To: Izzy who wrote (4999 ) 7/26/1998 12:52:00 AM From: Peter Singleton Respond to of 6136
Interesting post from the Yahoo IMNR board. Fyi, it's an excellent thread, but time-consuming. There are 4-5 extremely knowledgeable folks who occasionally post there. There's an under-current debate about Remune and the kind of data we're going to see, what's already inhouse but still under wraps, and if there will be an early filing. These guys are speculating that the 32-week HAART data for Remune is in, and the results were more dramatic for Remune + HAART at 32 weeks than at 16 weeks (the data Walker presented in Geneva). Apparently this 32 week data has been submitted as a late breaker for ICAAC in San Diego in September. Net, net, there is a possibility for some big news on Remune that could re-adjust people's expected timeframes, and their valuation of the product.post.messages.yahoo.com @m2.yahoo.com More data - more questionscal59 (39/M/Florida) Jul 26 1998 12:14AM EDT Thanks Kinddr. I was wondering if you had a luncheon recently - I guess you did. The rumorred data seems to be generally consistent with what was expected. However 86% vs 40% seems rather drastic without knowing what the inclusion criteria was. In the INCAS and AVANTI II trials (multinational european study) antiretroviral therapy-naive patients achieved 51% and 60% on the cocktail at 52 wks. In the INCAS trial, peak was 68% at wk 16 and later tapering to 51% at wk 52. In these studies, non-detectable level was defined as 20 not 40/ml. In Dr.Valentine's study non-detectable levels were 86% vs 67% at wk 16 and presumably 86% vs 40% at wk 32. Again in the european studies the general trend of the number of patients on the cocktail with non-detectable levels decreased with time, but not to 40%. One thing was made clear in the european study, patients who had been on antiviral therapy in the past (not triple drug cocktail) had much lower rate of achieving the non-detectable level. So the question is were our patients antiretroviral therapy-naive patients or not? What would the % be if the definition of non-detectable level was changed to 20/ml?