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Circassia Completes Patient Recruitment for Phase II Clinical Trial of Toleromune(R) Allergy Treatment

OXFORD, England, January 7 /PRNewswire/ -- Circassia Ltd, a specialty biopharmaceutical company focused on allergy and critical care, today announced that following successful clinical results achieved in 2008 with its ToleroMune(R) anti-allergy technology, the company has now completed patient recruitment for a further phase II clinical trial in cat allergy. The study, which is underway in Canada, has recruited 120 patients with confirmed cat allergies, and all the participants have completed screening and initial dosing with none experiencing any significant adverse events or safety issues. Circassia anticipates completing patient dosing in the next three months, with follow-up post-treatment challenge visits being completed by the end of April 2009.

The double-blind, randomized, placebo-controlled study is comparing several different ToleroMune treatment regimens, each with standardised doses administered over several weeks. This is in sharp contrast to most current allergy immunotherapies, which can require carefully titrated dosing over many months and even years. As part of the ongoing study, each patient is exposed to cat allergens in a controlled environmental exposure chamber both before and after receiving the study treatment. During these "challenges" the volunteers will monitor and record their allergic rhinitis symptoms to allow investigators to assess the effect of the ToleroMune treatment.

"We are delighted that this trial is making such rapid progress as it should define the optimal treatment approach for our ToleroMune cat-allergy therapy as it moves towards phase III testing," said Steve Harris, Circassia's CEO. "We are commited to introducing our ToleroMune treatment for cat allergy as quickly as possible because, despite its prevalence, the condition is poorly served by existing therapies due to their aggressive side-effect profile. ToleroMune offers allergists and their patients significant potential benefits. In particular, ToleroMune should greatly simplify and shorten allergy therapy, while minimizing the risk of the serious and even life-threatening adverse reactions that are associated with current desensitization treatments."

About Circassia

Circassia is a specialty biopharmaceutical company focused on the fields of allergy and critical care. The company has a highly experienced management team with a proven track record in product development and commercialization, and having successfully completed two fundraising rounds is backed by a syndicate of world-class venture capital and institutional investors, including Imperial Innovations, Lansdowne Partners, Goldman Sachs and Invesco Perpetual.

Circassia's anti-allergy products offer potential important 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 market for current treatments is approximately $12 billion per year. The prevalence of cat allergies is high, with 1-in-6 Americans and nearly 10% of Europeans suffering from the condition.

Circassia's lead products target allergies utilizing the company's proprietary T-cell epitope desensitization technology, ToleroMune. In addition to ToleroMune's potential therapeutic benefits, its state-of-the-art manufacturing processes fit with changes in the regulatory environment in Europe where authorities are increasingly treating allergen immunotherapies in the same manner as pharmaceuticals, and eliminating the batch-to-batch potency variability that is an intrinsic feature of many currrent products. Circassia is also developing ToleroTrans organ anti-rejection technology, which uses a similar approach to ToleroMune to down-regulate immune responses in transplant patients, and ToleroCare therapy which is designed to dramatically improve patient recovery following a range of high-risk surgeries.

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SOURCE Circassia Ltd
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