MDV 3100

I have received lots of email about the recent press releases regarding this drug. To put it into context, I suggest you re-read the post in which I described several of the new drugs that are in the pipeline and work in different ways on prostate cancer cells. I think of MDV as a form of “super casodex”. Not only does it prevent testosterone (and DHT) from binding to the androgen receptor, but it also stops further activation by preventing the AR from translocating to the nucleus. This is important since AR is a protein that binds to DNA and causes genes to be “activated” or transcribed into messenger RNA. The messenger RNA then goes back to the cytoplasm of the cell and is translated into protein. Many  of the proteins turn out to be involved with telling cells to divide, survive, and do bad things (if it is a cancer cell), like invade other tissues. MDV 3100 also interrupts the interaction of AR with other proteins known as co-activators and co-repressors. All of these additional actions make it superior to Casodex, which can actually be involved in some cases in stimulating the cancer cell rather than suppressing it. (We almost always do “casodex withdrawal” prior to starting patients on an experimental or toxic therapy to rule this out.)

As usual, the pathway from positive findings announced in the press to being able to get a drug is frustrating to many of my patients. We have one trial running at our center in which patients with rising PSA who have never been treated with ketoconazole, who have minimal pain, and who have castrate levels of testosterone and who have positive scans can receive either MDV 3100 or placebo. However, until the FDA approves MDV 3100, there is really no way to obtain the drug outside of clinical trials. There is a full list of our other prostate clinical trials with the various agents here. We also have a number of novel agents in earlier trials in our developmental therapeutics program.

The good news is that “help is on the way”. The frustrations in the process not being faster are painful, but we are doing all we can!

5 Comments

Filed under General Prostate Cancer Issues

5 responses to “MDV 3100

  1. Jim Erickson

    The success of the MDV-3100 cllnical trial is strongly reflected in the price of Medivation stock (MDVN)
    MDVN stock price
    Nov 2 market close 16.50
    Nov 3 market close 40.15
    Some smart guys are speculating major monies on this news

  2. Dan

    Dr Mike,
    Thank You for keeping us
    informed on the progress of these new drugs.
    Now with zytiga and hopefully soon with mdv3100 we have some different options that were not available just a year ago.
    I am wondering if mdv3100 did not work as well with ketoconazole pretreated patients ,and if this is also the case with zytiga/abby.
    Thank You
    Dan
    ps I hope to try DES 1mg as per your study should my e patches/keto fail

  3. Dr. Glode,
    MDV3100 sounds like an excellent breakthrough drug for PCa patients. I quit Casodex once my PSA started to rise. I’m looking forward to a chance for PSA reduction by attacking another pathway for the PCa cells to grow. Do you feel the FDA will fast track MDV3100 and if so, when do you feel MDV3100 will be available? Hopefully the FDA will not drag their feet as they did on releasing Provenge.

    Thanks,
    Craig Becker

  4. George Cooper

    Given the outstanding success of MDV 3100 in the recently prematurely terminated trial, it is a puzzle that there is nothing that I can find as to when it will be available. Does anyone know anything?

    • The process for approval is pretty archane. However, if past approvals are any indication of timing, and assuming that there aren’t toxicities of concern that we don’t know about from published data, I would suspect that MDV 3100 would be approved in the next 6-12 months. This is a very non-official estimate on my part however. Topics like this generate huge interest from the Wall Street community (more even than the science itself), and I would stress that I have absolutely no information or inside knowledge of anything going on at Medivation or the FDA. I think both the agency and the companies always want to get active drugs into the marketplace as soon as possible for all of the obvious reasons. Typically they have worked out very specific early stopping points and approval criteria even before studies are started, then when success is seen, the agency needs to verify the findings before marketing actually happens, and the companies do everything they can to make sure the data is “clean” meaning that there aren’t missing report forms etc. from the study sites.

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