HAL Allergy Completes Patient Enrollment for its Phase II Trial With SUBLIVAC® FIX Phleum Pratense

LEIDEN - The Netherlands, December 19, 2012 /PRNewswire/ --

HAL Allergy B.V. today announced that it has successfully completed patient enrollment in its Phase II trial with SUBLIVAC® FIX Phleum pratense. This combined dose tolerability and dose range finding study will characterize the dose-response relationship of SUBLIVAC® FIX Phleum pratense in order to support the optimal dose in terms of clinical efficacy and safety for further investigation in Phase III studies.

This multi-centre, randomized, double-blind, placebo-controlled study in patients with persistent allergic rhinitis / rhinoconjunctivitis was initiated in September 2012 and will be completed in May 2013. More than 250 patients were included in 23 clinical sites in Germany and Poland. The completion of enrollment is an important milestone in the clinical development program of SUBLIVAC® FIX Phleum pratense.  

"Together with the ongoing studies with PURETHAL® Mites and SUBLIVAC® FIX Birch this is the third dose range finding study within a period of one year for which we have completed patient enrollment. All three studies are part of our state-of-the-art clinical trial program to support final licensure of the products under the enactment of the German Regulation on Therapy Allergens (i.e., "Therapieallergene-Verordnung"). The on time patient enrollment for all three studies demonstrates that we are fully committed and capable to meet the goals of this program. Results will be available mid-2013, subsequently, the first Phase III pivotal trials will be initiated in 2014" 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 in developed countries is estimated to be as high as 25%. The disease has an impact on the quality of life of patients and is associated with considerable direct and indirect costs. The most recent (Datamonitor 2005) estimate of the annual costs of allergic rhinitis is $10 billion and these costs are rising, particularly in the industrialised world.

About SUBLIVAC® FIX Phleum pratense

SUBLIVAC® FIX Phleum pratense is an allergen extract of Phleum pratense pollen for sublingual use. The product is in commercial use and is primarily prescribed for patients suffering from severe allergic respiratory diseases caused by grass pollen and which have inadequate disease control 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.