OXFORD, UK – 27 September 2011 – Circassia Ltd, a specialty biopharmaceutical company
focused on allergy, today announced positive phase II clinical results showing that its
ToleroMune® hay fever vaccine substantially improved patients’ allergy symptoms compared
with those on placebo. The treatment was extremely well tolerated.
During the randomised, double-blind, placebo-controlled phase II study conducted in 50 hay
fever sufferers in Quebec, Canada, patients received four doses from one of five different
treatment regimes over a 12-week period. Five weeks later, investigators tested the patients’
skin and eye responses to grass pollen. The results show that the treatment reduced allergic
symptoms in patients’ eyes by up to 30% more than placebo. In addition, the therapy improved
early and late skin reactions by up to 54% and 19% above placebo respectively. The
ToleroMune T-cell vaccine had a similar safety profile to placebo.
Following these results, Circassia has initiated the final phase II trial of its hay fever treatment.
The double-blind, placebo-controlled study is underway in Kingston, Canada in 280 volunteers,
and will assess the effectiveness of the ToleroMune T-cell vaccine at improving patients’ nasal
symptoms and eye responses when exposed to grass pollen in an exposure chamber.
“Achieving these clinical results is particularly encouraging as hay fever is an extremely common
allergy, which can have a major impact on sufferers,” said Steve Harris, Circassia’s CEO.
“Many current therapies provide short-term symptom relief only, while traditional
immunotherapies can require specialist treatment over several years to address the underlying
disease. Circassia’s latest results follow earlier successful studies in a range of different
allergies. Our clinical data show that Circassia’s T-cell vaccines have the potential to
revolutionise allergy therapy, and these recent results give us the confidence to proceed with the
final phase II testing of our unique hay fever treatment.”
About Circassia’s allergy T-cell vaccines
Circassia is developing a range of allergy T-cell vaccines based on its proprietary ToleroMune®
technology. The company has successfully completed a number of phase II studies with its cat, house
dust mite, ragweed and grass allergy therapies. Clinical results show that short treatment regimes with
Circassia’s T-cell vaccines can greatly reduce patients’ allergic responses, 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
approximately 15% - 25% of people in these countries are sensitive to grass pollen. As a result, the
current allergy treatment market is valued at approximately $12 billion per year.
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 has raised
approximately £93 million ($159 million) and is backed by a syndicate of world-class venture capital and
institutional investors, including Imperial Innovations and Invesco Perpetual.
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