InvestorsHub Logo
icon url

neuroinv

11/30/06 3:43 PM

#2345 RE: gfp927z #2344

<<Bladerunner, One could just as easily ask why Organon would put a different AMPA upmodulator into the clinic if they're so happy with Org-24448? >>

No, that's incorrect. Everyone wants a backup compound in the clinic. CX717 shows why, but there have been many other programs where the first lead flamed out. Secondly, Org26576 may have a slightly different profile of activity, perhaps it performed better in the forced swim test or some other animal depression model. It doesnt say anything about negative perceptions of Org24448--but Blade is correct, if Organon thought there was a class effect, they wouldnt have doubled their exposure.
'
<< I don't think it's been firmly established yet that Org-26576 is definitely a Cortex developed compound.>>

True. It is governed by the agreement for sure--it probably came from the menu of choices Organon took from Cortex, but I'm not certain of its provenance.

<< As we saw, Servier decided to go ahead with their own non-Cortex compound.>>
You'll be interested to know that Servier recently discontinued (for the second time) that MCI trial with S18986 due to toxicity issues (no, not the CX717 issue)--S18986 is probably dead.

<<All I'm saying is that based on the numerous landmines we've hit over the past year, we should be careful with our assumptions, particularly the rosy type.>>

Who can argue with that? But let's not become overly paranoid, either.

<<if they're doing their job right, the FDA SHOULD want to see additional tox data on Org-24448>>

Could be. But if the FDA was thinking of this as a possible class effect, they've had 8 months since they put the clinical hold on CX717 to take action vis-a-vis Org24448. Instead, the clinical trial program has continued. That by no means guarantees that the FDA couldnt shift course--but Organon has (they aren't brain dead, after all) replicated some of those tox studies with Org24448, so that if the FDA asks, they have the data ready.

NeuroInvestment