LONDON (ShareCast) - Speciality pharmaceuticals firm Allergy Therapeutics has received the approval from the Canadian health regulators to submit a full clinical trial application for a new study of its hay fever vaccine.

Following on from successful discussions held with the US Food and Drug Administration previously, Health Canada’s decision will now enable Allergy Therapeutics to start planning a G304 clinical efficacy study for Pollinex Quattro Grass MATA MPL, which will involve two clinical sites in the US as well as one in Canada.

The study, which will involve over 600 patients, will expose them to grass pollen in environmental exposure chambers before and after treatment with the vaccine, compared with a placebo. They will then be evaluated for 12 months post treatment to determine the long-term efficacy of the product.

Chief Executive Manuel Llobet said he is “pleased with the progress we have made with the regulatory authorities in the US and Canada”.

He said that recent positive developments in US allergy regulation support the group’s confidence that North America will emerge as a “valuable market” for registered allergy vaccines.

“We continue to explore our strategic options for the development and commercialisation of Pollinex Quattro in this territory,” he said.

The stock was 6.7% higher at 14p by 13:26 on Thursday.

BC

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