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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (884)	10/8/2003 2:03:19 PM
From: Biomaven	Respond to of 3557

This seems to indicate that their is great variability in the "responses" and indirectly also that maybe the results from the 100 mg group were more due to a fluke than to the drug. I think there are two issues that the company briefly touched upon that speak to this issue: 1. The sustained ACR20 and the ACR-N and ACR-N AUC all show a more significant result than the endpoint ACR20. Both these measures are more sensitive and show less random variation (essentially they all incorporate more data points than the straight ACR20). 2. The one objective measure with high reproducibility, the CRP, shows a strong response (p<.004) as well as a clear dose response. This is perhaps the strongest argument that they haven't maxed out yet. I believe the bottom line here is that there is a fair amount of background noise in these ACR measures (as can be seen by the variation in placebo response among the different studies). A 50-patient/dose trial is just not enough to show clear results unless the efficacy is dramatic, which it was not here. I also wouldn't be surprised if they weren't bitten by the same bug that hit the VRTX ICE trial - patients on DMARDs for only a few months that continued to improve because of the DMARD while they were still on the trial (in other words they weren't truly stable). There is some support for this with the higher number PBO patients that improved during the trial. Finally, there seems to be some belief in the industry that the patients in RA trials have gotten tougher to treat - indeed some of the patients here had failed anti-TNF drugs. Clearly the whole population of patients with severe disease that is responsive to anti-TNF drugs is pretty much gone from the trials population. Thus comparisons with existing drugs get harder. Peter P.S. The slides from the presentation are available as a separate PDF - no need to sit through the call to read them.