Allergy Therapeutics PLC
07 December 2006
Thursday 7 December 2006
Allergy Therapeutics plc
Promising data from oral allergy vaccine study
Preliminary results show potential for a rapid action, injection-free allergy
treatment
Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company
focussed on allergy vaccination, announces that it has received promising
initial data in its Phase IIa study of an oral (sub-lingual) grass allergy
vaccine. This study gives confidence that Allergy Therapeutics can develop an
effective, rapid-onset, orally delivered allergy vaccine.
Allergy Therapeutics' new generation of allergy vaccines use MPL(R), an
innovative TLR4-agonist which boosts and accelerates the immune response. This
study is the first ever examination of oral delivery of MPL in man. MPL is
currently used in injectable form by GlaxoSmithKline within their range of
anti-infective vaccine products.
Preliminary results from the first 3 active treatment groups show:
• The vaccine was safe and well tolerated with minimal local side effects
and no patients withdrawn or discontinued.
• The vaccine showed systemic effects and was immunologically active. A
significant increase against placebo in grass specific antibodies was seen
after 8 weeks of once a day administration in the two MPL-containing
treatment groups.
• The vaccine improved symptoms. These immunological changes were mirrored
by clinical improvements (as measured by nasal challenge) in the
MPL-containing groups.
The full analysis and results from the final group (high dose MPL plus high dose
allergen) will be available in the first quarter of 2007.
What does it mean for allergy sufferers?
Allergic rhinitis (or hay fever) is a large and growing problem. Prevalence
estimates vary on a country by country basis but range from 14-29% of the total
population (1). Worldwide over 150 million people are estimated to suffer from
allergic rhinitis1 and the prevalence is increasing.
Allergy Therapeutics is already in the latter stages of seeking regulatory
approval for a ultra-short course, four injection MPL-based treatment, Pollinex
(R) Quattro. This therapeutic vaccine has been used in a number of European
countries on a named patient basis and over 79,000 patients have been safely
treated.
The development of a convenient, effective, short course, oral vaccine would
have significant implications for allergy therapy and redefine the market for
allergy products. There is a substantial unmet medical need and substantial
costs to society including US$12 billion of spending on pharmaceuticals.
Keith Carter, Chief Executive of Allergy Therapeutics, said:
"Allergy Therapeutics' objective is to transform allergy treatment. Our
technology is able to increase the effect of allergy vaccines by priming the
immune system. This will enable us, following approval, to reduce the current
regime in the United States of 40 injections to just 4 injections. Now it looks
like we are able to produce a similar effect in oral vaccines. These results
provide the first indication that we have the technology to deliver a painless,
patient friendly, injection-free, potentially curative allergy treatment.
"We firmly believe that both our oral and subcutaneous vaccine formulations are
potentially "best in class" and promise life-improving benefits for the millions
of sufferers world-wide."
Linda Cox, MD, FAAAAI, Chair of the AAAAI Immunotherapy and Allergy Diagnostics
Committee, said:
"Allergy sufferers need new treatments which deliver better symptom control and
are potentially curative. Allergy Therapeutics seems to have been able to
demonstrate significant enhancement of the speed and convenience of the
products, both injected and now oral. This may offer physicians additional
treatment options and patients a vastly improved quality of life".
For further information
Allergy Therapeutics +44 (0) 1903 844 722
Keith Carter, Chief Executive
Financial Dynamics +44 (0) 207 831 3113
David Yates
Ben Brewerton
(1) Decision Resources Allergic Rhinitis June 2005
Study GSL103
The study, GSL103, was the first ever conducted in man using orally delivered
(sub-lingual) allergen in combination with MPL. MPL is an innovative
TLR4-agonist which boosts and accelerates the immune response. The initial part
of the study involved three groups of 20 grass allergic patients treated with
extracts of grass pollen either alone or in combination with different doses of
MPL compared to placebo. The patients' symptoms were assessed by nasal challenge
in addition to sampling to measure induction of grass specific antibodies.
This information is provided by RNS
The company news service from the London Stock Exchange
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