Allergy Thera. Regulatory News (AGY)

2 Dec 2005 07:01

Allergy Therapeutics PLC02 December 2005 Allergy Therapeutics plc announces rescheduling of Grass Phase III trials Despite having completed its pre-phase III study programme on plan, followingconsultation with regulatory agencies Allergy Therapeutics plc ("the Company")has concluded that, having taken account of the seasonality of grass pollenallergic rhinitis, it is inappropriate to continue to plan to conduct itsworld-wide Phase III pivotal Grass pollen vaccine study ('G301') during the 2006pollen season. The Company has therefore deferred set-up activities on G301until later in 2006 and rescheduled this pivotal study to take place during the2007 pollen season. The Company continues to work towards an 'End of Phase II'meeting with the FDA in the early part of 2006. This work will also assist inthe planning for the Phase III Ragweed allergy vaccine study scheduled for laterin 2006. Commenting on this decision, Keith Carter, CEO, said: "It is well-known that we have an ambitious development programme. The GrassPhase 2 clinical studies have completed their clinical stage and are nowundergoing analysis. With this major work achieved, the rescheduling of G301 isdisappointing but we believe that it would be difficult to recruit the fullcomplement of 600 patients before the start of the 2006 pollen season. By takingthis decision now we have deferred most of the expenses of G301 by 12 months. We have full confidence in the product and believe that its potential will berealised. The Company has a strong pipeline and expects the clinical stage ofthe pivotal Ragweed allergy vaccine trial, R204, to complete in the near futurewith 'last patient treated' scheduled for 20 December - a major milestone in ourdevelopment activities." For further information: Allergy Therapeutics 01903 845820Keith Carter, Chief Executive Bell Pottinger 020 7861 3232Dan de Belder / Emma Charlton This information is provided by RNS The company news service from the London Stock Exchange