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Re: daved post# 40123

Tuesday, 01/02/2007 4:35:57 PM

Tuesday, January 02, 2007 4:35:57 PM

Post# of 252774
RPRX

You should note that the decision to discontinue the asoprisnil trial was a business decision, and was in fact strongly disagreed with by the independent DSMB.

I would not be at all surprised if some small biotech licences asoprisnil and takes it through phase III with dosing amendments and the provision for intermittent withdrawal. Hell, if I had the money I might consider it myself.

Also note that comparing asoprisnil and Proellex is apples and oranges. Asoprisnil is a mixed agonist/antagonist; both RU-486 and Proellex are pure antagonists. Therefore, if you're going to make comparisons make them with RU-486. Although evidence is mixed for RU-486, the most recent article you cited from the Green Journal (a randomized, controlled, though small trial) suggests it is effective at very low doses (5 mg) and does not elicit hyperplasia.

Even comparing RU-486 and Proellex is comparing apples and oranges to some extent. Beyond the obvious structural differences, RU-486 does not appear to be antiproliferative in the primate endometrial epithelium or stroma. Both Proellex and Lupron provide fairly profound suppression of proliferation.

Note that RU-486 is avaiable in 200-mg tablets right now. Prescribing 5-mg dosages will require either a compounding pharmacy or someone will have to take the 5-mg dosage through clinical trials so that it can get a formal indication. Either way, it eliminates any pricing advantage for RU-486 in endometrosis and/or UF.
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