Sent an email to Epicept but I must be in their black list because they haven't answered. Wonder if anybody here can give me some feedback on this...
-----Original Message----- From: xxxxxxxxxx Sent: Tuesday, December 15, 2009 9:12 AM To: firstname.lastname@example.org Subject: Could you please clarify? Importance: High
Hi Mr. Cook,
I am an Epicept shareholder for over two years and have a question about your latest announcement.
In your Ceplene business update you indicate that you will be starting two studies: Ceplene/IL2 and Gleevec and also Ceplene/IL2 and Vidaza.
In either case, if there are positive results, how are you going to prove that Ceplene had anything to do with it? Why is IL2 in the picture here? It seems to me that these studies are designed to fail to prove what element is making a difference!
The logic thing to do would have been to test Ceplene by itself in combination with Gleevec and Vidaza. If I understood the presentation in Stockholm Ceplene enables IL2 to do it's work, so we should be interested in seeing if Ceplene enables Gleevec and Vidaza to do they jobs. IL2 is just a distraction in this process!
Does anybody have any idea why they are bundling IL2 into the studies?
First of all, thanks jonaustin for your reply, you are pretty much on the money.
I talked with Bob Cook yesterday afternoon and he explained to me that they are pretty sure that Ceplene is not going to bond with Gleevec or Vidaza the way it does with IL2, and therefore are pretty sure that Ceplene alone is not going to bring any benefit. Basically, they are looking for other cancers they can treat with the Ceplene/IL2 combination, not other compounds that Ceplene can bind with (and that was my misunderstanding). Gleevec and Vidaza are in the picture because they are the standard of care for these two cancers. He reiterated that the issue of IL2 alone versus Ceplene and IL2 has been satisfactorily resolved in Europe (where the two new trials are conducted).
Let me see if I can help. The "shares" poster is basically correct.
Ceplene's mechanism (logically derived, but not proven to a degree of absolute certainty) requires IL2 to be efficacious.
That is a known. Therefore, a ceplene alone arm is useless. What is not known, however, is what part of the addtl remission that is achieved via ceplene+il2 therapy is due to IL2 along.
THAT has been a nagging question since a IL2 alone arm was omitted in the original studies. The IL2 alone effect was explained away as being negligible by EPCT via various unrelated piecemeal studies.
In reality, that conclusion can only be arrived at through a head to head comparison. It has been my contention that the FDA will not approve ceplene until the matter is addressed more rigorously in a study with three arms of a) ceplene+IL2 b) IL2 alone, and b) the comparator (either placebo, or standard of care).
You've been invested in epct for "over two years" and you don't know the answer to that question? You don't know the very basics of what it is that they and this drug do and how they (supposedly) work?
That is hilarious! You are the perfect epct investor! Dumb, lazy, and very loyal!