Allergy Therapeutics, a fully integrated specialty pharmaceutical company focused on allergy vaccination, has received approval from the Canadian Health Authority, Health Canada, to submit a full Clinical Trial Application (CTA) for a new clinical efficacy study (G304) for Pollinex Quattro Grass MATA MPL (0.5ml). Health Canada reviewed the proposal and all supporting data at a meeting with the Company on February 18, 2014.
The meeting builds on the successful discussions held with the US FDA, which 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 similarly had a hold on CTAs involving MPL. These decisions enable the Company to plan the start of the G304 study, which will involve two clinical sites in the USA as well as one in Canada.
The study, involving over 600 patients, will use multiple Environmental Exposure Chambers (EECs), 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 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.
The safety and efficacy advantages of the addition of MPL to the MATA products, previously seen in Allergy Therapeutics' Pollinex QuattroRagweed MATA MPL (0.5 ml), will be further determined during the G304 study. The full results of the ragweed clinical trial were recently published in the January print edition of The Journal of Allergy and Clinical Immunology1 (JACI) and summarised in the Company press release dated January 27, 2014.
Manuel Llobet, chief executive officer of Allergy Therapeutics, commented: “I am pleased with the progress we have made with the regulatory authorities in the US and Canada. The planned Environmental Exposure Chamber study for grass has been designed to build on the success of the Ragweed study, published in The Journal of Allergy and Clinical Immunology in January this year. 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."
"In Europe we continue to grow the market share of our allergy products and I look forward to reporting fully on our market developments in the forthcoming Interim announcement."
The Pollinex Quattro Grass MATA MPL (0.5ml) offers the full advantages of the Pollinex Quattro product range, including the MPL adjuvant, enabling an ultra-short course of just four injections in as little as three weeks. The Grass MATA (0.5ml) will allow a determination of the size of the benefit of including the MPL in the Grass vaccines.