Tag: desensitization
Company News: Long-Term Immunomodulation Induced by Anergis´ COP Allergy Vaccine AllerT Now Extends to the 4th Year After Treatment
Patients with birch pollen allergy who received an ultra-fast allergy vaccine four years ago maintain an elevated level of antibodies against the allergen, reports Swiss biopharmaceutical company Anergis.
The company, which is developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, today announced new data on the immune-regulatory effect of its AllerT vaccine.
In 2008/2009, twenty patients suffering from moderate to severe allergies to birch pollen were enrolled in a double-blind, randomized, placebo-controlled Phase I/IIa trial and received 5 subcutaneous injections over 2 months of either AllerT (N=15) or placebo (N=5). Four years later, all subjects were invited to return to the trial center. In subjects who had received AllerT, blood levels of so-called IgG4 antibodies against specific birch pollen allergens were similar to those reported after 2 years (in 2010) and still 4.5 times higher than the pre-treatment baseline level (p< 0.001). Placebo-treated patients showed no median change from baseline in allergen-specific IgG4 at any time during the trial treatment period, nor after the 2010 and 2012 birch pollen seasons.
Earlier this week, Anergis also announced the start of a large, 300-patient real-life seasonal efficacy phase IIb trial with AllerT in patients allergic to birch pollen. This trial is being conducted in multiple European countries [NCT01720251].
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 3rd, 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.
Company News: Anergis Reaches Important Milestones with Second Product Candidate AllerR
– US Regulatory path for new vaccine against ragweed pollen allergies established –
Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today that it has reached several preclinical development milestones with AllerR, a novel allergy vaccine candidate for the treatment of patients with allergies to ragweed pollen. In addition, the company received positive feedback from the FDA on its AllerR development program.
In the development of AllerR, its second allergy vaccine candidate, Anergis reached essential preclinical milestones and held its first meeting with the US FDA in preparation for the first clinical trial of AllerR in patients allergic to ragweed pollen.
In preclinical experiments carried out by Anergis, binding of the AllerR peptides to IgE antibodies of allergic patients remained consistently undetectable in all conditions tested. In mice pre-sensitized to ragweed pollen, AllerR, unlike natural ragweed allergens, did not elicit an anaphylaxis-like response. And, importantly, AllerR was found to elicit antibody responses in mice, in which the antibodies recognized the natural ragweed allergens. Following collection of these data, Anergis held a pre-IND meeting with the U.S. FDA during which the regulatory path was clearly established until and including the clinical Phase I trial protocol.