Circassia’s Ragweed Allergy Therapy Achieves Positive Phase II Clinical Results

OXFORD, England, March 8, 2012 /PRNewswire/ --

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that its ragweed allergy therapy has achieved positive results in a key phase II clinical trial. In the study, patients with more severe symptoms achieved a significantly greater improvement following treatment with the ToleroMune T-cell vaccine than those on placebo (p0.05). The results were presented at the 2012 Annual Meeting of the American Academy of Allergy, Asthma and Immunology*.

"The results of this key phase II study are highly encouraging, because they show our ToleroMune ragweed allergy vaccine can reduce patients' symptoms after just a short course of treatment and, most importantly, offers the greatest improvement to those who can benefit most," said Steve Harris, Circassia's CEO. "We have now achieved successful phase II results with four of our allergy T-cell vaccines, which validate our scientific approach and give us the confidence to progress our lead programmes into the final phase of development."

Circassia's latest phase II study was designed to assess the T-cell vaccine's efficacy and tolerability and to identify the optimal treatment regime. The trial was conducted in Canada in 275 ragweed allergy patients. During the randomised, double-blind, placebo-controlled trial, volunteers received one of four regimens of ToleroMune treatment over a three-month period. Patients were exposed to ragweed allergens in a validated exposure chamber, and investigators compared their nasal and ocular symptoms against the pre-treatment baseline. The results show that the T-cell vaccine's optimal regimen substantially reduced patients' symptoms, achieving a 97% greater reduction than placebo (p0.05) in subjects who had a moderate level of symptoms at baseline. The treatment was safe and well tolerated in all groups.

About Circassia's allergy T-cell vaccines

Circassia is developing a range of allergy treatments based on its proprietary ToleroMune technology, which utilises small sections of allergens (epitopes) to generate regulatory T cells that suppress allergic immune responses, and thereby desensitise patients. 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. More than 150 million people suffer from allergic rhinitis in the US and Europe, and over 25% of the population of the United States and a growing number of Europeans are sensitive to ragweed pollen. As a result, the current allergy treatment market is valued at 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 has raised approximately 93 million ($159 million) and is backed by a syndicate of world-class institutional investors, including Imperial Innovations and Invesco Perpetual.

* Hafner R et al. Validation of peptide immunotherapy as a new approach in the treatment of allergic rhinoconjunctivitis: The clinical benefits of treatment with Amb a 1 derived T cell epitopes.

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Circassia's Ragweed Allergy Therapy Achieves Positive Phase II Clinical Results