BURNABY, BC, July 8 /CNW/ - 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 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.
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
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.
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.
ON BEHALF OF THE BOARD
Genhui Chen, Ph.D.
President and CEO
The TSX Venture Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of the content of this news
release. This press release contains forward-looking statements that include
our belief as to the potential of our products. Certain risks and
uncertainties such as our ability to successfully commercialize the products
could cause the Company's actual results to differ materially from those in
the forward-looking statements. The Company thus seeks safe harbour.
For further information:
For further information: Genhui Chen, Tel.: (604) 432-1703, Email:
email@example.com; Yan Chen, Business Development Manager, Tel.: (604)
432-1703, Email: firstname.lastname@example.org