Allergy Thera. Regulatory News (AGY)

24 Mar 2006 07:02

Allergy Therapeutics PLC24 March 2006 Allergy Therapeutics plc Positive outcome of pivotal Pollinex(R) Quattro Ragweed study - R204 Allergy Therapeutics plc, the specialist pharmaceutical company focused on allergy vaccination, today announces that it has achieved a positive outcome for its key clinical efficacy and safety study R204. The R204 study is a crucial part of the company's development of their ultra short course allergy vaccines, Pollinex Quattro. These four shot products are based on MPL(R), the company's innovative TLR4-agonist which acts as an efficient allergy vaccine adjuvant. Pollinex Quattro Ragweed is designed to treat patients allergic to ragweed pollen. It is estimated that more than 30 million people in North America suffer from allergies to ragweed. The Pollinex Quattro allergy vaccines, which require only four injections per year, have the potential to transform allergy treatment, by providing a convenient, safe, effective and potentially curative method of vaccination. The positive R204 study results mark an important step in the development ofPollinex Quattro for ragweed allergy. In addition, the R204 outcome: • supports the Company's application for registration in Canada planned for the middle of 2006; • is a key element in "End of Phase II" discussions with the FDA and other authorities prior to initiating Phase III; • contributes to the data on safety and efficacy of the company's other ultra short course Pollinex Quattro vaccines in Grass and Tree, which are also in development. The R204 study was conducted in an Environmental Exposure Chamber (EEC). A groupof 177 ragweed sensitive patients were exposed to controlled quantities ofragweed pollen to simulate a heavy pollen day and their reactions before andafter treatment were compared. The initial results of this study demonstratethat Pollinex Quattro Ragweed was well tolerated and significantly reducedclinical symptoms compared with placebo. The Pollinex Quattro treatment grouptotal symptom score had fallen to 9.1 from a baseline of 15.7. The 'primaryendpoint' of the study, this change from baseline in the active treatment group,was statistically significant (p