Research Update

Allergy Therapeutics PLC 02 April 2007 2 April 2007 Allergy Therapeutics plc ("Allergy Therapeutics" or "the Company") Commencement of Dosing in Pollinex(R) Quattro Phase III Ragweed Trial Now running the two largest international allergy vaccine trials ever conducted Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company focused on allergy vaccination, announces that it has commenced dosing in patients in its pivotal Phase III ragweed allergy trial (R301). This trial will be undertaken at more than 65 centres in the United States and Canada. Pollinex Quattro is an ultra-short course vaccine requiring only four shots over three weeks and incorporates the TLR4 agonist adjuvant MPL(R). In contrast, existing vaccine treatments typically require between 16 and 50 injections taken under specialist supervision prior to the start of the hayfever season. Pollinex Quattro therefore has the potential to transform allergy treatment by providing a safe, effective and highly convenient method of vaccination. The Company has three programmes of Pollinex Quattro allergy vaccines in clinical development: Grass, Tree and Ragweed. The primary objective of this double blind, randomised trial is to compare the efficacy and safety of Pollinex Quattro Ragweed versus placebo. The trial design and endpoints have been approved by regulatory bodies, including the Food and Drug Administration in the United States. This single pivotal trial, if successful, is suitable for registration. A Biologics License Application is planned for the second half of 2008. This phase III trial follows a similar study with Pollinex Quattro Grass, which commenced earlier this year. The Pollinex Quattro Ragweed study, positions the Company to launch in 2009 the first two approved allergy vaccines in the United States. Evidence of the safety and efficacy of Pollinex Quattro has been established through earlier clinical trials in Europe. Furthermore, substantial exposure data in more than 87,000 patients is available from the named patient programme in Europe. The market opportunity is considerable with the American Academy of Allergy, Asthma and Immunology estimating that 33 million allergy injections a year are given in the United States. Allergic rhinitis (hay fever) is a large and growing problem. Prevalence estimates vary on a country by country basis but range from 14-29% of the total population*. Worldwide over 150 million people are estimated to suffer from allergic rhinitis and the prevalence is increasing *. There is a substantial unmet medical need in a market currently worth an estimated US$12 billion per annum. * Decision Resources Allergic Rhinitis June 2005 Keith Carter, Chief Executive of Allergy Therapeutics, said: "Today's announcement represents another step towards Allergy Therapeutics' aim of developing patient friendly, highly-effective treatments for hay fever sufferers worldwide. For a company of our size to be conducting the two largest allergy vaccine trials ever undertaken is a significant achievement." Dr Harold Kaiser, Clinical Professor of Medicine at the University of Minnesota Medical School, R301 Co-ordinating Principal Investigator, who enrolled the first patient, said: "I am pleased to be involved with this pivotal study with this innovative allergy immunotherapy product. The benefit gained by the inclusion of the adjuvant MPL - an alternative very short course of immunotherapy seems to me to offer the potential of a convenient treatment option for busy physicians and their patients." For further information Allergy Therapeutics +44 (0) 1903 844 722 Keith Carter, Chief Executive Financial Dynamics +44 (0) 207 831 3113 David Yates Ben Brewerton About Pollinex Quattro There are three programmes of subcutaneous immunotherapy in clinical development; Pollinex Quattro Grass, Pollinex Quattro Ragweed & Pollinex Quattro Tree, all of which are based on proprietary technologies. Collectively these form the "Caution: Allergen" programme. Pollinex Quattro Ragweed is currently under review by Health Canada. In addition, an oral vaccine development is completing its first phase II study. Pollinex Quattro vaccines contain three distinct technologies which act synergistically. Natural allergens are chemically modified to improve safety and allow for delivery of higher doses. These are combined with a depot technology to provide prolonged desensitization and further improved tolerability. Finally, the immune response is specifically enhanced and directed by an adjuvant, monophosphoryl lipid A (MPL). MPL is a Toll-Like 4 Receptor (TLR4) agonist and has been extensively tested in Pollinex Quattro and other late stage and registered vaccines including GlaxoSmithKline's Fendrix(R) and Cervarix(R) About Allergy Therapeutics plc Allergy Therapeutics plc is a UK AIM-listed specialty pharmaceutical company focused on allergy vaccination. It has a profitable core business achieving sales of allergy vaccines of over £24m in Germany, Italy, Spain and other EU markets through its own sales and marketing infrastructure. This information is provided by RNS The company news service from the London Stock Exchange
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