Circassia completes recruitment for Phase II allergic rhinitis trial

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.

The double-blind, randomized, placebo-controlled study is comparing several different ToleroMune treatment regimens, each with standardized 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, the company said.

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.

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.

Steve Harris, CEO of Circassia, said: 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.

We are committed 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.