Circassia's Allergy Therapy Begins Phase II Clinical Trial in Asthm... ( OXFORD England April 21 /- Circas...)

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

Date:4/21/2009

OXFORD, England, April 21 /PRNewswire/ -- 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 lastest 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."

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