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Circassia Initiates Further Phase II Clinical Study of Toleromune(R) Anti-Allergy Technology

OXFORD, England, October 2 /PRNewswire/ -- Circassia Ltd, a specialty biopharmaceutical company focused on the fields of allergy and critical care, today announced the start of a further phase II clinical study of its ToleroMune(R) technology in the field of cat allergy. The trial builds on positive results achieved in an earlier phase II study, which demonstrated the potential clinical benefits of the ToleroMune approach to allergy desensitization.

In the previous phase II clinical trial, patients experienced substantially reduced reactions to cat allergens after a single administration of ToleroMune therapy. The current study builds on this work, and will explore different 4-dose treatment regimens, which are designed to enhance the patients' response and determine the best therapeutic approach. During the study, patients will receive a controlled dose of cat allergen in an environmental exposure chamber both before and after treatment, and will then complete a questionnaire to score their allergic rhinitis symptoms. This will allow investigators to evaluate the impact of the different treatment regimes. The double-blind, randomized, placebo-controlled trial will include a total of 120 volunteers with confirmed cat allergies. The study, which is already underway in Canada, is progressing well with approximately 20% of patients enrolled for screening so far.

"This study is of great importance for Circassia as it is designed to define the most effective treatment regime for our ToleroMune allergy products, and in particular for the phase III studies of our cat-allergy therapy that are planned to begin in the second half of 2009," said Steve Harris, Circassia's CEO. "The results of our trials to date show that our ToleroMune approach offers patients substantial potential benefits. Conventional allergy treatments either address symptoms only or require many doses over a period of months under specialist supervision because they can result in serious, even life-threatening adverse reactions. In contrast, Circassia's anti-allergy technology has the potential to provide effective but shorter treatments, while minimizing the threat of severe side-effects."

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 lead products target allergies utilizing the company's proprietary T-cell epitope desensitization technology, ToleroMune. The company is also developing its ToleroTrans organ anti-rejection technology, which uses a similar approach to down-regulate immune responses in transplant patients.

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 also high, with 1-in-6 Americans and nearly 10% of Europeans suffering from the condition.

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