Circassia Initiates Key Phase II Clinical Trial of House Dust Mite Allergy Treatment
Large-scale Study to Investigate Optimal Treatment Regimen for Phase III Programme
Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that the company has initiated a key phase II clinical study of its ToleroMune® house dust mite allergy treatment. The trial follows earlier successful phase II results with the T-cell vaccine. The new study is designed to determine the optimal treatment regimen for the final stage of clinical testing, and marks an important development milestone for the novel therapy.
The double-blind, randomized, placebo-controlled trial currently underway in Toronto, Canada is designed to assess the safety and efficacy of four short-course regimens of ToleroMune T-cell vaccine administered over three months. Investigators are enrolling 160 volunteers with confirmed house dust mite allergies, and will measure their nasal and ocular symptoms while exposed to house dust mite allergens in a controlled environmental exposure chamber. The study will compare the initial baseline levels with similar measurements made after treatment to determine the T-cell vaccine's effectiveness. Results are anticipated in 2013.
"This study advances the third of Circassia's ToleroMune allergy therapies into late-stage development, further demonstrating the great clinical progress we have made in the last two years," said Steve Harris, Circassia's CEO. "We have already achieved positive phase II results with our cat, ragweed, grass and house dust mite allergy treatments, and with this new large-scale study we aim to further extend the clinical data base supporting our unique T-cell vaccine approach. House dust mite allergies affect a huge number of people worldwide, and by undertaking this key trial we hope to move closer to making our ToleroMune therapy available to those who suffer from this common condition."
15 October 2011