Isotechnika Pharma Inc IPHAF

Voclosporin and Kidney Transplantation

[narcissist]

As far as i am aware - pending the initiation of a Phase 3 Clinical trial - there are no transplantation clinical studies currently underway in North America, other than the "Special Access for the Use of Voclosporin for Kidney Transplantation" study which is being supervised by Meredith J Aull, Pharm.D. at Weill Medical College of Cornell University. This study is a compassionate release program where subjects previously participating in the study entitled A Phase 2B, Randomized, Multicenter, Open-Label, Concentration Controlled, Safety Study of ISA247 and Tacrolimus (Prograf®) in denovo Renal Transplant Patients (ISA05-01)" may be eligible to continue to receive voclosporin despite the Phase 2B study being terminated by the sponsor. Under the compassionate release program, subjects previously taking voclosporin may continue to receive the study medication until the drug is FDA-approved and commercially available in the United States. The phase IIb study had 334 patients enrolled. A sub-set of those patients (I am not sure of the number) continue to receive voclosporin on compassionate grounds. If we are looking for news in the shorter term (as opposed to phase 3 results which will be a long time in coming since there is as yet no phase 3 study) it might well be in publications related to the longer term efficacy of those subjects who continue on voclosporin. You can track this expanded study at the ClinicalTrials.gov web site by searching for voclosporin or referencing study NCT01236287.