Clinical Trials
Allergy Therapeutics PLC
11 October 2006
POSITIVE OUTCOME FROM POLLINEX(R) QUATTRO RAGWEED DOSE RANGING STUDY AND
SUCCESSFUL COMPLETION OF PHASE II PROGRAMME
Allergy Therapeutics ("The Company") plc, the specialist pharmaceutical company
focused on allergy vaccination, announces today that it has achieved a positive
outcome in a dose-ranging study on Pollinex Quattro Ragweed and has now
successfully completed Phase II with this therapeutic vaccine.
Pollinex Quattro is an ultra-short course vaccine requiring only four shots in
three weeks and incorporates the TLR4 agonist adjuvant MPL(R). Pollinex Quattro
has the potential to transform allergy treatment, by providing a proven safe,
effective and convenient method of vaccination. The Company has three programmes
of Pollinex Quattro allergy vaccines in clinical development: Grass, Tree and
Ragweed. The Company is planning on commencing Phase III studies in both Ragweed
and Grass allergies in late 2006 and early 2007. With additional late stage
studies also planned in the treatment of Tree allergies, Pollinex Quattro is
entering the final stages of the largest ever allergy vaccine development
programme and the first conducted on a global basis. The Company expects to
launch the first ever approved allergy vaccine in the United States in 2009.
The dose ranging study, R203, demonstrated that the therapeutic dose of Pollinex
Quattro Ragweed is clearly immunogenic in a dose related manner. The therapeutic
dose showed a five fold increase in immune response (IgG) after only four
injections, as compared with a three fold increase in the intermediate dose
group and a two fold increase in the low dose group.
Since 2005, eleven studies have been conducted with Pollinex Quattro in North
America involving 700 patients. Further evidence of the safety and efficacy of
Pollinex Quattro is supported in clinical practice via data collected by the
Company during named patient use of the vaccine in over 79,000 sufferers in
Europe.
Keith Carter, Chief Executive Officer of Allergy Therapeutics, said: "Today's
announcement is the latest of a series of very positive development milestones
in the process for achieving global registration and commercialisation of
Pollinex Quattro. The global market for allergy vaccines is substantial and the
potential is huge. There are over 40 million individuals with allergic rhinitis
in the United States alone. The major causes of this disease are Grass, Tree and
Ragweed allergens and we are pleased to be able to offer these tens of millions
of patients a real chance for treatment in the near future. There is an
increasing interest in allergy vaccines and their potential to cure allergic
diseases. Of all companies active in allergy vaccines, Allergy Therapeutics is
best placed to take a leadership role."
Dr Lawrence DuBuske, President of the American Association of Certified
Allergists and Consultant in Allergy at Brigham and Women's Hospital, Harvard
Medical School, said "Pollinex Quattro represents a unique technological advance
incorporating recent understanding of the critical role of Toll Like receptor
activation in determining immune responses to potential allergens. The Pollinex
Quattro combination of modified allergen which reduces allergenicity while
preserving immunogenicity with simultaneous Toll like receptor activation
provides both rapid efficacy and enhanced safety for allergen specific
vaccination. Pollinex Quattro holds the promise of truly revolutionizing the
practice of allergy treatment."
-END-
For further information, please contact:
Allergy Therapeutics plc
Keith Carter, Chief Executive Officer +44 (0)1903 845 820
Bell Pottinger
Dan de Belder / Rosanne Perry +44 (0)207 861 3232
About the R203 Study
R203 was a double-blind, phase II study to evaluate the immunogenicity and
tolerability of different doses of Pollinex Quattro Ragweed conducted at 4 study
sites in North America under an FDA approved IND. 68 patients with a history of
moderate to severe seasonal rhinoconjunctivitis, a positive skin prick test and
a positive radioallergosorbent test (RAST) to ragweed allergen received 4 weekly
subcutaneous injections with one of the three test doses (therapeutic,
intermediate, low dose) or placebo. Immunogenicity was assessed by the serum
concentration of ragweed-specific immunoglobulins (specific IgG, IgG1, IgG4, and
IgE to Ragweed) compared between the three Pollinex Quattro Ragweed treatment
arms and placebo.
Pollinex Quattro Ragweed was able to induce immunoglobulin levels in a
dose-dependent manner. Significant increases in immunoglobulin levels from
baseline were most frequently detected, and of the highest magnitude, with the
therapeutic dose. This increase was statistically significant with a net change
in ragweed specific IgG of 445% vs. placebo (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 (swelling, itching and pain) the majority of which were reported as
mild.
About Pollinex Quattro
Pollinex Quattro is a four shot therapeutic vaccine for the treatment of
allergic conditions which offers immediate same season relief in as little as
three weeks after treatment. It is a family of specific standardised vaccines
representing a potentially extensive franchise for Allergy Therapeutics, and has
the potential to be a novel entrant in the multibillion dollar global allergy
market. Current therapeutic options in the United States and Europe are mainly
limited to symptomatic therapies and conventional allergen immunotherapy which
generally requires 60 to 90 shots in the United States and 30 to 60 shots in
Europe over three to five years. These long dosing regimes represent a
significant treatment burden for allergy sufferers. Allergy Therapeutics
believes that Pollinex Quattro has the potential to become the first of several
new and important disease modifying therapeutic options for patients and
physicians.
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 London Stock Exchange (AIM) listed specialist
pharmaceutical company focused on allergy vaccination. It has a profitable core
business achieving sales of allergy vaccines of over £24 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 progressing
to Phase III studies with Pollinex Quattro, the Company has commenced Phase I/II
oral vaccine studies incorporating MPL.
This information is provided by RNS
The company news service from the London Stock Exchange