...They are still recruiting...

clinicaltrials.gov/ct2/show/NCT01212991

GB2U2, Graeme

Tony
Posted 3/1/2012 9:03 PM (GMT 0)
Hi Tony

Have read the replies to my posts with interest

You are right there is a phase 3 trial called Prevail for those who have not received chemotherapy

Also a phase 2 trial called Terrain comparing MDV3100 with bicalutamide for men who have progressed while on LHRH therapy or following surgical castration

In addition the MDV are currently enrolling patients for a phase 2 trial evaluating MDV3100 monotherapy for hormone naive patients. As yet this is unamed

It is obviously a blockbuster drug and my advice for any of those who qualify to do their utmost to get on a trial. Once on a trial everything is free including xrays, blood tests etc and you receive the drug free forever and a day

God Bless you Tony
Graeme
Posted 3/2/2012 12:02 AM (GMT 0)
Parden my ignorance, but with any of these trials, is it a 50-50 chance that you'll get the drug?
Posted 3/2/2012 1:10 AM (GMT 0)
Jerry that depends. Today we usually have a cohort of 1 in 3 getting the placebo. Also there is something called compassionate care that may allow a patient to enter into the active side of the trial. So yes there is a chance you might get the placebo but the odds are you will get the drug.

Also note: In the Abiraterone trial (Zytiga) there was a similar pattern of success that eventually the FDA waived the placebo arm mid study and suggested that those who were previously in the control arm get the actual drug. And looking at the early success of MDV3100 it is expected to be approved by the end of 2012.

Tony
Posted 3/2/2012 2:15 AM (GMT 0)
Hi Jerry L
In the Affirm MDV3100 trial one in three got the placebo...because of of its outstanding results it was (what is called) "unblinded" and the patients on the placebo where given the option of getting the proper drug. In any trial once the results are positive the organisers are morally bound to do this

GB Graeme
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