Mar 21 2012
HAL Allergy B.V. today announced that it has successfully completed patient enrollment in its Phase II dose range finding study. This multi-centre, randomized, double-blind, placebo-controlled study in 250 patients with persistent allergic rhinitis / rhinoconjunctivitis will characterize the dose-response relationship of PURETHAL® Mites in order to support the optimal dose in terms of clinical efficacy and safety.
The study was initiated in September 2011 and will be completed beginning of 2013. More than 250 patients were included in 35 clinical sites in 5 European countries. Completion of enrollment is an important step in the clinical development program for PURETHAL® Mites. It stresses HAL Allergy's commitment to meet today's requirements for gaining registration for specific immunotherapy products.
"We are proud to have reached this important milestone according to schedule. We appreciate the commitment of our investigators, the clinical trial team, and all the patients who have volunteered for this important study. This reinforces our confidence that our ambitions will be realized," says Harry Flore, CEO of HAL Allergy.
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