Genesis to launch Phase II eczema trial in UK

Auckland biopharma Genesis Research and Development Corporation (NSX/ASX:GEN) is to begin a Phase II clinical trial of its AVAC therapy for paediatric atopic dermatitis, or childhood eczema.

The randomised, placebo-controlled trial will run in parallel with the current UK Phase II trial by Genesis' UK partner SR Pharma of its own experimental eczema remedy, SRP299.

Both candidate therapies employ antigens from the microbe that causes bovine tuberculosis, Mycobacterium vaccae. Genesis' lead compound uses a single, pure antigen, where SR Pharma's SRP99 is a heat-killed suspension of the whole bacterium.

The New Zealand trial will randomly assign 120 children aged 5 to 16 who suffer from eczema, to two groups who will receive three injections of AVAC or a placebo at intervals of two weeks.

Genesis's head of corporate services, Stephen Hall, said AVAC was a modified form of PVAC, which produced visible improvements in skin health in some of the children in a Phase I clinical trial, even though that trial was only to test how eczema patients tolerated the treatment.

Hall said both the Genesis and SR Pharma candidate therapeutics worked by rebalancing an abnormal T1/T2 T-cell response found in individuals who are susceptible to a cluster of so-called atopic disorders including eczema, asthma and allergic rhinitis - hay fever.

The incidence of such disorders has tripled in industrialised nations the past 30 years; epidemiological studies have linked the increase to a reduction in exposure to common infectious diseases in childhood, due to the modern consumer obsession with household-hygiene products.

In a statement, Genesis said between 10 and 20 per cent of children suffered from atopic dermatitis in childhood. There are an estimated 60 million eczema sufferers worldwide, so the market for an effective treatment is potentially huge.

Hall said that rather than clash head-on in the international market, Genesis and SR Pharma clarified their IP claims and entered a partnership in which both companies, after independently evaluating their proprietary treatments, would jointly develop and commercialise the most effective of the two.

Genesis has already run a Phase I trial of its therapeutic in asthmatic children, to test its safety, but has decided to give priority to development as an eczema therapy.

Hall said results from the Genesis eczema trial should be available in December 2004.