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Circassia Initiates Phase II Clinical Study With Novel Anti-Allergy Technology
Date:2/27/2008

OXFORD, England, February 27 /PRNewswire/ -- Circassia Ltd, a specialty biopharmaceutical company focused on controlling immune system responses, announced today that it has initiated a phase II clinical study with its anti-allergy technology, ToleroMune. Circassia is conducting the study in the field of cat-dander allergy, and aims to complete the trial in the coming months.

This clinical study builds on the results of a previous double-blind, placebo-controlled phase II trial, which provided proof-of-concept for the ToleroMune technology. The current double-blind, placebo-controlled phase II trial will study both safety and surrogate efficacy outcomes, following escalating doses administered via two different routes (intradermal and subcutaneous). The study is taking place in Germany in up to 11 patient cohorts, with each containing 8 subjects with cat-dander allergy. Trial recruitment is progressing rapidly, and dosing is complete in the first patient cohort and ongoing in the second and third groups of patients.

"With clinical proof-of-concept already established for our ToleroMune technology, this phase II study will provide us with valuable data on both the most appropriate route of administration and dose optimization, which should be applicable across our entire anti-allergy product range," said Steve Harris, Circassia's CEO. "This study is particularly important for Circassia, moving our lead product closer to market, and at the same time establishing a development pathway for our other anti-allergy products."

Circassia's anti-allergy products have the potential to address significant market opportunities. Currently, over 150 million people suffer from allergic rhinitis in the US and Europe. The prevalence of cat-dander allergy is also high, with approximately 17% of Americans and 9% of Europeans suffering from the condition. Existing treatments have a number of issues, either providing symptomatic relief only or requiring length
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