Business
Research Update
Research Update.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n RNS Number : 9363D Allergy Therapeutics PLC 22 September 2008 \n \nMonday 22 September 2008\n\nAllergy Therapeutics plc\n(\"Allergy Therapeutics\" or \"the Company\")\n\nPivotal Phase III Pollinex® Quattro Ragweed study meets primary efficacy endpoint\n\nFirst ever large scale allergy vaccine study showing proof of \nsafety and efficacy in Ragweed patients\n\nFurther confirmation of Pollinex Quattro safety and efficacy following recently announced results from Pollinex Quattro Grass study\n\nAllergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company focused on allergy vaccination, today announces positive results from its Pollinex Quattro Ragweed Phase III study, R301, the second largest controlled allergy vaccine study ever conducted. The study met its primary efficacy endpoint and demonstrated that Pollinex Quattro Ragweed has statistically significant clinical benefits over placebo. On 14 May 2008, Allergy Therapeutics announced that its earlier study, Pollinex Quattro Grass (\"G301\"), had met its primary efficacy endpoint in what is still the largest allergy vaccine study ever conducted. \n\nAllergy Therapeutics intends to use the results of the ragweed study to support a Marketing Approval Application in Canada with a submission planned for 2009. Allergy Therapeutics believes that Pollinex Quattro has the potential to transform the treatment of allergy, changing the lives of patients and providing an important new tool for the specialists who treat them. The worldwide market for allergy treatments is estimated to be in excess of $10 billion.\n\nStudy R301 examined the safety and efficacy of Pollinex Quattro Ragweed in the treatment of seasonal allergic rhino-conjunctivitis (\"SAR\") caused by ragweed pollen. R301 was a double-blind, placebo-controlled study comparing the symptom/medication score of patients given four injections of Pollinex Quattro to those patients receiving placebo. The trial enrolled 993 patients at up to 85 centres in the United States and Canada. Due to a clinical hold placed on the study by the Food and Drug Administration in the United States related to an adverse event in G301, only 381 patients received all four injections, nevertheless, the study met its primary endpoint with Pollinex Quattro Ragweed demonst...