Written by Nick Evans Tuesday, 08 December 2009 14:58
UNLISTED WA biotech Ondek has launched a Phase 1 trial of the company’s novel vaccine technology, planning to trial its oral delivery technology on 36 healthy adult volunteers over the next 12 months.
The company, of which Nobel laureate Dr Barry Marshall is scientific director, is intending to use genetically modified helicobacter pylori bacterium to vaccinate against common diseases.
According to the company, its platform technology allows the modification of H. pylori so the bacterium expresses antigens on its surface, mimicking the structure of common diseases and provoking an immune response – in the same way a traditional vaccine would work.
It was the discovery that helicobacter causes stomach ulcers that won Marshall, along with Dr Robin Warren, the 2005 Nobel Prize for Physiology or Medicine.
Helicobacter buries itself into the mucoid lining of the stomach, and Ondek believes that characteristic is what will allow it to stimulate an immune response.
The newly launched Phase 1 trial, being conducted at Sir Charles Gairdner Hospital in Western Australia, will trial several unmodified strains of helicobacter to test the safety of the vaccine delivery technique and to measure immune response in patients.
Marshall said the company had picked several strains of helicobacter that it believes have a strong safety profile, having been collected from people who have carried that bacterium for long periods without noticeable ill effect.
The Phase 1 study will compare the safety of these strains, and also collect information on which of them produces the strongest immune response.
That strain will then likely be modified to express influenza antigens and will enter further clinical studies to test its efficacy as a vaccine proper.
The company expects the trial to close in the second half of next year, with data likely to be available in around 18 months, according to Marshall.
Ondek has previously completed a small Phase 1 trial of a single helicobacter strain. Results from that trial, which included only five patients, are due to be published in the second quarter of 2010.
Ondek is still to close the $10 million capital raising the company launched in July, however.
Chief executive Peter Hammond said the company had reached agreement with a number of investors, but was still finalising discussions with several potential cornerstone investors.
Hammond said those discussions were likely to be finalised early next year, though Ondek still has around 12 months operating cash available.
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