Isotechnika Pharma Inc IPHAF

RE: Two renal 2b presentations posted

[go4future]

IMO it has been my impression that the Promise Renal 2B results and associated trial demographics published tended to put Voclosporin at a disadvantage to the trial participant demographics associated with Tacrolimus. One of the slides in the 2nd June 2 presentation showed the demographic breakdown as well as a related article which discussed this aspect in another sponsored Transplant Trial.

For example in the Promise 2B trial it showed demographics factors favoured Tacrolimus for Reciepient Race (Black), Diabetes Mellitus Pre-Tx and % Deceased Donors.

I found an interesting arcticle (Dec 2007, but still applicable) that talked about trial demographics and results that were undrstated. The article was related to research trial on "Post-kidney transplant immunosuppression with low-dose tacrolimus (Prograf) may offer some short-term advantages over other regimens, researchers here found". The Doctor involved was independent from the sponsored study with the trial sponsor being, you guessed it was Roche.

Some quotes taken from the article (URL below are as follows:

"Serious adverse events were most frequent with sirolimus (53.2% versus 43.4% to 44.3%), but the proportion of
patients with at least one adverse event was similar across groups (86.3% to 90.5%)."