Genesis pins hopes on skin vaccine trial

New Zealand genomics and drug-development biotech Genesis Research and Development Corporation (NZSX/ASX:GEN) is keenly awaiting the unblinding of its Phase II clinical trial results for its AVAC vaccine for atopical dermatitis, after its UK partner's experimental vaccine failed to exhibit any benefit in children with eczema..

Auckland-based Genesis formed a strategic partnership with London biopharma SR Pharma (LSE:SPA) after the two companies learned they were developing rival vaccines for atopical dermatitis (childhood eczema).

Genesis CEO Dr Jim Watson said researchers have finished recruiting the 250 eczema patients, aged 5 to 16, into its trial in Auckland, but no results will be available until Christmas or soon after.

SR Pharma pulled the plug on further trials of its candidate vaccine, SRP299, after clinical studies showed it produced no significant benefit in volunteers with moderate to severe childhood eczema.

Genesis' experimental vaccine, AVAC, has already been shown to produce an obvious therapeutic benefit during a Phase I trial to test its safety and tolerability in eczema patients.

Watson said the failure of SR Pharma's candidate vaccine vindicated the decision to have "two shots on goal" -- to run parallel clinical trials and share any revenues from the more successful of the two vaccines.

"We think the strategy was right -- companies have to reduce their commercial risks and the costs of doing clinical trials," he told Australian Biotechnology News.

The SRP vaccine consisted of a suspension of heat-killed Mycobacterium vaccae, a microbe that is closely related to the agent that gives rise to bovine tuberculosis; Genesis' AVAC vaccine employs a small component of the cell wall from the same microbe.

Both vaccines were developed to remedy a T-cell imbalance that underlies the allergic disorder known as atopical dermatitis -- patients with childhood eczema are also at increased risk of two other atopic disorders, asthma and allergic rhinitis (hay fever).

The AVAC product is aimed at enhancing the TH1 response in helper-inducer lymphocytes, which promotes a stronger cytotoxic T-cell reaction, while suppressing the TH2 response, which stimulates antibody production by B cells.

The prevalence of the three atopic diseases in industrialised nations has more than doubled in the past 30 years, a trend attributed to the marked reduction in the incidence of once-common infectious diseases of childhood.