Business
Health Canada approves submission of CTA
Health Canada approves submission of CTA.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 3824A Allergy Therapeutics PLC 19 February 2014 \n \n\n19 February 2014\n \n \nAllergy Therapeutics plc\n(\"Allergy Therapeutics\" or the \"Company\")\n \n \nHealth Canada approves submission of CTA to progress ultra-short course Pollinex Quattro Grass efficacy study \n \n \nAllergy Therapeutics, the fully integrated specialty pharmaceutical company, announces that the Canadian Health Authority, Health Canada, has approved the Company's proposal 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 18th February 2014.\n \nThe meeting builds on the successful discussions held with the 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.\n \nThe 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. \n \nPatients 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. \n \nThe 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 27th January 2014. \n \nManuel Llobet, Chief Executive Officer of Allergy Therapeutics, comm...