Allergy Thera. Regulatory News (AGY)

24 Jul 2007 10:41

Allergy Therapeutics PLC24 July 2007 24 July 2007 Allergy Therapeutics plc ("Allergy Therapeutics" or "the Company") Clinical Development Update On 11 July 2007 Allergy Therapeutics announced that activity on its clinicalstudies had been placed on hold by the United States Food and DrugAdministration ('FDA') whilst the agency fully assesses the report of a rareadverse event classified at that time by the physician involved as 'possiblyrelated' to the study drug (the 'Adverse Event'). Allergy Therapeutics continues urgently to investigate the detail of the AdverseEvent, and can notify that the treating physician has stated that, pendingfurther tests, in her opinion the patient's symptoms resulted from analternative diagnosis, of a condition which would be unrelated to the studyvaccine. The Company also continues to collaborate fully with the FDA, toprovide new data as it is accumulated and remains confident that following itsongoing reviews the FDA will accept the alternative diagnosis. Owing to the approaching pollen season, Allergy Therapeutics' ongoing Phase IIIRagweed trial (R301) has had to be definitively moved to the observation phase.Prior to the clinical hold, 992 patients had been recruited onto this study, 92%of the target of 1074. Of these, approximately 300 have received all fourinjections and can therefore be considered to be participating in the study 'perprotocol'. Of the balance, about 300 had received 3 injections, 165 two and 227one injection. Although the Company anticipates that useful data will becollected from this study, it is sufficiently compromised that it is highlyunlikely to reach its primary endpoint. Therefore, completion of the Ragweedprogramme will require a further study to complete the patient numbers, probablyto be conducted next year. As a consequence the date for launch of Ragweed inNorth America will be 12 months later than previously anticipated. The Grass efficacy study G301 was already fully recruited and all treatment hadbeen completed when the FDA clinical hold was applied and will complete itscourse as planned; however, the associated safety study cannot be commenceduntil the hold is lifted. As a result, the grass programme may also suffer somedelay in the USA, although this would not necessarily be a full year dependingupon when the clinical hold is lifted. The Company will continue to give updates as and when new information becomesavailable. For further information Allergy Therapeutics +44 (0) 1903 845 820Keith Carter, Chief ExecutiveTom Holdich, R&D Director Bridgewell +44 (0) 207 003 3131Shaun Dobson Financial Dynamics +44 (0) 207 831 3113Ben Brewerton This information is provided by RNS The company news service from the London Stock Exchange