Canadian Company Completes Phase III Clinical Trials
This data supports that ISA247, at therapeutic doses, is efficacious with minimalside effects." The overall decrease in PASI scores at 24 weeks for the low (0.2 mg/kgtwice daily), mid (0.3 mg/kg twice daily) and high (0.4 mg/kg twice daily)dose groups were 41%, 55% and 70%, respectively. For the placebo patients thatconverted to the mid dose group at 12 weeks the overall decrease in PASI scorewas 62%. The PASI 50 scores at 24 weeks for the mid (0.3 mg/kg twice daily)and high (0.4 mg/kg twice daily) dose groups were 56% and 70%, respectively.PASI 75 scores for the mid and high dose groups were 26% and 49% at 24 weeks.
Patients treated in the mid dose group and low dose group (0.2 mg/kg twicedaily) experienced a continual increase in efficacy over the 24 week periodwith minimal effect on renal function. Both the PASI 50 and PASI 75 scoreswere statistically significant (p less than 0.05) versus placebo. In all dosegroups, PASI scores exhibited good efficacy. Following 24 weeks of treatment, there were no clinically significantchanges noted in the following parameters; hypertension, cholesterol,triglycerides and infectious complications which is consistent with thepreviously released interim report. Additionally, the incidence oftreatment-related adverse events in patients receiving ISA247 was notdifferent to those receiving placebo. The mean decrease in glomerular filtration rate at 24 weeks in the low,mid and high dose groups was 3.0%, 2.8%, and 6.0%, respectively. This meanpercentage change is not clinically significant as it is within normalanalytical and physiological variation. There were no progressive changes inrenal function from 12 to 24 weeks in all dose groups. Of the 451 patientsenrolled in the trial a total of 7 patients, (six in the high dose (7%) andone in the mid dose (1%)) experienced two consecutive greater than 30%decreases in glomerular filtration rate. Patients originally receiving placebothat were subsequently crossed over to the mid-dose group at 12 weeks showedno change in kidney function. Dr. Robert Bissonnette, a principal investigator involved in thePhase III SPIRIT trial stated, "Results from patients treated with ISA247 for24 weeks confirm its safety and efficacy profile in the treatment ofpsoriasis. These results suggest that ISA247 could become one of our firstline systemic treatments for moderate to severe psoriasis." Management will provide an overview of the unblinded Phase III data thismorning at 8:00 a.m. EST/ 6:00 a.m. MST. All Interested parties can access thelive web cast (listen only mode) by going tohttp://www.newswire.ca/en/webcast/index.cgi?companyID=815958378.Alternatively, you may access the web cast through our corporate Web site athttp://www.isotechnika.com. The web cast will be archived for a six month periodthrough the web cast archives at http://www.newswire.ca. The Canadian Phase III Psoriasis (SPIRIT) trial commenced on December 2,2004. The trial was conducted at 32 sites over a 24 week period using orallyadministered ISA247 in psoriatic patients. This randomized, double-blind trial examined the efficacy of three dosing groups of ISA247 (0.2 mg/kg, 0.3 mg/kgand 0.4 mg/kg) administered twice daily compared to placebo with equal numbers of patients assigned to each of the four treatment groups. The 24 week results outlined below are based on a total of 451 patients.
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