Allergy Therapeutics PLC
02 April 2007
2 April 2007
Allergy Therapeutics plc
("Allergy Therapeutics" or "the Company")
Commencement of Dosing in Pollinex(R) Quattro Phase III Ragweed Trial
Now running the two largest international allergy vaccine trials ever conducted
Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company
focused on allergy vaccination, announces that it has commenced dosing in
patients in its pivotal Phase III ragweed allergy trial (R301). This trial will
be undertaken at more than 65 centres in the United States and Canada.
Pollinex Quattro is an ultra-short course vaccine requiring only four shots over
three weeks and incorporates the TLR4 agonist adjuvant MPL(R). In contrast,
existing vaccine treatments typically require between 16 and 50 injections taken
under specialist supervision prior to the start of the hayfever season. Pollinex
Quattro therefore has the potential to transform allergy treatment by providing
a safe, effective and highly convenient method of vaccination. The Company has
three programmes of Pollinex Quattro allergy vaccines in clinical development:
Grass, Tree and Ragweed.
The primary objective of this double blind, randomised trial is to compare the
efficacy and safety of Pollinex Quattro Ragweed versus placebo. The trial
design and endpoints have been approved by regulatory bodies, including the Food
and Drug Administration in the United States. This single pivotal trial, if
successful, is suitable for registration. A Biologics License Application is
planned for the second half of 2008.
This phase III trial follows a similar study with Pollinex Quattro Grass, which
commenced earlier this year. The Pollinex Quattro Ragweed study, positions the
Company to launch in 2009 the first two approved allergy vaccines in the United
States.
Evidence of the safety and efficacy of Pollinex Quattro has been established
through earlier clinical trials in Europe. Furthermore, substantial exposure
data in more than 87,000 patients is available from the named patient programme
in Europe.
The market opportunity is considerable with the American Academy of Allergy,
Asthma and Immunology estimating that 33 million allergy injections a year are
given in the United States. Allergic rhinitis (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*. Worldwide over 150 million people
are estimated to suffer from allergic rhinitis and the prevalence is increasing
*. There is a substantial unmet medical need in a market currently worth an
estimated US$12 billion per annum.
* Decision Resources Allergic Rhinitis June 2005
Keith Carter, Chief Executive of Allergy Therapeutics, said:
"Today's announcement represents another step towards Allergy Therapeutics' aim
of developing patient friendly, highly-effective treatments for hay fever
sufferers worldwide. For a company of our size to be conducting the two largest
allergy vaccine trials ever undertaken is a significant achievement."
Dr Harold Kaiser, Clinical Professor of Medicine at the University of Minnesota
Medical School, R301 Co-ordinating Principal Investigator, who enrolled the
first patient, said:
"I am pleased to be involved with this pivotal study with this innovative
allergy immunotherapy product. The benefit gained by the inclusion of the
adjuvant MPL - an alternative very short course of immunotherapy seems to me to
offer the potential of a convenient treatment option for busy physicians and
their patients."
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
About Pollinex Quattro
There are three programmes of subcutaneous immunotherapy in clinical
development; Pollinex Quattro Grass, Pollinex Quattro Ragweed & Pollinex Quattro
Tree, all of which are based on proprietary technologies. Collectively these
form the "Caution: Allergen" programme. Pollinex Quattro Ragweed is currently
under review by Health Canada. In addition, an oral vaccine development is
completing its first phase II study.
Pollinex Quattro vaccines contain three distinct technologies which act
synergistically. Natural allergens are chemically modified to improve safety and
allow for delivery of higher doses. These are combined with a depot technology
to provide prolonged desensitization and further improved tolerability. Finally,
the immune response is specifically enhanced and directed by an adjuvant,
monophosphoryl lipid A (MPL). MPL is a Toll-Like 4 Receptor (TLR4) agonist and
has been extensively tested in Pollinex Quattro and other late stage and
registered vaccines including GlaxoSmithKline's Fendrix(R) and Cervarix(R)
About Allergy Therapeutics plc
Allergy Therapeutics plc is a UK AIM-listed specialty pharmaceutical company
focused on allergy vaccination. It has a profitable core business achieving
sales of allergy vaccines of over £24m in Germany, Italy, Spain and other EU
markets through its own sales and marketing infrastructure.
This information is provided by RNS
The company news service from the London Stock Exchange
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