Date: 2012-11-08
Type of
information: Results
phase: 1-2a
Announcement: results
Company: Anergis (Switzerland)
Product: AllerT
Action
mechanism:
Disease: birch pollen allergy
Therapeutic
area: Allergic diseases - Immunological diseases
Country:
Trial
details:
Latest
news:
- Anergis has announced new data on the immune-regulatory effect of its AllerT vaccine. Patients with birch pollen allergy who received an ultra-fast allergy vaccine four years ago maintain an elevated level of antibodies against the allergen. 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.
“These results indicate again that the immune system of patients was durably affected by the 2-months treatment with AllerT, which was administered 40-42 months earlier. This means that a long-term immunological memory appears to be present in AllerT-treated subjects,” said Christophe Reymond, Ph.D., CSO of Anergis.
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.
Is
general: Yes
