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Circassia Announces Successful Results From Phase II Clinical Study of ToleroMune(R) Cat Allergy Therapy

November 20, 2009

OXFORD, England, November 20 /PRNewswire/ — Circassia Ltd, a specialty
biopharmaceutical company focused on allergy, today announced positive
results from a recently completed phase II clinical study of its
ToleroMune(R) cat allergy therapy, which successfully identified the optimal
dosing regimens to progress into late-stage development. The clinical trial,
which was the first of its kind in the field of cat allergy immunotherapy,
showed that Circassia’s ToleroMune treatment was extremely well tolerated and
greatly reduced sufferers’ symptoms.

Circassia conducted the double-blind study in Canada, where 121 subjects
with confirmed cat allergies were randomised to receive placebo or one of
four different treatment regimes with standardised doses of ToleroMune. The
volunteers were exposed to cat allergens (aerosolised dander) in an
environmental exposure chamber for 3 hours each day on four consecutive days,
both before and after treatment. At set time points the subjects scored their
ocular and nasal symptoms to allow investigators to measure the effect of the
ToleroMune treatment. This is the first trial of a cat allergy immunotherapy
to use this validated approach.

The study’s results demonstrate that ToleroMune therapy can dramatically
reduce both nasal and ocular allergy symptom levels, and that the treatment
effect grows as the duration of exposure increases and symptoms are at their
greatest. The optimal regimen decreased total symptom scores by 67% compared
with placebo. Throughout the study ToleroMune treatment was extremely well
tolerated, with a safety profile similar to placebo. This contrasts with many
traditional immunotherapies, which are associated with a range of local
tolerability issues and sometimes severe and even life-threatening adverse
events.

“These positive phase II results are extremely important for Circassia as
they identify the optimal treatment regime to move into the final stages of
development for our cat allergy therapy, and will prove invaluable as we
progress our broader portfolio of ToleroMune products,” said Steve Harris,
Circassia’s CEO. “We are particularly pleased that the ToleroMune treatment
achieved such a marked improvement in ocular symptoms, which can be a
particular problem in cat allergy. As well as benefiting patients, this
effect scientifically validates the ToleroMune approach and its novel focus
on generating regulatory T cells to shut down this type of IgE-mediated
allergic response.”

About Circassia

Circassia is a specialty biopharmaceutical company focused on the field
of allergy. The company’s range of allergy therapeutics utilises its
proprietary T-cell epitope desensitisation technology, ToleroMune, in a short
treatment regime without the need for adjuvants or other immune stimulators.
Circassia’s products offer potential major clinical benefits compared with
existing therapies, and consequently have significant market opportunities.
Over 150 million people suffer from allergic rhinitis in the US and Europe,
and the current treatment market is approximately $12 billion per year.

ToleroMune technology has additional potential regulatory and supply
chain benefits. The short peptides utilised in Circassia’s products are
manufactured chemically, in contrast to existing allergen immunotherapies,
which are purified from natural sources. Circassia’s approach applies the
chemistry, manufacturing and control standards associated with conventional
pharmaceuticals to immunotherapy. This fits with changes in the European
regulatory environment, where authorities are increasingly treating allergen
immunotherapies as pharmaceutical products, and requiring elimination of the
batch-to-batch potency variability that is an intrinsic feature of many
currrent treatments.

Circassia has a highly experienced management team with a proven track
record in product development and commercialisation. Having successfully
completed two fundraising rounds the company is backed by a syndicate of
world-class venture capital and institutional investors, including Imperial
Innovations, Lansdowne Partners, Goldman Sachs and Invesco Perpetual.

    For more information please visit http://www.circassia.co.uk.

    Contacts

    Steve Harris
    CEO
    Circassia
    Tel: +44-(0)1865-784574

    Rob Budge
    RJB Communications
    Tel: +44-(0)1865-760969
    Mobile: +44-(0)7710-741241

SOURCE Circassia Ltd


Source: newswire



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