Welichem Succesfully Completes Phase I Clinical Trial
BURNABY, BC, July 8, 2008 /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
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.
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: Genhui Chen, Tel.: (604) 432-1703, Email: gchen@welichem.com; Yan Chen, Business Development Manager, Tel.: (604) 432-1703, Email: investors@welichem.com
Posted: July 2008
