Allergy Therapeutics PLC
02 December 2005
Allergy Therapeutics plc announces rescheduling of Grass Phase III trials
Despite having completed its pre-phase III study programme on plan, following
consultation with regulatory agencies Allergy Therapeutics plc ("the Company")
has concluded that, having taken account of the seasonality of grass pollen
allergic rhinitis, it is inappropriate to continue to plan to conduct its
world-wide Phase III pivotal Grass pollen vaccine study ('G301') during the 2006
pollen season. The Company has therefore deferred set-up activities on G301
until later in 2006 and rescheduled this pivotal study to take place during the
2007 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 in
the planning for the Phase III Ragweed allergy vaccine study scheduled for later
in 2006.
Commenting on this decision, Keith Carter, CEO, said:
"It is well-known that we have an ambitious development programme. The Grass
Phase 2 clinical studies have completed their clinical stage and are now
undergoing analysis. With this major work achieved, the rescheduling of G301 is
disappointing but we believe that it would be difficult to recruit the full
complement of 600 patients before the start of the 2006 pollen season. By taking
this 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 be
realised. The Company has a strong pipeline and expects the clinical stage of
the pivotal Ragweed allergy vaccine trial, R204, to complete in the near future
with 'last patient treated' scheduled for 20 December - a major milestone in our
development activities."
For further information:
Allergy Therapeutics 01903 845820
Keith Carter, Chief Executive
Bell Pottinger 020 7861 3232
Dan de Belder / Emma Charlton
This information is provided by RNS
The company news service from the London Stock Exchange
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