Directorate change and update
Allergy Therapeutics PLC
22 November 2005
Board Change and clinical update
Allergy Therapeutics ('ATp') today announces the following update on the
progress of its extensive clinical development programme:
* Recruitment into the pivotal Ragweed allergy vaccine trial, R204 (see note
1), has been completed with 228 patients randomised into the study.
Preliminary results are expected during the first quarter of 2006.
* The FDA has opened an IND (Investigational New Drug) file for ATp's
Ragweed Allergy Vaccine.
* Preliminary results show the phase I studies (G101, T101 and R101) (see
Note 2) have concluded, demonstrating greatly reduced allergenicity of ATp's
modified allergen containing products as compared with natural, unmodified
allergens.
Commenting on these clinical developments, Dr. Tom Holdich (R&D Director) said:
"The completion of recruitment for R204 represents a major milestone in Allergy
Therapeutics' development activities. Our first pivotal study is now moving to
the final clinical phase. The opening of an IND to cover Ragweed vaccines is
also an important achievement. We now have 3 INDs open (the other 2 for grass
and tree) and a clear path to conducting the clinical trials in the USA required
for registration in this, the world's largest market for treatments for Allergic
Rhinitis. Finally, it is rewarding to see the 101 studies confirming the success
of our modification process in reducing the allergenicity of the products and so
the improved safety as compared with native allergen".
ATp also announces the resignation from the board of Andrew Turnbull, Director
of Business Development and Supply Operations. Andrew will be replaced by Ray
Keeling as Head of Supply Operations and Manjit Rahelu as Head of Business
Development. Neither of these new positions involves a seat on the board. Brief
biographies of Ray and Manjit are set out below(Notes 3 and 4).
CEO Keith Carter said "These are very positive developments on our pipeline; the
Ragweed 204 study is our first major pivotal efficacy/safety study and as such
its progress is key. We are sorry that Andrew has made a decision to return to
his native New Zealand. His contribution to the growth of Allergy Therapeutics
has been enormous. We have however been very fortunate in being able to replace
him with two excellent specialists in the fields of Supply and Business
Development."
For further information:
Allergy Therapeutics 01903 844720
Keith Carter, Chief Executive
Bell Pottinger 020 7861 3232
Dan de Belder / Emma Charlton
Notes:
1) About R 204
A phase II clinical study in Canada using an advanced formulation of a ragweed
allergy vaccine. The study is 'pivotal' for Canada and would form the basis of a
New Drug Submission dossier without the need for further studies. Ragweed is a
large yellow weed producing pollen which is the primary cause of hay fever
symptoms in both Canada and the United States, where as many as 40 million of
the total population are affected.
The design of the trial is advanced, and utilises an environmental exposure
chamber (EEC). Patients are exposed to controlled quantities of ragweed pollen,
providing a simulation of a heavy pollen day. The treated patients will be
monitored for any resulting symptoms and these will be compared with patients
injected with a placebo vaccine. This innovative approach is felt to give far
greater accuracy than older measures of activity such as skin prick testing.
The new ragweed vaccine incorporates MPL(R), a TLR-4 agonist which acts as an
efficient allergy vaccine adjuvant. MPL(R) is incorporated in our existing
Pollinex Quattro pollen vaccine, currently enjoying success as a NPP (named
patient product) in Europe owing to its simple and fast 4-shot, 3-week course.
Pollinex Quattro has been shown to be both efficacious and safe in double-blind
placebo-controlled studies, and these results have been endorsed in
post-marketing surveillance studies, including those for children and
adolescents . Over 115,000 treatment sets have been sold in Europe to date as
NPP, mainly for allergic sensitivities to grass and tree pollens.
2) About the 101 studies
ATp's modern allergy vaccines are composed of 3 components i) Allergoids -
allergens modified to reduce their allergenicity whilst retaining their
immunogenicity, to allow safer more rapid up-dosing, ii) tyrosine - a depot
designed to release the vaccine gradually at the injection site, another safety
feature, and iii) MPL(R) - ATp's patented vaccine adjuvant incorporated to
improve the efficacy of the vaccines thereby creating an efficacious treatment
with greatly reduced number of injections.
The purpose of the three Phase I studies was to illustrate that the levels of
'residual allergenicity' after modification in ATp's allergoid products were
very low. The experiments were conducted by titrated Skin Prick Testing
comparing wheal size provoked by progressively attenuated native allergen
solution with solutions containing
1. allergoids alone,
2. allergoids plus tyrosine (MATA or Pollinex), and
3. allergoids plus tyrosine plus MPL(R) (Pollinex Quattro).
The results are as follows (expressed as % equivalent of native allergen to
produce a wheal size of equal area to that produced by the 100% concentration of
the modified product)
Modified Allergen MATA Pollinex Quattro
Grass 2.00% 0.25% 0.30%
Tree 4.00% 0.36% 0.33%
Ragweed 2.13% 0.69% 0.44%
3) Ray Keeling, 46, is an experienced pharmaceutical manufacturing and supply
executive, with particular expertise in sterile manufacture and meeting the
requirements of the US FDA. Prior to joining ATp, Ray held senior supply
operations positions at Aventis.
4) Dr. Manjit Rahelu, 38, has a PhD in immunology and over 7 years' experience
in business development in the pharmaceutical industry (eg. Pfizer, UCB). Prior
to joining ATp, Manjit was Senior Manager, Global Business Development and
Licensing at UCB.
This information is provided by RNS
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