Novel topical treatment of psoriasis

Cytochroma Inc. today announced results from a Phase Ia clinical study for CTA018, a novel vitamin D analog developed for the treatment of psoriasis.

The study, involving 17 healthy subjects with mild to moderate plaque psoriasis, was designed to characterize the local efficacy and safety of three concentrations of CTA018. Results indicate that all three doses appear to reduce the severity of psoriasis plaques with no local tolerability concerns. The Company is currently concluding a Phase Ib study with CTA018 to assess the drug's systemic safety and pharmacokinetics.

"The data from the Phase Ia study is very encouraging," stated Jukka Karjalainen, M.D., Ph.D., Vice-President of Drug Development at Cytochroma. "We were able to demonstrate the drug's effectiveness in reducing psoriasis, and that it did so without any symptoms or signs of skin irritation is particularly promising. Treatment-related skin irritation is one of the main complaints of psoriatic sufferers using current treatments."

The Phase Ia study was a randomized, double-blind, within-subject comparison of three doses of CTA018 (3, 10, and 20 (micro)g/g), corresponding cream base (vehicle control) and an active control (0.1% betamethasone). Each subject received all five creams applied topically to the skin using a microplaque assay every 24 hours for 13 consecutive days with a subsequent follow-up 7 days post treatment. There were no adverse events that were considered to be probably related to treatment. All three doses were efficacious in reducing the severity of psoriasis, and moreover showed significant residual efficacy one week after the treatment compared to placebo.

Based on the data from the Phase Ia study, together with data obtained in the Phase Ib study and nonclinical studies, Cytochroma anticipates initiating a Phase II clinical trial with CTA018 in the fourth quarter of 2005.

CTA018 is a novel vitamin D analog with a dual mechanism of action. It is a strong activator of the vitamin D signaling pathway and also a potent inhibitor of CYP24 activity (the enzyme responsible for the breakdown of vitamin D). CTA018 was designed by Prof. Gary H. Posner and is protected under patents and patent applications exclusively licensed to Cytochroma Inc. from the Johns Hopkins University.

Psoriasis is a common immune-mediated chronic skin disease often characterized by red, scaly plaques that itch, burn, sting, and bleed easily. It afflicts approximately 125 million people worldwide; more than 70% of patients have the mild to moderate form. Psoriasis is found in all age groups and often seriously compromises the quality of life of those affected. Current methods of treatment are either inconvenient, show poor remission rates, and/or have serious side effects. Cytochroma has recognized that there is a need for improved therapies.