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news.Welichem Biotech has announced the successful completion of and the results from a randomized, double-blinded Phase I clinical trial done in Montreal, Canada, which evaluated topically applied WBI-1001 in 36 psoriasis patients.
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The Phase I study succeeded in meeting both its primary and secondary objectives. The primary objectives were to evaluate the safety and tolerability and to assess the pharmacokinetics of topically applied WBI-1001.
The secondary objective was to obtain an initial evaluation of the efficacy of the WBI-1001 cream. The trial was conducted through six separate treatment groups, each consisting of six patients with mild-to-moderate psoriasis.
All patients within a given treatment group received the same dosage of WBI-1001 on one side of the body and a placebo on the other side. Each treatment group received a unique dosage (0.5%, 1.0% or 2.0%) of WBI-1001 on the affected areas either once or twice a day.
WBI-1001 demonstrated an excellent non-cutaneous safety profile. The 0.5% and 1.0% doses of WBI-1001 exhibited very good skin tolerance in this study. The results of the pharmacokinetic study showed extremely low concentration of WBI-1001 in the blood. There was no evidence that WBI-1001 accumulated systemically upon once or twice daily application over a period of 28 days.
A Phase II study to confirm and further explore WBI-1001 as a topical cream application against mild to moderate psoriasis is planned for 2009.