Allergy Thera. Regulatory News (AGY)

22 Nov 2005 07:03

Allergy Therapeutics PLC22 November 2005 Board Change and clinical update Allergy Therapeutics ('ATp') today announces the following update on theprogress 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 AllergyTherapeutics' development activities. Our first pivotal study is now moving tothe final clinical phase. The opening of an IND to cover Ragweed vaccines isalso an important achievement. We now have 3 INDs open (the other 2 for grassand tree) and a clear path to conducting the clinical trials in the USA requiredfor registration in this, the world's largest market for treatments for AllergicRhinitis. Finally, it is rewarding to see the 101 studies confirming the successof our modification process in reducing the allergenicity of the products and sothe improved safety as compared with native allergen". ATp also announces the resignation from the board of Andrew Turnbull, Directorof Business Development and Supply Operations. Andrew will be replaced by RayKeeling as Head of Supply Operations and Manjit Rahelu as Head of BusinessDevelopment. Neither of these new positions involves a seat on the board. Briefbiographies of Ray and Manjit are set out below(Notes 3 and 4).CEO Keith Carter said "These are very positive developments on our pipeline; theRagweed 204 study is our first major pivotal efficacy/safety study and as suchits progress is key. We are sorry that Andrew has made a decision to return tohis native New Zealand. His contribution to the growth of Allergy Therapeuticshas been enormous. We have however been very fortunate in being able to replacehim with two excellent specialists in the fields of Supply and BusinessDevelopment." For further information:Allergy Therapeutics 01903 844720Keith Carter, Chief Executive Bell Pottinger 020 7861 3232Dan de Belder / Emma Charlton Notes:1) About R 204A phase II clinical study in Canada using an advanced formulation of a ragweedallergy vaccine. The study is 'pivotal' for Canada and would form the basis of aNew Drug Submission dossier without the need for further studies. Ragweed is alarge yellow weed producing pollen which is the primary cause of hay feversymptoms in both Canada and the United States, where as many as 40 million ofthe total population are affected.The design of the trial is advanced, and utilises an environmental exposurechamber (EEC). Patients are exposed to controlled quantities of ragweed pollen,providing a simulation of a heavy pollen day. The treated patients will bemonitored for any resulting symptoms and these will be compared with patientsinjected with a placebo vaccine. This innovative approach is felt to give fargreater 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 anefficient allergy vaccine adjuvant. MPL(R) is incorporated in our existingPollinex Quattro pollen vaccine, currently enjoying success as a NPP (namedpatient 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-blindplacebo-controlled studies, and these results have been endorsed inpost-marketing surveillance studies, including those for children andadolescents . Over 115,000 treatment sets have been sold in Europe to date asNPP, 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 theirimmunogenicity, to allow safer more rapid up-dosing, ii) tyrosine - a depotdesigned to release the vaccine gradually at the injection site, another safetyfeature, and iii) MPL(R) - ATp's patented vaccine adjuvant incorporated toimprove the efficacy of the vaccines thereby creating an efficacious treatmentwith 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 werevery low. The experiments were conducted by titrated Skin Prick Testingcomparing wheal size provoked by progressively attenuated native allergensolution with solutions containing1. allergoids alone,2. allergoids plus tyrosine (MATA or Pollinex), and3. allergoids plus tyrosine plus MPL(R) (Pollinex Quattro).The results are as follows (expressed as % equivalent of native allergen toproduce a wheal size of equal area to that produced by the 100% concentration ofthe modified product) Modified Allergen MATA Pollinex QuattroGrass 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 supplyexecutive, with particular expertise in sterile manufacture and meeting therequirements of the US FDA. Prior to joining ATp, Ray held senior supplyoperations positions at Aventis.4) Dr. Manjit Rahelu, 38, has a PhD in immunology and over 7 years' experiencein business development in the pharmaceutical industry (eg. Pfizer, UCB). Priorto joining ATp, Manjit was Senior Manager, Global Business Development andLicensing at UCB. This information is provided by RNS The company news service from the London Stock Exchange