Biotech Values

[mcbio]

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

Do you mean clinicaltrials.gov here? I believe I've seen other people refer to a .org site before but that address doesn't come up for me and I have always assumed that clinicaltrials.gov is the official site that people reference when checking in on the status of clinical trials. Also, as people have noted before on here, there are often errors with how the trials are presented on this site (e.g. listed as active when they are actually completed, timelines for completion not being accurate, etc.)

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).

Is it possible that the Phase 2 trials in these other cancer patient populations are simply ongoing? AEZS' most recent investor presentation (http://www.aezsinc.com/pdfdyn/Presentation_%20September_2011.pdf ) lists perifosine in Phase 3 for both CRC and MM but also notes Phase 1 and 2 studies ongoing in several other tumor types (CLL, Renal Cancer, and others).