MARKHAM, Canada, November 23 /PRNewswire/ -- Cytochroma Inc. announced today that it has received regulatory approval to initiate a Phase Ia clinical trial in Canada with CTA018, a topical drug for the treatment of mild to moderate psoriasis.

CTA018 is a member of a new class of vitamin D analogues with a dual mechanism of action, called Vitamin D Signal Amplifiers. This proprietary new drug is both a potent inhibitor of CYP24 (the enzyme responsible for the breakdown of vitamin D) and a potent activator of vitamin D signalling pathways. CTA018 will be the first drug with this novel dual mechanism of action to enter clinical development. Preclinical studies have shown that CTA018 inhibits the proliferation of rapidly dividing cells such as human epidermal keratinocytes (skin cells) and is also effective in inhibiting pro-inflammatory cytokine secretion which may be involved in the etiology of psoriasis. Cytochroma anticipates that CTA018 will be more potent than currently marketed vitamin D analogues such as calcitriol and calcipotriol and it is expected to have a greater safety index.

The Phase Ia clinical trial is a randomised, double-blind, within-patient comparison study of various doses of CTA018 involving psoriatic patients. The main purpose of this trial is to establish the local safety and efficacy of CTA018 following topical administration. The clinical trial will be performed utilising a microplaque assay involving the application of a small amount of CTA018 cream to areas of the patient's skin. Comparisons will be made against a placebo cream and a reference cream product currently marketed for the treatment of psoriasis. One of the primary endpoints for this trial will be a clinical assessment of the treated skin using a psoriasis severity index score. A Phase Ib trial is expected to begin early next year and will give further insight into the drug's safety and pharmacokinetics.

Dr. Robert Foldes, President & CEO, said "I am very encouraged with the results of the pre-clinical studies on CTA018. The initiation of human clinical trials for CTA018 will be a tremendous achievement as our first drug in clinical development. This is a significant validation of the potential of the company's technology platform. We expect another two to three compounds to enter clinical development over the next few years."

CTA018 is protected under patents and patent applications exclusively licensed to Cytochroma Inc. from The Johns Hopkins University. Cytochroma Inc., in collaboration with the research group of Prof. Gary H. Posner at The Johns Hopkins University, has discovered a number of proprietary Vitamin D Signal Amplifiers for use in topical and systemic applications. Cytochroma has commenced discussions with pharmaceutical and biotechnology companies with an interest in licensing and co-developing CTA018 for mild to moderate psoriasis.

www.cytochroma.com