Clinical update
Allergy Therapeutics PLC
06 March 2006
Allergy Therapeutics plc announces the completion of Pollinex(R) Quattro Phase
II Grass programme and positive outcome of study G203
Allergy Therapeutics plc, the specialty pharmaceutical Company focused on
allergy vaccination, announces today the successful completion and positive
outcome of its key Phase II dose-ranging study, G203. The positive study results
support the plan to take the Company's lead product, Pollinex Quattro, into
Phase III.
The G203 study is part of the Company's development of ultra short course
allergy vaccines, under the brand name Pollinex Quattro, and relates
specifically to the treatment of patients allergic to grass pollen. The results
of this study demonstrate that Pollinex Quattro Grass - Grass M.A.T.A. (Modified
Allergen Tyrosine Absorbate) with MPL(R) (Monophosphoryl Lipid A) - was safe and
well tolerated at all dosing regimens and increased antibody levels compared to
placebo in a dose-dependent manner. MPL is the Company's innovative TLR4-agonist
which acts as an efficient allergy vaccine adjuvant.
In this double-blind study, three dose regimens involving four injections of
Pollinex Quattro were compared to placebo in 74 patients allergic to grass and
rye pollen at three centres in North America. Analyses show all 3 treatment
groups had increased immunoglobulin levels over time relative to baseline
levels. The immunogenicity response was most increased after treatment with the
current therapeutic dose regimen of the vaccine compared to placebo. The
incidence and nature of adverse experiences were as expected with a subcutaneous
vaccine and were not dose-related.
These results support the plans to take Pollinex Quattro into Phase III.
Pollinex Quattro efficacy has also been demonstrated in previous double blind
controlled studies and safety experience has been gained from >60,000 named
patient exposures.
Dr. Tom Holdich, head of R & D, said
"This latest study, conducted in response to an FDA information requirement,
adds to an already considerable body of clinical data on the Pollinex Quattro.
The product has already been shown to be safe and effective in double-blind
placebo-controlled studies and during extensive post-marketing surveillance
which includes children and adolescents."
Keith Carter, Chief Executive Officer, said:
"The completion of our pre-phase III programme brings us one step closer to
delivering the first and only simple, four shot allergy vaccine therapy to
patients worldwide.
"Pollinex Quattro has sold over 115,000 treatment sets in Europe and was awarded
the 2005 prestigious MMW-Arzneimittelpreis prize in Germany for pharmaceutical
innovation."
-ends-
For further information:
Allergy Therapeutics plc
Keith Carter, Chief Executive Officer 01903 845 820
Bell Pottinger
Daniel de Belder/Emma Charlton 020 7861 3232
About the G203 Study
G203 was a double-blind, phase II study to evaluate the immunogenicity and
tolerability of different doses of Grass M.A.T.A. MPL conducted at 3 study sites
in North America under an FDA approved IND. Seventy-four patients with a history
of moderate to severe seasonal rhinoconjunctivitis, a positive skin prick test
and a positive radioallergosorbent test (RAST) to grass and rye allergen
received 4 weekly subcutaneous injections with one of the three study test
products (therapeutic regimen, intermediate dose, or low dose) or placebo.
Immunogenicity was assessed by the serum concentration of grass-specific
immunoglobulins (specific IgG, IgG1, IgG4, and IgE to Timothy, June and Rye)
compared between the three Grass M.A.T.A. MPL treatment arms and placebo.
The effect of Grass M.A.T.A. MPL on immunoglobulin levels appeared to be
dose-dependent. Significant increases in immunoglobulin levels from baseline
were most frequently detected, and of the highest magnitude, with the
therapeutic dose regimen containing the highest concentrations of Grass M.A.T.A.
MPL, followed by the intermediate dose regimen, reaching statistical
significance in the therapeutic group versus the placebo group (Timothy Grass
IgG net change vs placebo 59.9%, p<0.05). There were no serious adverse
experiences or severe systemic reactions reported during the study. The
commonest reported adverse experiences were injection site reactions (pain
(active 58%; placebo 40%), itching and swelling). However, the majority of
adverse experiences were mild and overall the incidence and nature of adverse
experiences was not dose related.
About MPL and M.A.T.A.
MPL (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 4 Receptor (TLR4) agonist. Allergy Therapeutics
is conducting a programme of late phase trials in injected vaccines (Pollinex
Quattro) with the adjuvant and GSK has several vaccine candidates containing MPL
including Fendrix(R), a vaccine for Hepatitis B which was approved by the EMEA
last year.
M.A.T.A .stands for Modified Allergen Tyrosine Absorbate, other key components
of the product which enhance both safety and efficacy of the vaccine and enable
this ultra short treatment regimen.
About Allergy Therapeutics plc
Allergy Therapeutics plc is a London Stock Exchange (AIM) listed speciality
pharmaceutical company focused on allergy vaccination. It has a profitable core
business achieving sales of allergy vaccines of over £22 million 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 United Kingdom, Poland, the Czech Republic, Slovakia
and Austria.
Allergy Therapeutics manufactures its own vaccine products in a MHRA approved
sterile manufacturing facility in Worthing, United Kingdom. In January 2006 the
Company successfully underwent an audit by the MHRA.
Allergy Therapeutics has certain exclusive intellectual property rights to the
use of MPL in both injected and sublingual vaccines. In addition to preparing
for Phase III studies with Pollinex Quattro, the Company has commenced Phase I/
II sublingual vaccine studies incorporating MPL.
This information is provided by RNS
The company news service from the London Stock Exchange