Results Mark Third Successful Phase II Study With ToleroMune(R) T-Cell Vaccines
Feb. 12, 2010 (PR Newswire) -- Circassia Achieves Positive Phase II Clinical Results With Ragweed Allergy T-Cell Vaccine
OXFORD, England, February 12 /PRNewswire/ -- Circassia Ltd, a specialty
biopharmaceutical company focused on allergy, today announced that its
ToleroMune(R) ragweed allergy T-cell vaccine achieved positive results in a
recently completed phase II clinical trial. Ragweed allergy is particularly
common in America, where it affects approximately 25% of the population.
Circassia's latest clinical results follow two earlier successful phase II
studies with the company's T-cell vaccine against cat allergy. The company
has three additional phase II trials ongoing, targeting house dust mite and
cat allergies, and plans to initiate three further studies in the coming
months, extending the portfolio into the field of grass allergy.
The results from Circassia's latest clinical study demonstrate that four
doses of the ToleroMune T-cell vaccine greatly improved the allergic
responses measured in the trial. The efficacy endpoints, which included the
early phase skin response to a challenge dose of ragweed allergen, were
measured both before and after the ragweed season. This response, which is
commonly used by allergists to assess allergic status, showed a
characteristic increase in the placebo group by the end of the ragweed
season, resulting in values 37% higher than baseline. In contrast, the
optimal ToleroMune T-cell vaccine regime reversed this seasonal increase and
reduced it by a further 47% compared with the pre-ragweed season baseline.
Throughout the study, the ToleroMune vaccines were safe and well tolerated,
with a treatment-related safety profile similar to placebo.
"These highly encouraging clinical results further validate our unique
T-cell vaccine approach to allergy therapy. Our ToleroMune technology has now
shown its potential to address both ragweed and cat allergies, and we hope to
extend this product range when we receive the results of our ongoing study in
house dust mite allergy later this year," said Steve Harris, Circassia's CEO.
"With three phase II studies now complete, our growing clinical database
demonstrates the true potential of our ToleroMune T-cell vaccines. Unlike
current immunotherapies, which require increasing doses over a number of
months and several years of maintenance, ToleroMune therapy is short and
simple, and minimises the risk of the severe and sometimes life-threatening
side effects associated with many existing treatments."
About Circassia's allergy T-cell vaccines
Circassia's range of allergy T-cell vaccines is based on its proprietary
ToleroMune(R) technology.