VRI launches allergy Phase II trials

VRI BioMedical has started two Phase II clinical trials in Western Australia and the UK to evaluate the use of its probiotic bacteria for prevention and treatment of allergic disease.

"We're looking to develop a pharmaceutical grade probiotic to down regulate the immune response," said company secretary John Frame.

Both trials will use VRI's probiotic Lactobacillus acidophilus strain, which has previously been shown in animal studies to have a modulating effect on allergies, according to Prof Patricia Conway, general manager of the company's biopharmaceutical program.

Conway said that the concept of probiotics began some years ago. Research has since demonstrated that probiotic bacteria have effects on the immune system, possibly by up-regulating some cytokines, and down regulating others, particularly those involved in inflammatory responses.

But not all Lactobacillus strains have this immunomodulatory effect, Conway said. In fact, some of them are better than others.

"Basically we start with an animal model and screen a range of probiotic strains to find ones suitable for the particular condition, and then move into human clinical trials," she explained.

One of the clinical trials, to be performed at Princess Margaret Hospital for Children in Western Australia by Prof Susan Prescott, will investigate the effect of the probiotic on prevention of the development of allergic disease in newborns.

According to Conway, the study will follow the infants for about two years, and will compare the effect of the probiotic in breast-fed and formula-fed infants to groups receiving a placebo.

The second clinical study will be performed at Southampton Hospital in the UK, under Prof Peter Howarth. This study will involve 150 adults, who will receive the probiotic in combination with orally delivered desensitisation therapy for house dust mite allergens.

Both studies will be blinded, said Conway. She noted that for probiotics this was an essential requirement for proper evaluation of results.

Frame said the global allergy market was a fairly significant one, with antihistamines sales worth $US5.5 billion and growing.

VRI also announced that Peter French, co-founder and non-executive director of cord-blood storage bank Cryosite, was joining the company as the chief operating officer. He will stay in Sydney, near the company's research facilities in Sydney and Newcastle.

VRI chairman Leon Ivory said French would be responsible for coordinating the scientific operations of the company, including clinical trials and product development.