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STALLERGENES: Persistent Efficacy Demonstrated After a Year on Actair(R) Followed by a Second Treatment-Free Year
Date:6/28/2010

ANTONY, France, June 28, 2010 /PRNewswire-FirstCall/ -- After having announced positive results for the first year of its phase IIb/III clinical trial (VO 57.07) conducted on Actair(R) sublingual allergen immunotherapy tablets in allergic rhinitis triggered by house dust mites in April 2009, Stallergenes S.A. today announces the results of the second year of this study.

Following this first year which demonstrated positive results for both the dosages tested (300 IR[1] and 500 IR) and which is key for the marketing authorization application, the second year of the study involved an exploratory evaluation of the persistence of the therapeutic effect of Actair(R) in the following year. Out of the 509 patients originally included in the study, 397 participated until the end of the second year. The primary endpoint for this second year was the Average Adjusted Symptom Score (AAdSS)[2] measured one year after the end of treatment.

The results of this second year demonstrate not only that the efficacy of Actair(R) persists well beyond the first six months after treatment is stopped but also that the size effect is globally equivalent to that observed in the first year. Thus in the main assessment period for the efficacy endpoint (between 10 and 12 months after the discontinuation of treatment), both active groups demonstrated a persistent effect of the treatment, with a statistically significant difference for the AAdSS versus placebo [(p=0.0342) for the 300 IR dosage; (p=0.0229) for the 500 IR dosage], still with no difference between the two treated groups.

This study is a world first in that, for the first time, it indisputably demonstrates the persistence of the effect of sublingual allergen immunotherapy in perennial allergic rhinitis triggered
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