In Development
Voclosporin a calcineurin inhibitor, a novel Cyclosporine analog, has successfully completed a Canadian Phase 3 trial for the treatment of moderate to severe psoriasis. Voclosporin is currently being investigated in a combined European/Canadian Phase 3 psoriasis trial and a North American Phase 2b trial for the prevention of organ rejection following kidney transplantation.
Isotechnika's partner, Lux Biosciences, initiated pivotal trials of voclosporin in uveitis in February, 2007. The pivotal trial program, which consists of three controlled, double masked studies, is investigating the use of voclosporin (referred to as LX211 by Lux) in different forms of active uveitis in addition to maintenance of quiescent disease.
Lux Biosciences received Fast-Track designation from the FDA in August, 2007. Fast-Track designation will provide various means to expedite the development and review of voclosporin. The process could be facilitated through meetings and other correspondence with the FDA reviewers, consideration for priority review, and the abiity to submit portions of the New Drug Application (NDA) early for review as part of a "rolling" submission.
Voclosporin has been granted orphan drug status by the FDA. Furthermore, on August 1, 2007, Isotechnika announced that the European Agency for the Evaluation of Medicinal Products (EMEA) committee for Orphan Medicinal Products has adopted a positive opinion on orphan medicinal product designation for voclosporin for the treatment of chronic, non-infectious uveitis.
TAFA93 is a novel prodrug of the mTOR inhibitor Rapamycin. TAFA93 has been designed to attenuate the unfavorable pharmacokinetics and side effects of Rapamycin which presently limit its broader use. mTOR inhibitors are currently used in the prevention of organ rejection in transplantation, in the treatment of autoimmune and oncological diseases, and as a component of coated stents for the treatment of coronary artery disease. TAFA93 has successfully completed Phase 1 clinical trials.
Immunosuppressive Drug Market Potential
