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Re: Aiming4 post# 5651

Monday, 12/13/2004 1:09:04 AM

Monday, December 13, 2004 1:09:04 AM

Post# of 257624
Re: Lilly/Cortex - significant info...

Aiming: I hope we are talking about the same compound. What LLY canceled was their lead molecule in generalized anxiety disorder (GAD), not Parkinson’s. Here’s my transcript from LLY’s webcast, 3 hours, 45 minutes from the start:

>>
Q [by David Moskowitz of FBR]: Should we take mGlu-Pro off the list?

A: mGlu-Pro… was our lead molecule in our Glutamate platform, was in clinical trials for generalized anxiety disorder. It was a pro drug from our initial molecule. We had over 500 patients on the pro drug… I think with the parent and pro drug together, over 1,500 patients. We actually had an excellent safety profile in patients. We had validated the target as far as anxiety disorders were concerned. But in our lead molecule in our chronic toxicology studies we noticed seizures after repeated dosing of the parent and pro drugs, after long periods of dosing, high doses. But we made a decision to terminate the development of our lead molecule. We haven’t given up on our platform of molecules. We have a platform of molecules we’ve gone back to, and those are in early clinical development, but were not in a position to comment on those molecules right now.
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It’s interesting to compare the above to what was reported in the June 2004 issue of Trends-in-Medicine:

http://www.trends-in-medicine.com/June2004/NCDEU064Rev.pdf

>>
A trial of mGluPro failed, and the molecule is on clinical hold, but the company is not abandoning it. Lilly also has several other candidate mGlu agents in Phase I trials. An official said, “We are trying to find an indication.” Data was presented at NCDEU on LY-354740, a structural analog of glutamate with specificity for mGlu 2/3 receptors that was the basis of Lilly’s mGlu platform. However, LY- 354740 was discontinued due to adverse events. A researcher said, “The problem with LY-354740 is the bioavailability was only 2%-5%, so it is not being developed. But several other mGlu agents in the pipeline are going forward. The platform is going ahead full force…And there is no weight gain with mGlu.”
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