Circassia's ToleroMune(R) T-cell Vaccine Achieves Significant Reduction in Allergy Symptoms in Key Phase II Clinical Study

- Study Provides Proof-of-Concept for Commercial Formulation and Final Stage of Development

OXFORD, England | February 1, 2011 | Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that the company's ToleroMune(R) cat allergy treatment significantly reduced patients' symptoms in a recently completed, large-scale phase II clinical trial. The study also confirmed the treatment's highly favourable safety profile. The successful trial represents an important development milestone for Circassia's ToleroMune T-cell vaccine technology. The study was the first to use the company's commercial room-temperature-stable formulation, and provides confirmatory proof-of-concept for the final stage of development of its cat allergy T-cell vaccine.

"These clinical results are extremely good news, both for patients and for Circassia," said Steve Harris, Circassia's CEO. "By achieving a significant reduction in symptoms after just four doses, whilst also proving extremely well tolerated, our novel T-cell vaccine has demonstrated the true potential of ToleroMune to revolutionise allergy treatment. Our approach contrasts sharply with traditional immunotherapies, which can require dosing over a number of years under expert supervision due to the possibility of severe and even life-threatening reactions. These new clinical results, combined with our earlier successful phase II studies, scientifically validate both our ToleroMune technology and the commercial formulation we intend to progress into the final stage of development."

About the clinical trial

Circassia conducted the double-blind phase II study in Toronto, Canada, where investigators randomised 202 cat allergy patients to receive either four or eight standardised doses of ToleroMune treatment, or placebo. To determine the effect of the therapy, the volunteers systematically recorded their nasal and ocular allergy symptoms, both before and after treatment, whilst exposed to aerosolised cat allergens in a validated environmental exposure chamber.

The study results show that the ToleroMune T-cell vaccine had an immediate and growing treatment effect as allergen exposure increased. The key patient group, which received four doses of the T-cell vaccine over a period of 12 weeks, had significantly reduced levels of allergy symptoms when compared with placebo (p=0.05). These patients experienced a 55% greater improvement in their symptoms despite a larger than anticipated placebo effect. Throughout the study the ToleroMune treatment was extremely well tolerated, with a safety profile similar to placebo. Circassia is currently conducting a 12-month follow-up study to determine the duration of the treatment effect, with results anticipated in the second half of 2011.

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 its ToleroMune technology was developed originally by scientists at Imperial College, London. Having successfully completed three fundraising rounds Circassia is backed by a syndicate of world-class venture capital and institutional investors, including Imperial Innovations, Invesco Perpetual, Goldman Sachs and Lansdowne Partners.

SOURCE: Circassia

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