I'm really not interested in rehashing the same tired argument over the P2 trial design but if all mTors were the "same", as you put it, then I would have expected that the everolimus P2 sarcoma trial results would have been similar to ridas but they weren't even close. How about we just agree to disagree and wait for the final results?
As far as the difference between mTors, you can find the CEO's pertinent comments below:
"The biggest difference perhaps between temsirolimus and everolimus, and in turn that translates into a difference versus deforolimus, is that temsirolimus Torisel, the Wyeth drug, is predominantly – well, it is approved as an IV formulation given generally weekly, and is a – although there are some data in an oral tablet form, there are very limited data on temsirolimus given orally and it is largely developed and now marketed as an IV formulation.
On the other hand, everolimus is in a tablet form, using the dose and schedule that they put forth which is a daily dose of 10mg a day, and so there the differentiation with ARIAD’s product we are developing with Merck, namely deforolimus, is that our dose and schedule could not be more different. In fact, I would say the everolimus versus deforolimus difference in dosing schedule is as great as the difference between oral and IV.
We are dosing patients at 40mg a day five out of seven days, which results in very high exposure, very high and reliable inhibition of mTOR activity in pharmacodynamic studies, substantial blood levels and circulating levels of inhibitory mTOR activity, a different safety profile in terms of the incidents and timing and severity of mouth sores, you know, and I can go on.
So there are differences and there are similarities among these three drugs and I think until you have a head to head comparison in a randomized trial, it is very difficult to make real comparisons of their efficacy or even their safety profile. But on all fronts, we believe that deforolimus has a very solid and well-accepted both safety and efficacy profile based on the available clinical data to date, but that has really got to get assessed in a prospective randomized trial, which is what is going on."
