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Re: mcbio post# 127911

Saturday, 10/08/2011 8:24:33 AM

Saturday, October 08, 2011 8:24:33 AM

Post# of 252254
KERX AEZS - Something kinda odd went on with the ph ii trial, at least with regards to what shows up on clinicaltrials.org:

1) The trial actually closed enrollment after enrolling multiple cancer types and allowing co-administered drugs of many types for about 2 years. (6 cancer types and thus 6 potential co-drugs)

2) AEZS Investor status gives status on PR/CR/ORR in Aug 2009 for 35 randomized patients per +/- cap.

3) In Sept 2009 it re-opens the trial to "enrollment by invitation" of only CRC patients

But the recently published data doesn't meaningfully expand the number of patients - what happened to the invited patients, or was it only 3 invitees (the latest paper, pointed to by genisi, had 38 patients)?

PS No discussion that I can find is ever made by the companies of the efficacy in the rest of the randomized ph ii (300 patients). So it can be presumed that they were all a complete bust. BUT, on the bright side, even if you adjust the p values for all of those failures the p values are still pretty good (especially in CRC PFS).


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