Directorate change and update

Allergy Therapeutics PLC 22 November 2005 Board Change and clinical update Allergy Therapeutics ('ATp') today announces the following update on the progress of its extensive clinical development programme: * Recruitment into the pivotal Ragweed allergy vaccine trial, R204 (see note 1), has been completed with 228 patients randomised into the study. Preliminary results are expected during the first quarter of 2006. * The FDA has opened an IND (Investigational New Drug) file for ATp's Ragweed Allergy Vaccine. * Preliminary results show the phase I studies (G101, T101 and R101) (see Note 2) have concluded, demonstrating greatly reduced allergenicity of ATp's modified allergen containing products as compared with natural, unmodified allergens. Commenting on these clinical developments, Dr. Tom Holdich (R&D Director) said: "The completion of recruitment for R204 represents a major milestone in Allergy Therapeutics' development activities. Our first pivotal study is now moving to the final clinical phase. The opening of an IND to cover Ragweed vaccines is also an important achievement. We now have 3 INDs open (the other 2 for grass and tree) and a clear path to conducting the clinical trials in the USA required for registration in this, the world's largest market for treatments for Allergic Rhinitis. Finally, it is rewarding to see the 101 studies confirming the success of our modification process in reducing the allergenicity of the products and so the improved safety as compared with native allergen". ATp also announces the resignation from the board of Andrew Turnbull, Director of Business Development and Supply Operations. Andrew will be replaced by Ray Keeling as Head of Supply Operations and Manjit Rahelu as Head of Business Development. Neither of these new positions involves a seat on the board. Brief biographies of Ray and Manjit are set out below(Notes 3 and 4). CEO Keith Carter said "These are very positive developments on our pipeline; the Ragweed 204 study is our first major pivotal efficacy/safety study and as such its progress is key. We are sorry that Andrew has made a decision to return to his native New Zealand. His contribution to the growth of Allergy Therapeutics has been enormous. We have however been very fortunate in being able to replace him with two excellent specialists in the fields of Supply and Business Development." For further information: Allergy Therapeutics 01903 844720 Keith Carter, Chief Executive Bell Pottinger 020 7861 3232 Dan de Belder / Emma Charlton Notes: 1) About R 204 A phase II clinical study in Canada using an advanced formulation of a ragweed allergy vaccine. The study is 'pivotal' for Canada and would form the basis of a New Drug Submission dossier without the need for further studies. Ragweed is a large yellow weed producing pollen which is the primary cause of hay fever symptoms in both Canada and the United States, where as many as 40 million of the total population are affected. The design of the trial is advanced, and utilises an environmental exposure chamber (EEC). Patients are exposed to controlled quantities of ragweed pollen, providing a simulation of a heavy pollen day. The treated patients will be monitored for any resulting symptoms and these will be compared with patients injected with a placebo vaccine. This innovative approach is felt to give far greater accuracy than older measures of activity such as skin prick testing. The new ragweed vaccine incorporates MPL(R), a TLR-4 agonist which acts as an efficient allergy vaccine adjuvant. MPL(R) is incorporated in our existing Pollinex Quattro pollen vaccine, currently enjoying success as a NPP (named patient product) in Europe owing to its simple and fast 4-shot, 3-week course. Pollinex Quattro has been shown to be both efficacious and safe in double-blind placebo-controlled studies, and these results have been endorsed in post-marketing surveillance studies, including those for children and adolescents . Over 115,000 treatment sets have been sold in Europe to date as NPP, mainly for allergic sensitivities to grass and tree pollens. 2) About the 101 studies ATp's modern allergy vaccines are composed of 3 components i) Allergoids - allergens modified to reduce their allergenicity whilst retaining their immunogenicity, to allow safer more rapid up-dosing, ii) tyrosine - a depot designed to release the vaccine gradually at the injection site, another safety feature, and iii) MPL(R) - ATp's patented vaccine adjuvant incorporated to improve the efficacy of the vaccines thereby creating an efficacious treatment with greatly reduced number of injections. The purpose of the three Phase I studies was to illustrate that the levels of 'residual allergenicity' after modification in ATp's allergoid products were very low. The experiments were conducted by titrated Skin Prick Testing comparing wheal size provoked by progressively attenuated native allergen solution with solutions containing 1. allergoids alone, 2. allergoids plus tyrosine (MATA or Pollinex), and 3. allergoids plus tyrosine plus MPL(R) (Pollinex Quattro). The results are as follows (expressed as % equivalent of native allergen to produce a wheal size of equal area to that produced by the 100% concentration of the modified product) Modified Allergen MATA Pollinex Quattro Grass 2.00% 0.25% 0.30% Tree 4.00% 0.36% 0.33% Ragweed 2.13% 0.69% 0.44% 3) Ray Keeling, 46, is an experienced pharmaceutical manufacturing and supply executive, with particular expertise in sterile manufacture and meeting the requirements of the US FDA. Prior to joining ATp, Ray held senior supply operations positions at Aventis. 4) Dr. Manjit Rahelu, 38, has a PhD in immunology and over 7 years' experience in business development in the pharmaceutical industry (eg. Pfizer, UCB). Prior to joining ATp, Manjit was Senior Manager, Global Business Development and Licensing at UCB. This information is provided by RNS The company news service from the London Stock Exchange
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