Oct 31 2011
HAL Allergy B.V. today announced that it has included the first patient in its PHASE II dose range finding study. This multi-centre, randomized, double-blind, placebo-controlled study in 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 has been initiated in September 2011 in 5 European countries.
PURETHAL® Mites is currently on the market in Germany and several other European countries on a named patient basis. Due to changes in the regulatory landscape immunotherapy products containing common allergens (such as house dust mite) can remain on the market but require a development program that is designed to obtain full marketing authorization. The approval and start of this study are important steps to obtain final licensure for the use of PURETHAL® Mites in the treatment of immediate type allergic disorders (IgE-mediated), such as allergic rhinitis and allergic conjunctivitis induced by house dust mite allergy. It follows the submission of a marketing authorization application (November 2010) for PURETHAL® Mites at the Paul-Ehrlich-Institute, the regulatory authority in Germany.
The design of the study complies with the current state of the art guidelines on the clinical development of products for specific immunotherapy for the treatment of allergic diseases and the German Regulation on Therapy Allergens.
"The initiation of this trial is an important milestone for HAL Allergy's clinical development plan. It also stresses our commitment to meet today's requirements for gaining registration for specific immunotherapy products," says Harry Flore, CEO of HAL Allergy.