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Circassia Completes Patient Recruitment For Phase II Clinical Trial Of ToleroMune Allergy Treatment
OXFORD, UK - 7 January 2009 - 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® 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."
07 January 2009