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Circassia Announces Successful Phase II Study Meets Primary Endpoint and Extends Target Patient Population to Asthmatics for Cat Allergy T-Cell Vaccine
Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that its ToleroMune® cat allergy treatment has achieved positive phase II results in patients with allergy-associated asthma. The clinical study met its primary endpoint, demonstrating that the ToleroMune® therapy's safety profile was similar to that of placebo in this sub-group of patients who are potentially difficult to treat with current immunotherapies. The study follows two earlier phase II trials in broader populations of cat allergy sufferers, in which Circassia's T-cell vaccine was well tolerated and reduced patients' allergic reactions. The study was conducted in Canada, in 48 patients with confirmed cat-allergen induced asthma, over a period of several weeks. Throughout the trial, the ToleroMune® T-cell vaccine did not exacerbate patients' asthma or affect lung function, and was extremely well tolerated. This safety profile compares highly favourably with traditional immunotherapies, which have been associated with cases of severe and sometimes life-threatening adverse reactions, and require careful monitoring, particularly in patients with allergy-associated asthma. "These results are particularly encouraging as they demonstrate the potential of our ToleroMune® technology to treat patients whose allergies are more severe and may lead to asthma attacks," said Steve Harris, Circassia's CEO. "Our cat allergy T-cell vaccine has now successfully completed three phase II clinical trials, and the last study before its final phase of development is near completion. Our successful study in cat allergy-associated asthma extends the target patient group for this T-cell vaccine, resulting in a commercial opportunity of up to $1 billion annually in the US alone."
16 August 2010