19th Feb 2014 09:12
LONDON (Alliance News) - Allergy Therapeutics PLC said Wednesday that the Canadian health authority has approved its proposal to submit a full clinical trial application for an efficacy study for Pollinex Quattro Grass MATA MPL (0.5ml).
The speciality pharma firm said its proposal for a new clinical efficacy study (G304) for the hay fever treatment was approved at a company meeting with Health Canada February 18 2014.
Allergy Therapeutics said the meeting builds on successful FDA discussions, which have resulted in the lifting of the clinical hold on the Company's clinical studies using vaccines containing the adjuvant monophosphoryl lipid A (MPL) in August 2012; Health Canada initiated a similar hold on CTAs involving MPL. These decisions will enable the firm to plan the start of the G304 study, which will involve two clinical sites in the USA as well as one in Canada, it said.
The study, involving over 600 patients, will use multiple Environmental Exposure Chambers, allowing for controlled allergen exposure, to study the response to treatment with the new Pollinex Quattro Grass MATA MPL (0.5ml) compared to Grass MATA (0.5 ml) and a placebo. Patients will be exposed to grass pollen in the EECs before treatment and then after treatment, with the ultra-short course of four subcutaneous injections. An evaluation of long term efficacy, 12 months post treatment, in patients enrolled for the G304 study will also be made in the EECs
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics said, "The recent positive developments in the US allergy regulatory environment further underscore our 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."
Shares in Allergy Therapeutics were trading up 6.61% at 13.9925 pence per share Wednesday morning.
By Alice Attwood; [email protected]; @AliceAtAlliance
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