Allergy Thera. Regulatory News (AGY)

7 Dec 2006 07:02

Allergy Therapeutics PLC07 December 2006 Thursday 7 December 2006 Allergy Therapeutics plc Promising data from oral allergy vaccine study Preliminary results show potential for a rapid action, injection-free allergy treatment Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical companyfocussed on allergy vaccination, announces that it has received promisinginitial data in its Phase IIa study of an oral (sub-lingual) grass allergyvaccine. This study gives confidence that Allergy Therapeutics can develop aneffective, rapid-onset, orally delivered allergy vaccine. Allergy Therapeutics' new generation of allergy vaccines use MPL(R), aninnovative TLR4-agonist which boosts and accelerates the immune response. Thisstudy is the first ever examination of oral delivery of MPL in man. MPL iscurrently used in injectable form by GlaxoSmithKline within their range ofanti-infective vaccine products. Preliminary results from the first 3 active treatment groups show: • The vaccine was safe and well tolerated with minimal local side effects and no patients withdrawn or discontinued. • The vaccine showed systemic effects and was immunologically active. A significant increase against placebo in grass specific antibodies was seen after 8 weeks of once a day administration in the two MPL-containing treatment groups. • The vaccine improved symptoms. These immunological changes were mirrored by clinical improvements (as measured by nasal challenge) in the MPL-containing groups. The full analysis and results from the final group (high dose MPL plus high doseallergen) will be available in the first quarter of 2007. What does it mean for allergy sufferers? Allergic rhinitis (or hay fever) is a large and growing problem. Prevalenceestimates vary on a country by country basis but range from 14-29% of the totalpopulation (1). Worldwide over 150 million people are estimated to suffer fromallergic rhinitis1 and the prevalence is increasing. Allergy Therapeutics is already in the latter stages of seeking regulatoryapproval for a ultra-short course, four injection MPL-based treatment, Pollinex(R) Quattro. This therapeutic vaccine has been used in a number of Europeancountries on a named patient basis and over 79,000 patients have been safelytreated. The development of a convenient, effective, short course, oral vaccine wouldhave significant implications for allergy therapy and redefine the market forallergy products. There is a substantial unmet medical need and substantialcosts to society including US$12 billion of spending on pharmaceuticals. Keith Carter, Chief Executive of Allergy Therapeutics, said: "Allergy Therapeutics' objective is to transform allergy treatment. Ourtechnology is able to increase the effect of allergy vaccines by priming theimmune system. This will enable us, following approval, to reduce the currentregime in the United States of 40 injections to just 4 injections. Now it lookslike we are able to produce a similar effect in oral vaccines. These resultsprovide the first indication that we have the technology to deliver a painless,patient friendly, injection-free, potentially curative allergy treatment. "We firmly believe that both our oral and subcutaneous vaccine formulations arepotentially "best in class" and promise life-improving benefits for the millionsof sufferers world-wide." Linda Cox, MD, FAAAAI, Chair of the AAAAI Immunotherapy and Allergy DiagnosticsCommittee, said: "Allergy sufferers need new treatments which deliver better symptom control andare potentially curative. Allergy Therapeutics seems to have been able todemonstrate significant enhancement of the speed and convenience of theproducts, both injected and now oral. This may offer physicians additionaltreatment options and patients a vastly improved quality of life". For further information Allergy Therapeutics +44 (0) 1903 844 722Keith Carter, Chief Executive Financial Dynamics +44 (0) 207 831 3113David YatesBen Brewerton (1) Decision Resources Allergic Rhinitis June 2005 Study GSL103 The study, GSL103, was the first ever conducted in man using orally delivered(sub-lingual) allergen in combination with MPL. MPL is an innovativeTLR4-agonist which boosts and accelerates the immune response. The initial partof the study involved three groups of 20 grass allergic patients treated withextracts of grass pollen either alone or in combination with different doses ofMPL compared to placebo. The patients' symptoms were assessed by nasal challengein addition to sampling to measure induction of grass specific antibodies. This information is provided by RNS The company news service from the London Stock Exchange