October 3, 2008
Circassia Initiates Further Phase II Cat Allergy Study
Circassia, a specialty biopharmaceutical company, has started a further Phase II clinical study of its ToleroMune 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 four-dose treatment regimens, which are designed to enhance patient 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, the company said.
Steve Harris, Circassia's CEO, said: "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.
"The results of our trials to date show that our ToleroMune approach offers patients potential benefits. Circassia's anti-allergy technology has the potential to provide effective but shorter treatments, while minimizing the threat of severe side-effects."