Isotechnika Pharma (TSX:ISA) expects a decision shortly from the International Chamber of Commerce (ICC) Court of Arbitration on its right to terminate a development, distribution and license agreement with ILJIN Life Science Co.
Isotechnika made the disclosure in its third quarter report. It terminated the accord with ILJIN last January.
In addition, Isotechnika partner Lux Biosciences completed patient enrollment in July for its Phase 3 clinical trial using voclosporin, which Lux has branded as Luveniq for the treatment of non-infectious uveitis, a leading cause of vision loss and long-term disability.
Lux anticipates that data from the Phase 3 trial will be available in the first quarter of 2013.
Lux also anticipates that the results from this trial, if positive, will address the FDA’s request for additional clinical information as part of the complete response letter for the companies’ new drug application. The NDA re-submission will also receive priority review by the FDA.
Regarding its portfolio of cyclophilin antagonist molecules (NICAMs), which are being tested by the allergy and infectious disease arm (NIAID) of the NIH, Isotechnika said several NICAM compounds have been found to be highly active in primary in vitro assays against a number of important viruses, including Hepatitis C virus, Human Papillomavirus, Human Cytomegalovirus and Varicella-Zoster virus, the causative agent of shingles.
“Some of the compounds are currently undergoing secondary level in vitro testing, through NIAID’s contract testing laboratories, towards selection of lead drug candidates for preclinical development,” Isotechnika added.
