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Welichem Biotech is pleased to announce 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
BURNABY, BC, USA | July 8, 2008 | Welichem Biotech Inc. (the "Company") (TSX-V: WBI) is pleased to announce 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.
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 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. Some patients that were treated with the 2.0% WBI-1001 cream experienced mild skin related adverse events which are common to established topical therapies for psoriasis. There were no serious adverse events in the 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.
Several criteria were used to assess efficacy: physician’s global assessment (PGA), induration, erythema, scaling and body surface area (BSA). Overall, data from the study suggest that WBI-1001 cream is efficacious on psoriasis as demonstrated by greater improvement in PGA, induration, erythema, and scaling when compared with the placebo cream. After 28 days of treatment with WBI-1001, the mean scores for PGA, induration, erythema and scaling for all subjects were reduced from that of the baseline appreciably more for the WBI-1001-treated side than for the placebo-treated side. Improvement in the mean scores for PGAs, induration, erythema and scaling started around Day 14, and was maintained or further increased up to Day 35 (7 days post-dose) in the majority of the treatment groups. The short-term nature of the study did not allow treatment differences to emerge between treatment groups in the BSA criterion.
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.
About psoriasis
Psoriasis is a chronic, autoimmune skin disease characterized by uneven, scaly and often inflamed and itchy patches. It affects some 1–3% of the world’s population and is largely under-diagnosed and under-treated. There is no cure for psoriasis, and patients have to switch therapies frequently over a long period to determine an optimum treatment regime due to drug intolerance, adverse side effects or lack of efficacy of the drugs currently in the market. The psoriasis market had global sales of $1.95 billion in 2005. WBI-1001 targets the market for patients with mild-to-moderate psoriasis, which accounts for 80% of persons with this disease. It diminishes inflammation and plaque rapidly and targets the cause of the disease through selective inhibition of pro-inflammatory cytokines and key pathogenic cells.
About Welichem Biotech Inc.
Welichem Biotech Inc. is a publicly-traded biotechnology company developing therapeutic drugs in the fields of autoimmune, inflammatory diseases and cancer.
SOURCE: Welichem Biotech Inc. |
