Circassia's Allergy Therapy Begins Phase II Clinical Trial in Asthma Patients

Circassia announced today that it has initiated a phase II clinical study of its ToleroMune(R) technology in allergy patients with asthma

OXFORD, England | April 21, 2009 | Circassia Ltd, a specialty biopharmaceutical company focused on allergy, announced today that it has initiated a phase II clinical study of its ToleroMune(R) technology in allergy patients with asthma. The trial builds on positive phase II results that demonstrated the potential clinical benefits of ToleroMune allergy therapy, and extends clinical investigations to those with allergy-associated asthma. The latest study, which is underway in Canada, will enrol 48 patients with confirmed cat allergies and cat-allergen induced asthma. The randomised, double-blind, placebo-controlled trial will study the use of a standard dose of ToleroMune administered over a number of weeks. This is in marked contrast to most current immunotherapy treatments, which require carefully escalated weekly dosing over many months, followed by further monthly doses for several years, to reduce the risk of potentially serious adverse reactions. During the study, each patient will receive a controlled 'challenge' with cat allergens, both before and after treatment, to allow investigators to assess the effect of ToleroMune  therapy compared to placebo.

"This study marks an important milestone in the development of our ToleroMune anti-allergy technology, as it extends our target patient group to those with more serious allergies that can result in asthma attacks," said Steve Harris, Circassia's CEO. "We believe that Circassia's allergy therapies will offer patients important clinical benefits. Most existing treatments address either symptoms only, or require lengthy and complicated dosing because of their potential to lead to serious and even lifethreatening reactions. In contrast, our clinical results show that ToleroMune has the potential to treat the underlying causes of allergies, using short and simple courses of treatment that minimize the risk of severe side effects."

About Circassia

Circassia is a specialty biopharmaceutical company focused on the field of allergy. The company's range of allergy therapeutics utilizes its proprietary T-cell epitope desensitization technology, ToleroMune. Circassia's anti-allergy products offer potential major 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 also high, with 1-in-6 Americans and nearly 10% of Europeans suffering from the condition.

ToleroMune technology has additional potential regulatory and supply benefits for Circassia. Its state-of-the-art manufacturing fits with changes in the European regulatory environment, where authorities are increasingly treating allergen immunotherapies as pharmaceutical products, and  eliminating the batch-to-batch potency variability that is an intrinsic feature of many currrent treatments.

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

SOURCE: Circassia Ltd

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