The summer is coming to a close and I am back, ready to again take on the world. I had the fantastic opportunity of spending almost two weeks in Alaska, a land that is so different from the lower 48. I have to say that I have a new found respect for those individuals who chose to live there, an amazing number who are actually “off the grid.”
Wild life abounds in Denali National Park. I had the opportunity of viewing bears, eagles, moose, a lynx,, sled dogs, sea lion, humpback whales and salmon jumping up a stream. I can report that I was among the 30% who had the opportunity to see Mount McKinley, as a matter of fact I had two separate viewing opportunities! My crowning accomplishment was having seen the aurora borealis in Fairbanks.
Anyway, while roaming around Alaska I had little internet or cell access, so my almost daily writings had taken a back seat. While I was away we did have some significant happenings.
The first, which I have reported, is the FDA approval of MDV3100 (Xtandi). This approval is being viewed as a major leap forward for men with advanced prostate cancer. MDV3100 is an androgen receptor antagonist developed by the pharmaceutical company Medivation. It inhibits the binding of androgens to the androgen receptor (AR) on the prostate cancer cell that in turn inhibits androgens from entering the cell. This is a similar action to Casodex, but is a much more powerful blockade.
In the clinical trials leading to the approval PSA numbers were significantly lowered and survival time was extended by approximately 5 months. All great news for those of us with advanced prostate cancer.
We have also seen good results from another investigational drug that I have also written about, Alpharedin (Radium-233 Chloride). Alpharedin is a radiopharmaceutical that uses alpha radiation from radium-223 decay to kill cancer cells. Radium-223 naturally self-targets bone metastases by virtue of its properties as a calcium-mimic. Alpha radiation has a very short range of 2-10 cells (when compared to current radiation therapy which is based on beta or gamma radiation), and therefore causes less damage to surrounding healthy tissues including bone marrow. We are hopeful that Alpharadin will be approved by the FDA in the first quarter of 2013.
Unlike MDV3100, for which we were able, to arrange a very successful and robust early access program, Bayer (the pharmaceutical company responsible for the development of Alparadin) has not been as flexible as we had hoped. There are now a few sites for early access, but these sites are very restricted on how many men they can treat. We do continue to work with Bayer in growing these sites so additional men are able to take advantage of the drug prior to the formal FDA approval.
The other surprise for me was that yesterday the FDA approval of the production and use of Choline C 11 contrast , a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer. Current PET imaging contrasts re not very sensitive and often provide false negatives. Choline C 11 will allow the detection of a prostate cancer recurrence much earlier in the disease process, allowing earlier treatment. Tomorrow I will write a much more in depth discussion about the use and value of Choline C11.
Dendreon, the makers of Provenge, continue to struggle economically. Despite their excellent immunotherapy they have found it hard to explain their treatment to both survivors and doctors. Among their biggest hurdles is the natural resistance they have been encountering because men who are treated cannot accept that the treatment will not drive down their PSA numbers or the radiologic advancement of their disease. This problem continues to plague them because there is no biomarker that shows that the treatment is effective. Despite this major issue, the numbers from their clinical trials consistently showed that the treatment does extend life.
So, I am back to the grind, bring you news, information and ideas about living with and beating advanced prostate cancer.
Joel T Nowak, M.A., M.S.W.