Allergy Thera. Regulatory News (AGY)

11 Jul 2007 10:01

Allergy Therapeutics PLC11 July 2007 11 July 2007 Allergy Therapeutics plc ("Allergy Therapeutics" or "the Company") Clinical Development Update Allergy Therapeutics announces that clinical activity on its Pollinex Quattroclinical studies has been placed on clinical hold by the FDA whilst the agencyfully assesses the report of a rare adverse event classified by the physicianinvolved as 'possibly related' to the study drug. The Company is collaborating fully with the FDA and has provided extensive data,both as part of the trial routine and supplementary data, including independentexpert assessment. Allergy Therapeutics has also reviewed all the dataavailable to it concerning this adverse event, considers that it is unlikelythat the event was caused by the study drug and is urgently working with the FDAto provide any additional information necessary to address and resolve FDA'sconcerns. Allergy Therapeutics has two ongoing Pollinex Quattro studies: Phase III Grass(G301) and Phase III Ragweed (R301), and has two about to commence/recommence:the Grass safety study (G302) and a Phase II Tree study (T204). Of these onlyR301 is directly affected as it is the only trial in the treatment phase. A full update will be provided as soon as the FDA gives material information onthe results of its review. Keith Carter, Chief Executive of Allergy Therapeutics, said: "The FDA has a difficult job to do in minimising risk to patients, both onclinical trials and from marketed pharmaceuticals. It is normal that theyshould exercise caution. We believe the evidence strongly supports the viewthat the event was unlikely to have been caused by Pollinex Quattro and we areseeking urgent clarification of the FDA's position." There will be a conference call for analysts at 11.00am. Please dial +44 (0)20 7138 0843 to access the call. For further information Allergy Therapeutics +44 (0) 1903 845 820Keith Carter, Chief Executive Tom Holdich, R&D Director Bridgewell +44 (0) 20 7003 3000Shaun Dobson Financial Dynamics +44 (0) 207 831 3113Ben Brewerton This information is provided by RNS The company news service from the London Stock Exchange