LEIDEN, The Netherlands, March 20, 2012 /PRNewswire/ --
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.
About Allergic Rhinitis
Allergic rhinitis is a common chronic inflammatory disease of the upper airways characterized by symptoms such as sneezing, nasal itch, rhinorrhea, and nasal congestion. The prevalence is estimated to be as high as 25% in developed countries. The disease has an impact on the quality of life of patients and is associated with considerable direct and indirect costs. The most recent estimate of the annual costs of allergic rhinitis range from $2 to 5 billion in the USA (2003 values).
About PURETHAL® Mites
PURETHAL® Mites is a modified aluminum hydroxide-adsorbed extract of house dust mites for subcutaneous use. The product is in commercial use and is primarily prescribed for patients suffering from severe allergic respiratory diseases inadequately controlled despite the use of symptomatic treatments.
About HAL Allergy
The HAL Allergy Group (http://www.hal-allergy.com) was established in 1959 and is a main European manufacturer of allergy vaccines and diagnostics. The Group's products are distributed via subsidiaries in Germany, Spain, Italy, Poland, Austria and the Benelux as well as a network of distribution partners around Europe. Currently HAL Allergy employs over 280 people throughout Europe with more than 160 situated in the Netherlands HQ. The German subsidiary in Düsseldorf, in operation since 1977 and one of the top three players in the largest allergy market, employs 60 people and is the main sales and marketing operation for the HAL Allergy Group.
SOURCE HAL Allergy