Allergy Thera. Regulatory News (AGY)

23 Jan 2007 07:01

Allergy Therapeutics PLC23 January 2007 23 January 2007 Allergy Therapeutics plc ("Allergy Therapeutics" or "the Company") Commencement of Pollinex(R) Quattro Grass Dosing First ever global allergy vaccine trial Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical companyfocused on allergy vaccination, announces that it has dosed the first patient inits pivotal Phase III grass allergy trial. This international trial will beundertaken at approximately 96 centres in 4 countries and will involve enrolmentof over 1000 patients. The majority of patients will be recruited in the UnitedStates. 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 of Pollinex Quattro Grass versus placebo. The trial design and endpoints have been approved by regulatory bodies includingthe Food and Drug Administration in the United States. This single trial, ifsuccessful, is suitable for registration in both the United States and Europe,with a Biologics License Application ("BLA") planned for the first half of 2008. A similar Phase III trial is planned for Allergy Therapeutics' Pollinex QuattroRagweed allergy vaccine in the 2007 ragweed pollen season. 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 150m people areestimated 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. It is a significant trial, involving a large number ofpatients and, as the pollen season window is relatively short, we are alreadyactively recruiting patients to participate in the study. "This is the first registration trial for an allergy vaccine ever undertaken inthe United States, which is a significant achievement for a company of our size.Achieving this milestone underlines the quality of our earlier work and thesubstantial safety data which underpins the entire Pollinex Quattro pipeline." Dr Lawrence DuBuske, Consultant in Allergy at Brigham and Women's Hospital ofHarvard Medical School, said: "We are very excited to be a participating site in what we hope to be a landmarktrial by Allergy Therapeutics. The trial could potentially demonstrate thatToll Like Receptor activation together with modified allergen administration canprovide both rapid and safe symptom relief for patients with seasonal grassallergy. This large trial harnesses recent advances in our understanding of themechanisms of modulation of immune responses and its success could provide thebasis for the first new allergen-specific therapy for allergic rhinitis in theUnited States. "The requirement for only four pre-seasonal injections to achieve benefit fromthis treatment could lead to a substantial increase in the number of allergysufferers who will consider allergen specific immunotherapy as a desirabletreatment option." 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