Allergy Thera. Regulatory News (AGY)

2 Apr 2007 07:02

Allergy Therapeutics PLC02 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 companyfocused on allergy vaccination, announces that it has commenced dosing inpatients in its pivotal Phase III ragweed allergy trial (R301). This trial willbe undertaken at more than 65 centres in the United States and Canada. Pollinex Quattro is an ultra-short course vaccine requiring only four shots overthree weeks and incorporates the TLR4 agonist adjuvant MPL(R). In contrast,existing vaccine treatments typically require between 16 and 50 injections takenunder specialist supervision prior to the start of the hayfever season. PollinexQuattro therefore has the potential to transform allergy treatment by providinga safe, effective and highly convenient method of vaccination. The Company hasthree 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 theefficacy and safety of Pollinex Quattro Ragweed versus placebo. The trialdesign and endpoints have been approved by regulatory bodies, including the Foodand Drug Administration in the United States. This single pivotal trial, ifsuccessful, is suitable for registration. A Biologics License Application isplanned for the second half of 2008. This phase III trial follows a similar study with Pollinex Quattro Grass, whichcommenced earlier this year. The Pollinex Quattro Ragweed study, positions theCompany to launch in 2009 the first two approved allergy vaccines in the UnitedStates. Evidence of the safety and efficacy of Pollinex Quattro has been establishedthrough earlier clinical trials in Europe. Furthermore, substantial exposuredata in more than 87,000 patients is available from the named patient programmein Europe. The market opportunity is considerable with the American Academy of Allergy,Asthma and Immunology estimating that 33 million allergy injections a year aregiven in the United States. Allergic rhinitis (hay fever) is a large andgrowing problem. Prevalence estimates vary on a country by country basis butrange from 14-29% of the total population*. Worldwide over 150 million peopleare estimated to suffer from allergic rhinitis and the prevalence is increasing*. There is a substantial unmet medical need in a market currently worth anestimated 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' aimof developing patient friendly, highly-effective treatments for hay feversufferers worldwide. For a company of our size to be conducting the two largestallergy vaccine trials ever undertaken is a significant achievement." Dr Harold Kaiser, Clinical Professor of Medicine at the University of MinnesotaMedical School, R301 Co-ordinating Principal Investigator, who enrolled thefirst patient, said: "I am pleased to be involved with this pivotal study with this innovativeallergy immunotherapy product. The benefit gained by the inclusion of theadjuvant MPL - an alternative very short course of immunotherapy seems to me tooffer the potential of a convenient treatment option for busy physicians andtheir patients." For further information Allergy Therapeutics +44 (0) 1903 844 722Keith Carter, Chief Executive Financial Dynamics +44 (0) 207 831 3113David YatesBen Brewerton About Pollinex Quattro There are three programmes of subcutaneous immunotherapy in clinicaldevelopment; Pollinex Quattro Grass, Pollinex Quattro Ragweed & Pollinex QuattroTree, all of which are based on proprietary technologies. Collectively theseform the "Caution: Allergen" programme. Pollinex Quattro Ragweed is currentlyunder review by Health Canada. In addition, an oral vaccine development iscompleting its first phase II study. Pollinex Quattro vaccines contain three distinct technologies which actsynergistically. Natural allergens are chemically modified to improve safety andallow for delivery of higher doses. These are combined with a depot technologyto 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 andhas been extensively tested in Pollinex Quattro and other late stage andregistered vaccines including GlaxoSmithKline's Fendrix(R) and Cervarix(R) About Allergy Therapeutics plc Allergy Therapeutics plc is a UK AIM-listed specialty pharmaceutical companyfocused on allergy vaccination. It has a profitable core business achievingsales of allergy vaccines of over £24m in Germany, Italy, Spain and other EUmarkets through its own sales and marketing infrastructure. This information is provided by RNS The company news service from the London Stock Exchange