Isotechnika Pharma Inc IPHAF

Some renal information

[blog]

In the concentration-controlled de novo renal transplant study, 332 patients are anticipated to be enrolled. Patients will be equally randomized to 1 of 3 doses of ISA247 (0.4, 0.6, 0.8 mg/kg bid) or tacrolimus (0.05 mg/kg bid). The primary objective is non-inferiority in biopsy proven acute rejection at 6 months. Thus far, 43 patients (31 ISA247, 12 FK506) have been enrolled. 2 episodes of acute rejection have been seen in the ISA247 arm (both Banff grades 1b) and two in the FK506 arm(1a and 2a) to date. ISA247 is a systemic immunosuppressant that demonstrates statistically and clinically significant efficacy in psoriasis with minimal impact on kidney function. The de novo renal transplant trial is ongoing. One year data from the psoriasis study and exploratory data from the renal transplant study will be available for presentation at the meeting.