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Company News: Anergis Starts European Phase IIb Clinical Trial with AllerT in Patients with Moderate to Severe Allergy to Birch Pollen

– First patient treated with novel allergy vaccine –

Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today that it has treated the first patient in a large, well-controlled Phase IIb clinical trial in individuals with birch pollen allergy. The trial is designed to evaluate the efficacy and tolerability of a 5-injection / 2- months treatment with Anergis´ lead allergy vaccine, AllerT.

The multicentre, double-blind, placebo-controlled, randomized trial called AN004T was designed in collaboration with an International Steering Committee of experts with comprehensive experience in the design and conduct of allergen-specific immunotherapy trials⁽¹⁾. The trial will enroll about 300 patients with moderate to severe birch pollen allergy from up to 30 trial centers throughout Europe. Trial centers are located in Denmark, France, Latvia, Lithuania, Poland, Sweden and Switzerland. AN004T will evaluate the efficacy and safety of two doses of AllerT in comparison with placebo. The first patient was randomized and treated on November 3^rd, 2012, in Vilnius, Lithuania.

As recommended by the European Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases (CHMP/EWP/18504/2006), the efficacy of AllerT will be assessed using a combined symptom and medication score as primary endpoint of the trial (combined Rhinoconjunctivitis Symptom and Medication Score RSMS). RSMS assessment is based on allergy symptom and medication data reported through electronic diaries by the trial subjects during the 2013 birch pollen season. Secondary and exploratory endpoints will include other clinical parameters related to symptoms and/or medications taken for allergy, as well as quality of life and immunological marker assessments.