Circassia’s Rapid Four-Dose ToleroMune® Treatment Maintains Significant Reduction in Allergy Symptoms During 12-Month Follow-up

June 13, 2011

OXFORD, England, June 13, 2011 /PRNewswire/ –

– Results Presented at Plenary Symposium of European Academy of Allergy
and Clinical Immunology Congress

– Cat Allergy T-cell Vaccine to Begin Phase III Testing in H1 2012

Circassia Ltd, a specialty biopharmaceutical company focused on allergy,
today announced the results of a phase II clinical trial showing that
patients who received four doses of its ToleroMune(R) cat allergy vaccine
over a 12-week period maintained a statistically significant reduction in
symptoms one year later. The results of the study were presented in the
opening Plenary Symposium of the European Academy of Allergy and Clinical
Immunology Congress on Sunday 12 June by Professor Mark Larche, Canada
Research Chair in Allergy and Immune Tolerance at McMaster University,

The study followed an earlier randomised double-blind phase II trial in
202 cat allergy patients, in which those who received four doses of
Circassia’s T-cell vaccine over 12 weeks had a significantly greater
improvement in their symptoms than those on placebo. The treatment was
extremely well tolerated.

The new results show that one year after the start of the original
study, the treated group’s tolerance to cat allergens was maintained, and
had continued to improve substantially following the completion of the
treatment, despite the patients receiving no booster doses. As a result,
immediately following treatment, the patients had experienced a 94%
improvement in their total rhinitis symptoms compared with placebo. By the
end of the 12-month study, the ToleroMune T-cell vaccine had reduced the
same patients’ symptoms by 133% more than placebo (p=0.01). This treatment
effect is 2.6 – 4.3 times that achieved by several currently approved
allergy therapies in key clinical trials.

Commenting on the study results, Professor Mark Larche, Canada Research
Chair in Allergy and Immune Tolerance, McMasterUniversity, said,
“Maintaining such a significant level of symptom improvement over an
extended period is a major step forward. Achieving this with a course of
just four doses is unprecedented, and represents an important breakthrough
that has the potential to lead to improved treatments for allergy sufferers

“We are extremely excited by these new clinical results, which again
demonstrate the potential of our ToleroMune technology to revolutionise
allergy treatment,” said Steve Harris, Circassia’s CEO. “These results,
achieved with our commercial room-temperature-stable formulation, clearly
show that Circassia’s T-cell vaccines offer the prospect of major clinical
and manufacturing benefits over traditional immunotherapies. We intend to
capitalise on these impressive results as quickly as possible, and having
recently completed one of the largest private fundraisings in the history of
European biotechnology, plan to advance our cat allergy treatment into phase
III testing in 2012.”

About Circassia’s allergy T-cell vaccines

Circassia is developing a range of allergy T-cell vaccines based on its
proprietary ToleroMune(R) technology. The company has successfully completed
a number of phase II studies with its cat, house dust mite and ragweed
allergy products, and its grass allergy therapeutic is in clinical testing.
Clinical results to date show that short treatment regimes with Circassia’s
T-cell vaccines can greatly reduce patients’ allergic reactions, without the
need for adjuvants or other immune stimulators, while proving extremely well
tolerated. As a result, the treatments offer major potential clinical
benefits compared with existing therapies, and 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.

About Circassia

Circassia was founded in 2006 by a team of highly experienced
biotechnology scientists and entrepreneurs, and is chaired by the former
Chairman of GlaxoSmithKline, Sir Richard Sykes. The company is based in the
UK on the Oxford Science Park, and in Hamilton, Canada, where its joint
venture Adiga Life Sciences is located. Its ToleroMune technology was
developed originally by scientists at Imperial College, London. Having
successfully completed four fundraising rounds Circassia is backed by a
syndicate of world-class venture capital and institutional investors,
including Imperial Innovations and Invesco Perpetual.

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


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

Source: newswire

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