LEIDEN, Netherlands, November 6, 2012 /PRNewswire/ --
HAL Allergy B.V. today announced that it has successfully completed patient enrollment in its Phase II trial with SUBLIVAC® FIX Birch. This combined dose tolerability and dose range finding study will characterize the dose-response relationship of SUBLIVAC® FIX Birch in order to support the optimal dose in terms of clinical efficacy and safety.
The multi-centre, randomized, double-blind, placebo-controlled study in patients with persistent allergic rhinitis / rhino conjunctivitis was initiated in July 2012 and will be completed in March 2013. More than 250 patients were included in 21 clinical sites in the Czech Republic, Poland and Germany. Completion of enrollment is an important milestone in the clinical development program of SUBLIVAC® FIX Birch.
"Timely patient recruitment is often a major hurdle in clinical trials. We are very proud that recruitment has been successful and appreciate the hard work of our investigators and the clinical trial team to meet the tight recruitment deadlines that are an integral part of studies with seasonal allergens. This reinforces our confidence in our ambitious clinical development program for gaining registration for specific immunotherapy products" 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 SUBLIVAC® FIX Birch
SUBLIVAC® FIX Birch is an allergen extract of birch pollen for sublingual 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 medication.
About HAL Allergy
The HAL Allergy Group 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 270 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