Psoriasis trial enters final stage

Nov 4 2004

Solbec Pharmaceuticals Ltd today announced the successful completion of the first two stages of the Phase I clinical trial of its lead compound, CoramsineTM (SBP002), for the treatment of psoriasis. The company has entered the third and final stage of the clinical trial which involves the testing of Coramsine on patients with psoriasis.

In the first two stages of the trial, Coramsine cream was applied to the skin of healthy individuals who were monitored for unwanted side-effects and reactions. None was observed.

"In this final stage of the Phase I trial, Coramsine will be compared with a commonly used psoriasis treatment in a double-blind, placebo-controlled trial, the gold standard of clinical testing. Importantly for Solbec, the trial will monitor how well the psoriasis responds to treatment as well as any unwanted outcomes," said Stephen Carter, CEO of Solbec.

The objective of the trial is to establish that Coramsine can be used safely by psoriasis patients without significant side-effects, and therefore warrants progression to larger Phase II studies. Solbec expects completion of the trial early during 2005.

This is the first controlled testing of Coramsine cream in the treatment of psoriasis, a common, non-infectious, chronic skin disease for which there is no cure. The trial is being conducted for Solbec by CMAX, a division of IDT Australia Ltd.

CMAX is located in the Royal Adelaide Hospital and was chosen to conduct this important trial because of its track record in managing clinical trials and specific experience in psoriasis.

Psoriasis affects between three and five per cent of the population and shows a wide spectrum of severity. It is uncomfortable at best, may can reach a severity that has a major impact on quality of life, and occasionally can result in death. While the exact cause of psoriasis is unknown, the prominent red scaly patches are thought to be triggered by a defect in the immune system that leads to excessive growth and division of skin cells. The patches of skin where this occurs are often itchy and constantly shed skin cells.

Coramsine contains two compounds extracted from a plant known as the Devil's Apple and is undergoing parallel development for the treatment of psoriasis and cancers such as mesothelioma and melanoma. It is presumed to act on psoriasis skin lesions by inhibiting a cytokine, interleukin-6, associated with inflammation. Coramsine is one of several compounds now in development around the world which is thought to work in this way.

Solbec has identified the need for a product to treat psoriasis successfully that is more active than other creams in use today and which overcomes the need for delivery by injection or is not linked to potentially serious side-effects.

The CMAX clinical trial has been designed with the intention to demonstrate that Coramsine cream can be given safely and to give an early indication of efficacy. In the first two stages of the trial, six healthy volunteers applied Coramsine cream for periods up to 7 days. In the double blind third stage, 10 psoriasis sufferers will each apply Coramsine cream, calcipotriol cream, and a placebo cream to different lesions for a period of 56 days. The lesions will be monitored at various times during the trial using the Local Plaque Severity Index and by physician assessment.

Solbec Pharmaceuticals Ltd identifies naturally-occurring compounds with potential in the development of better therapies for debilitating conditions and life-threatening diseases. The company is currently progressing its key project, Coramsine, through Phase I/IIA clinical trials for the treatment of mesothelioma and malignant melanoma, and as a topical treatment for psoriasis. Solbec's two proprietary ingredients in Coramsine were isolated from the fruit of a weed known as the Devil's Apple (Solanum linnaeanum). They show activity against some cancers and cause potentially therapeutic changes to the immune system. In addition to human health, Coramsine has potential application in the areas of animal health and diagnostics. Solbec's business strategy is to partner or out-license Coramsine for the final stages of pre-commercial development and marketing.