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Isotechnika says phase III psoriasis trial meets primary, secondary endpoints
By E. Janene Geiss
Philadelphia - Isotechnika Inc. announced Monday that data from the company's Canadian phase III psoriasis trial for its lead immunosuppressive drug, ISA247, has met its primary and secondary efficacy endpoints.
The efficacy endpoints were all met at 24 weeks and were achieved with minimal side effects, according to a company news release.
We are extremely pleased to have met our endpoints and achieved a dose that demonstrates a continual increase in efficacy with minimal effect on renal function," said Randall Yatscoff, Isotechnika's president and chief executive officer, in a press release.
"Again, this positions us well for future clinical trials with ISA247. This data supports that ISA247, at therapeutic doses, is efficacious with minimal side effects," Yatscoff added.
ISA247 is an immunosuppressant currently in an extension protocol of a Canadian phase III human clinical trial for the treatment of severe to moderate psoriasis. It also has successfully completed a phase IIa trial for kidney transplantation.
In the psoriasis trial, mid- and low-dose groups continued improvement in PASI scores from 12 to 24 weeks and no clinically significant differences in mean serum creatinine and glomerular filtration rate were observed among the four treatment groups at 24 weeks, officials said.
Following the treatment, there were no clinically significant changes in hypertension, cholesterol, triglycerides and infection complications, which is consistent with the previously released interim report. Additionally, officials said, the incidence of treatment-related adverse events in patients receiving ISA247 was not different to those receiving placebo.
The trial began Dec. 2, 2004 at 32 sites on 451 patients using orally administered ISA247.
Isotechnika is a biopharmaceutical company based in Edmonton, Alta.
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