HAL Allergy Completes Patient Enrollment for its Phase II Trial With PURETHAL® Mites
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(R) 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(R) 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(R) Mites
PURETHAL(R) 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 Duesseldorf, 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