Clinical update
Allergy Therapeutics PLC
21 June 2006
Allergy Therapeutics plc, "Allergy Therapeutics" or "the Company"
Commencement of long term follow up study for Pollinex(R) Quattro Ragweed - R205
Quality of Life Information - R204
Allergy Therapeutics plc (AIM: AGY), the specialty pharmaceutical company
focused on allergy vaccination, today announces that it has completed
recruitment for its clinical trial, R205. The study is a one-year follow-up to
the pivotal ragweed study, R204, that has already demonstrated Pollinex(R)
Quattro's highly significant safety and efficacy benefits following one
ultra-short course of treatment of 4 injections.
Results from the R204 study showed a highly significant improvement in patients'
symptoms after treatment with Pollinex Quattro (48% relative improvement over
placebo, p=0.004). Disease modifying, allergen immunotherapy is the only
treatment able to alter the course of allergic diseases; potentially preventing
further sensitisations and reducing the progress from allergy to asthma. This
follow-up study is designed to investigate the long term benefits of Pollinex
Quattro and whether further benefit is gained by re-treating the patients one
year after the initial treatment. The data obtained in this study is expected to
aid in the understanding of the mechanism and duration of response of this
disease modifying, potentially curative therapy. In addition, the information
gained from R205 will be used to support the worldwide registration of Pollinex
Quattro.
The R205 study is being conducted in an environmental exposure chamber ('EEC').
Patients allergic to ragweed pollen, and previously treated with Pollinex
Quattro before the 2005 pollen season, will be challenged, receive a further
course of Pollinex Quattro and subsequently re-exposed to ragweed pollen in the
EEC. Preliminary results from the study should be available in Q1 2007.
The Pollinex Quattro allergy vaccines, which require only four injections over a
three week period, have the potential to transform allergy treatment by
providing a convenient, safe, effective and potentially curative method of
vaccination. Pollinex Quattro Ragweed is being developed predominantly for the
North American market where 26.2% of the population is sensitised to the ragweed
allergen. Further global studies are being conducted in patients allergic to
pollen from trees and grasses.
Additional results from R204
The analysis of the results of R204 continues and the Company today announces
the highlights of the quality of life ('RQLQ') measures incorporated in the
study. This section of the study is designed to measure the effect of Pollinex
Quattro on the patients' lifestyle and illustrates the positive effect of the
vaccine on their ability to carry out day-to-day activities.
Big improvements were observed in all measured domains; in particular there was
a highly significant improvement in the "Practical Problems" category (43%
improvement vs baseline, 137% relative improvement vs placebo; p= 0.0004). This
section encompasses important, practical irritations of allergic
rhinoconjunctivitis, such as blowing the nose frequently, rubbing the nose and
eyes, and the constant need for tissues or handkerchiefs.
Keith Carter, Chief Executive Officer, said:
"From the positive pivotal outcome of our Pollinex Quattro(R) Ragweed study,
R204, we know that Pollinex Quattro is highly effective in reducing symptoms of
allergy to ragweed. Pollinex Quattro provided this significant benefit after
only 4 injections taking only three weeks. Comparable symptom reduction would
only normally be expected after 20 to 40 injections of treatment using an
old-style long-course allergy vaccine. This finding is now endorsed by these
excellent RQLQ results. The new study, R205, will give us an insight into the
duration of these excellent patient benefits, and the value of repeated
treatment in the second year.
At Allergy Therapeutics, we continue to make good progress in the development of
our pipeline of innovative MPL-based ultra-short-course allergy vaccines, which
we believe have the potential to cure the allergies which cause misery for
millions during the pollen seasons."
-ends-
For further information:
Allergy Therapeutics plc
Keith Carter, Chief Executive Officer +44 (0)1903 845 820
Bell Pottinger
Dan de Belder / Emma Charlton +44 (0)20 7861 3232
About RQLQ
The Rhinoconjunctivitis Quality of Life Questionnaire was developed to measure
the problems that adults with rhinoconjunctivitis, both atopic and non-atopic,
experience as a result of their nose and eye symptoms. It is in both
self-administered and interviewer-administered formats. Patients are asked to
recall their experiences during the previous week and to give their responses on
a 7-point scale. The questionnaire has excellent evaluative and discriminative
properties and has been used extensively throughout the world in a large number
of clinical trials. R 204 study participants were asked to indicate their
experiences under a number of headings in a RQLQ questionnaire modified to suit
the EEC: 'non-nose/eye symptoms', 'practical problems', 'emotional' and 'global
assessment' - scoring symptoms as better or worse on a graded scale.
About MPL
MPL(R) (Monophosphoryl Lipid A) is an immunostimulatory substance used to
enhance the performance of vaccines (an 'adjuvant'). It has been widely tested,
and can be characterized as a Toll-Like Receptor 4 (TLR4) agonist. Allergy
Therapeutics is conducting a programme of late-phase trials of injected allergy
vaccines formulated with MPL, and GSK has several vaccines in their pipeline
containing MPL including Fendrix(R), a vaccine for Hepatitis A which was
approved by the EMEA last year.
About Allergy Therapeutics plc
Allergy Therapeutics plc is an AIM-listed specialty pharmaceutical company
focused on allergy vaccination. It has a profitable core business achieving
sales of allergy vaccines of over £22m in Germany, Italy, Spain and other EU
markets through its own sales and marketing infrastructure. The company is
expanding its infrastructure and recently commenced operations in the UK,
Poland, Austria, the Czech Republic and Slovakia.
Allergy Therapeutics has certain exclusive intellectual property rights to the
use of MPL in vaccines, both injected and oral. In addition to a phase I/II oral
proof of concept study, the Company is preparing for Phase III studies of
Pollinex(R) Quattro, an ultra-short course injected allergy vaccine comprising
four injections administrable over as little as 3 weeks during the pollen
pre-season. Discussion with the FDA and other regulatory authorities is ongoing
for this late stage programme and it is hoped that the programme will be
initiated on a worldwide basis during 2006.
This information is provided by RNS
The company news service from the London Stock Exchange