Replies to post #87391 on Biotech Values

[genisi]

At 6 months the dimebon treated patients showed a 4 point (not 6) advantage on the ADAS-CoG vs. about 2-3 points seen from historical aricept trials. At 12 months advantage was even greater (6.9 points) .

[iwfal]

MDVN - Dimebon vs SOC

THe dimebon treated patients showed a 6 point advantage on the ADAS-CoG vs. about 2-3 points seen from historical aricept trials.

For the mild to mod patients (the patients in the trial due Jan) in the Russian trial the 6+ point difference in ADAS-cog is the 52 week difference - which would go to my point that the real apparent knock-your-socks-off efficacy is not likely to be apparent in the trial coming due in Jan (since it is a 26 week trial). At 26 weeks the efficacy of Dimebon from the Russian trial is about 4 pts vs placebo on ADAS-cog (reading it off the curves)? Perhaps a little less? That is better than SOC in mild to moderate AD (see below link - although I also have some of the underlying papers) - but not hugely given the noise on the trial.

http://www.ncbi.nlm.nih.gov/pubmed/16437532?ordinalpos=1&itool=PPMCLayout.PPMCAppController.PPMCArticlePage.PPMCPubmedRA&linkpos=2


But, I have to admit that I am viewing this as a statistician - which is probably not how the street will view it. Do you think there is a threshold efficacy that the street would interpret as a break from SOC? 3.5 pts? 4 pts?

I do agree with you that 1yr resutls will be very interesting as they may for the 1st time show disease modification.

What is the proper definition of 'disease modifying'?:

a) The patient stops progressing at all?

b) The patient rate of decline stays permanently better than for untreated patients?

c) The patient stays permanently better than untreated (i.e. never catch up)?

I would suggest that when the AD community talks about 'disease modifying' that they do not all mean the same thing. So it is difficult to predict what will be qualified to claim the title.