Isotechnika Inc. (EDMONTON, Alberta, Canada), a biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics for the treatment of autoimmune diseases and for use in the prevention of organ rejection in transplantation, announced that it has received a No Objection Letter from Health Canada and similar approval from the German Competent Authority to conduct a pivotal phase III clinical trial of its lead immunosuppressive, oral calcineurin inhibitor drug candidate, ISA247 (an isomeric cyclosporine A analog mixture), for the treatment of moderate to severe psoriasis. Previous transplant and psoriasis studies have shown that ISA247 is more potent than cyclosporine, with greater tolerability.
The phase III European/Canadian psoriasis trial (ESSENCE) will be performed at 36 clinical centers in Canada, Germany, and Poland (where regulatory approval is still pending) and will involve a total of 500 patients with moderate to severe psoriasis. The 24-week trial will be conducted as a randomized, orally administered placebo and cyclosporine controlled study with 300 patients receiving ISA247 (0.4 mg/kg twice daily), 100 patients receiving cyclosporine (1.5 mg/kg twice daily), and 100 patients receiving placebo. Patients enrolled in the placebo group will be administered ISA247 at a dose of 0.4 mg/kg twice daily following the first 12 weeks. The primary endpoint is superiority in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) score at 12 weeks in the ISA247 treatment group compared with placebo control. Secondary endpoints are noninferiority of ISA247 compared with cyclosporine control in the proportion of subjects achieving a score of "clear" or "almost clear" in the SPGA score at 12 weeks; a 75% reduction in the Psoriasis Area and Severity Index (PASI) score at 12 weeks of ISA247 versus placebo; and maintenance of stable kidney function. Patient enrollment will commence later this year.
ISA247 has completed an extension protocol of a Canadian phase III clinical trial for the treatment of moderate to severe psoriasis and a North American phase IIb human clinical trial for the prevention of kidney graft rejection.
In June 2006, Isotechnika was granted US Patent No 7,060,672 for ISA247. The patent entitled "Novel Cyclosporine Analog Formulations" is the first patent to be issued in this patent family in the United States. These patent claims have been filed in a total of 36 countries. Isotechnika recently received European Patent No EP0991660, the ninth patent to be issued internationally in the ISA247 patent family. Patents relating to these claims have issued in the following countries: Australia, Canada, New Zealand, South Korea, and the United States.
Isotechnika and Cellgate Inc. have signed an agreement granting Isotechnika the option to obtain an exclusive license to develop and commercialize conjugates consisting of Cellgate's patented transporter technology for the topical delivery of ISA247 in patients suffering from mild to moderate psoriasis. Under the terms of the agreement, Cellgate will perform studies to evaluate the feasibility of using their technology to topically deliver ISA247. These studies are expected to be completed by mid-2007. Upon successful completion of the studies, Isotechnika has the option to license the technology from Cellgate to further develop and commercialize conjugates for topical delivery of ISA247.
—A. Techman
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