Circassia Achieves Major Reduction in Allergic Reactions to House Dust Mite in Phase II Clinical Study of Novel T-cell Vaccine

OXFORD, England, November 18, 2010 /PRNewswire/ -- Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced successful clinical results from a phase II study of its T-cell vaccine targeting house dust mite allergy. The study met each of the safety and efficacy endpoints, with the optimal treatment regimen achieving a major reduction in patients' reactions to house dust mite allergens. These results build on four earlier successful phase II studies of Circassia's ToleroMune(R) technology, which scientifically validated the use of novel T-cell vaccines in treating allergies. Circassia is currently conducting a number of ongoing phase II clinical trials with its therapies for grass (hayfever), cat and ragweed allergies.

Circassia undertook its most recent phase II clinical study in Quebec City, Canada, in 50 patients with confirmed house dust mite allergies. Patients received four standardised doses of ToleroMune T-cell vaccine over a number of weeks. During the study, investigators administered a challenge dose of house dust mite allergen to the volunteers' skin and eyes to assess the impact of the ToleroMune therapy. The results show that the optimal treatment regimen reduced each of the allergic reactions assessed during the study, achieving a therapeutic effect 32% - 87% greater than placebo.

"These positive clinical results, achieved with our house dust mite allergy treatment, are particularly encouraging as they mirror those from earlier successful studies with our cat and ragweed allergy therapies," said Steve Harris, Circassia's CEO. "Our rapidly growing clinical database clearly demonstrates the potential of Circassia's T-cell vaccines to greatly improve allergy treatment, by offering sufferers a convenient and well tolerated alternative to existing immunotherapies. We have made significant progress in advancing a number of allergy T-cell vaccines into mid- to late-stage development, and we continue to work hard to bring these innovative therapies to market as quickly as possible."

About Circassia's allergy T-cell vaccines

Circassia's range of allergy T-cell vaccines is based on its proprietary ToleroMune(R) technology. This technology utilises allergen epitopes to generate regulatory T cells that suppress allergic immune responses. Clinical results with Circassia's allergy T-cell vaccines show that short treatment regimes can greatly reduce patients' allergic reactions, without the need for adjuvants or other immune stimulators, while proving extremely well tolerated. As a result, the company's allergy treatments offer major potential 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 vaccines are manufactured chemically, in contrast to existing allergen immunotherapies, which are purified from natural sources. Circassia's approach applies the manufacturing and quality standards associated with conventional pharmaceuticals to its allergy T-cell vaccines. This fits with changes in the European regulatory environment, where authorities increasingly require the elimination of batch-to-batch potency variability that is an intrinsic feature of many current treatments.

About Circassia

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

    Contacts

    Steve Harris
    CEO
    Circassia
    Tel: +44(0)1865-784574
    http://www.circassia.co.uk

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

SOURCE Circassia Ltd