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Biotech / Medical : Incyte (INCY) -- Ignore unavailable to you. Want to Upgrade?


To: Biotech Jim who wrote (2832)2/16/2013 9:50:08 AM
From: software salesperson  Respond to of 3202
 
BJ,

Not sure what is going on


perhaps the cc answers below, to some degree?

what is your take on rich levy’s rationale and current study remarks? thanks.


sales

transcript via seeking alpha.

seekingalpha.com

So the rationale for the antitumor effect in pancreatic cancer relates to the basic mechanism whereby, which STAT3 phosphorylation for example is reduced because if you inhibit signaling through JAK it's going to reduce STAT3 phosphorylation. And there are good animal models in pancreatic cancer showing that that is a key mechanism. Now most pancreatic cancers have other imitations, but somehow in ways that have not yet been defined, these work in synergy such that by inhibiting STAT3 phosphorylation you get an antitumor effect and that's has been demonstrated both in cell culture as well as in xenograft models.

Now the other aspect that we're talking about is whether this will prolong survival as a result of improvement in the metabolic status so called treatment of cancer for cachexia. We think both mechanisms may be applied here, if we can increase survival in a solid tumor like pancreatic cancer, I don't think it's critical why that happens as long as you're increasing survival and pancreatic cancer is kind of our model solid tumor disease here, but this seemed like it can be applied to a number of other solid tumors including potentially breast cancer, non-small cell lung cancer, and potentially others as well.

On the futility we're already past that and the study was not stopped for futility. That could potentially have happened if the conditional power was less than 30% and that was not the case and that's basically all we know. At this point in time the study remains blinded.

Yeah. So the study is a randomized study with about 60 to 65 per ARM. So the results would have to be -- and but it is based on survival. So I think you would have to have a very clear survival benefit for regulatory authorities to consider giving an approval or even accepting for filing based on this one study. But if the results were very, very clear, I think it would be difficult for them not to consider making something like this available through labeling considering that there is very limited treatment options here. It’s a highly fatal -- rapidly fatal disease. And if you can improve survival with quality of life there it has to be a possibility, but until we see the data it’s really hard to say.