Press Release:
Isotechnika Achieves Target Enrolment for Phase III Psoriasis Trial
Press Release
News Article February 2005
EDMONTON, Canada, February 10/PRNewswire/ -- Isotechnika Inc. announced today that the original target of 400 subjects for its Canadian Phase III psoriasis trial for its lead immunosuppressive compound, ISA247 has been reached. Due to the enthusiasm of our investigators and the willingness of patients to participate in the trial, the Company will allow approximately 80 additional patients to receive drug treatment. Total enrolment for the trial will therefore be approximately 480 patients.
The trial, which commenced on December 2, 2004, is currently being conducted at thirty-two centres across Canada and involves patients with moderate to severe psoriasis. Patients have been randomised to one of the four dosing arms; high dose (0.4 mg/kg twice daily), mid dose (0.3 mg/kg twice daily), low dose (0.2 mg/kg twice daily) and placebo. Subsequent to the first 12 weeks, those patients who received placebo will be administered the mid dose range dose of 0.3 mg/kg twice daily for the remaining 12 weeks of the study.
"Our willingness to allow additional subjects into the trial was based on numerous requests received from our investigators and those patients suffering from psoriasis," stated Dr. Randall Yatscoff, Isotechnika's President and Chief Operating Officer. "Requests to allow for additional psoriasis patients to be added to the trial likely speak to the unmet medical need of trying to find safer and efficacious drug therapies. The Company anticipates release of interim results, which is based on 300 patients completing the first twelve weeks of treatment, to the investment and scientific community in the third quarter of 2005 with final results expected in early 2006."
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