According to today's announcement made by Circassia Ltd, a specialty biopharmaceutical company focused on allergy, ToleroMune's® positive phase II clinical trials showed that the hay fever vaccine treatment was extremely well tolerated and substantially improved patients' allergy symptoms.
Researchers conducted a 12-week long, randomized, double blind, placebo-controlled phase II study in 50 hay fever sufferers in Quebec, Canada, by administering patients with four doses from one of five different treatment regimes. The safety profile of the ToleroMune T-cell vaccine was similar to that of placebo.
After five weeks the researchers examined patients' skin and eye responses to grass pollen and discovered that the treatment reduced allergic symptoms in patients' eyes by up to 30% more compared with the placebo group. They also found that the therapy improved early and late skin reactions by up to 54% and 19% respectively more compared with those administered with placebo.
Based on this study's results, Circassia has started the final phase II trial of its hay fever treatment. At present, the double blind, placebo-controlled study is underway in Kingston, Canada, involving 280 volunteers to examine ToleroMune T-cell vaccine's efficacy at improving patients' nasal symptoms and eye responses when exposed to grass pollen in an exposure chamber.
Steve Harris, Circassia's CEO commented:
"Achieving these clinical results is particularly encouraging as hay fever is an extremely common allergy, which can have a major impact on sufferers. Many current therapies provide short-term symptom relief only, while traditional immunotherapies can require specialist treatment over several years to address the underlying disease. Circassia's latest results follow earlier successful studies in a range of different allergies. Our clinical data show that Circassia's T-cell vaccines have the potential to revolutionize allergy therapy, and these recent results give us the confidence to proceed with the final phase II testing of our unique hay fever treatment."
About Circassia's allergy T-cell vaccinesBased on its proprietary ToleroMune® technology and after the company's successful completion of numerous phase II studies with its cat, house dust mite, ragweed and grass allergy therapies, Circassia is now developing a range of allergy T-cell vaccines for hay fever. Clinical results revealed that short-term therapies with Circassia's T-cell vaccines are extremely well tolerated and can significantly reduce patients' allergic responses without the need for adjuvants or other immune stimulators.
Based on these results and in comparison with existing therapies, the treatments provide major potential clinical benefits and have significant market opportunities. In the U.S. and Europe more than 150 million people suffer from allergic rhinitis. With approximately 15 to 25% of these people being sensitive to grass pollen, the value of the current allergy treatment market is estimated to be approximately $12 billion per year.
About CircassiaBased on the Oxford Science Park in the UK and in Hamilton, Canada, where its joint venture Adiga Life Sciences is located, Circassia was founded in 2006 by a team of highly experienced biotechnology scientists and entrepreneurs with Sir Richard Sykes, former chairman of GlaxoSmithKline as its chairman. Circassia's ToleroMuno technology was originally developed by scientists at the Imperial College in London. After successful completion of four fundraising rounds, Circassia raised approx. 159 million USD. It is supported by a syndicate of world-class venture capital and institutional investors, such as Imperial Innovations and Invesco Perpetual.
Written by Petra Rattue