Saturday, October 13, 2007 1:26:05 PM
My column on "manopause" stocks prompted a couple of questions. Jon. R. asks, "Why has the FDA not also raised the bar on Nebido as they have done with Repros?"
As I wrote this week, Repros Therapeutics is in a bit of a bind with its testosterone-boosting drug Androxal because it hasn't yet reached agreement with the FDA on an approval-worthy clinical endpoint for a phase III study.
Androxal works by stimulating a man's body to produce more of his own testosterone. That puts the drug in a different category than currently marketed testosterone replacement products, including Indevus Pharmaceuticals and its long-acting, injectable testosterone replacement Nebido.
On the same topic, Dick F. asks, "Do any of these testosterone companies mention anything about artificial testosterone possibly causing cancer?"
Great question. Yes, the subject did come up at the UBS conference I attended last week because it is, or has been, a concern. There were two doctors -- a urologist and an endocrinologist - speaking at the conference, and both downplayed the testosterone replacement-cancer link.
At this point, there is no clinical data to suggest that men who use a testosterone replacement are at any greater risk for developing cancer, specifically, prostate cancer, the docs said. It is well understood that testosterone "feeds" prostate cancer, which is why prostate cancer patients are put on hormonal therapy to deplete testosterone. But there is no evidence that circulating testosterone causes prostate cancer to develop.
http://www.thestreet.com/s/feuersteins-biotech-stock-mailbag/newsanalysis/biotech/10384286.html?puc=....
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