17 November 2004
ATL1101 for Psoriasis: Approval for “Proof of Concept” clinical trial
Antisense Therapeutics Limited is pleased to announce that its application to conduct a “proof of
concept” study of ATL1101 in patients suffering from psoriasis has been approved by the Institutional
Review Board and the Ethics Committee of the Clinical Research Organisation that will conduct the
study. Patient recruitment for the study is currently underway.
ATL1101 is a second generation antisense drug designed to block the synthesis of the IGF-1 receptor,
a protein involved in the regulation of cell overgrowth in psoriasis. ATL1101 is being developed as a
cream for the topical treatment of mild to moderate cases of psoriasis.
The trial will take place in Adelaide under the management of CMAX, a Division of the Institute of
Drug Technology Australia Limited.
Proof of Concept – Microplaque Assay
In the “proof of concept” clinical trial (also referred to as Small Plaque Assay or Microplaque Assay),
a relatively small quantity (100 µL) of ATL1101 cream will be applied to areas of psoriatic skin in
patients, once every two days, over a one month period.
A comparison will be made against a placebo cream (cream without the active agent ATL1101), and
also against some reference cream products that are currently marketed as prescription medications
for treatment of psoriasis.
The patients will be monitored over the duration of the trial, and on completion of dosing, for signs of
response and improvement in their skin condition. The final evaluations will include clinical
assessments, as well as assessments of laboratory indices of psoriasis in psoriasis skin samples (punch
The primary end point will be a clinical assessment of the treated skin areas using a severity index
score. The trial will be double-blinded, placebo-controlled, randomised, and two concentrations of
ATL1101 cream will be evaluated in 14 psoriasis patients with mild