Isotechnika Pharma Inc IPHAF

RE: Biggest Issue for ISA

[labumba]

I think we have some confusion in here about the Cyclosporine ( Neoral )dosing in their past and future Psoriasis trials. I don't know how relevant it is when discussing the safety profile of ISA in relating to Neoral and their past trial data and futre trial without any reference quoted from the journals. If the trial results derived from NEJM ( New England Journal of Medicine )issues, we need the date of the issue. There are issues about Psoriais trial in NEJM and one has to pay by per issue or yearly subscription. Here is what Randall said in the CC " With comparative medications such as Cyclosporine, the data at 1 year shows upward of 20 percent and I think that's, as we discussed, that's an underestimation of the data because all the patients on Cyclosporine trials have either been titrated down or went on intermittent dosing and that's why we're going head-to-head versus Cyclosporine in our European trial " I gathered that they did titrated the drug down from 4mg and (above?)to 3mg and signs of interstitial Fibrosis were found among patients on their long term therapy ( within 1 year or 2 years ? ). ---------------------------------------------- I think the GFR as well as SCr data are extremely essential to support a positive safety profile of the drug. In ISA 48m ext. trial, the mean GFR was remained constant ( those titrated from 0.4 to 0.3 mg had less than 1% GFR change based on within 2 mls per minute-this is a big plus ! ) and no sign of interstitial Fibrosis was found among those drop out. Basically, the primary end point of the head-to-head EU trial is " drug safety " as both ISA247 and Neoral arm are allowed to titrate down from 0.4mg/kg and from 1.50gm/kg respectively. Both GFR and SCr will be the key parameters to decide the outcome plus hypertension side effect issue of Neoral will also give ISA a big edge in the trial,IMO.