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Stallergenes: Oralair: Very Positive 3-Year Results of the Long-Term Study
Date:12/7/2009

PARIS, December 7 /PRNewswire-FirstCall/ --

- Very Positive 3-Year Results of the Long-Term Study Provide Confirmation of the Clinical Relevance of Oralair(R)

Stallergenes S.A. today announces the 3-year results of a phase III clinical trial (VO53.06) to assess the long-term (sustained) effect and disease modifier effect after discontinuation of treatment of its sublingual grass pollen immunotherapy tablet, Oralair(R). This study is the first ever pivotal study designed to be a long-term and disease modifier trial from the outset.

The VO53.06 study is a randomized, double-blind, placebo-controlled phase III trial conducted over 5 years, 3 years as a pre- and coseasonal treatment regimen and the following 2 years without treatment. It included 633 patients, aged 18 to 50 years, with grass pollen-related allergic rhino-conjunctivitis, in 45 centers in 10 countries. The patients were divided in two treated groups and one placebo group. In the two active arms, there was no dose escalation and the daily dose was a 300 IR sublingual immunotherapy tablet. In one active arm, the treatment started 4 months before the pollen season, and in the other, 2 months before. The total treatment duration for each study-year in all groups was 5 to 6 months up until the end of the pollen season.

The sustained clinical efficacy as defined by EMEA[1] guidelines is the measurement of treatment efficacy after 3 years. The primary endpoint was the Average Adjusted Symptom Score (AASS)[2].

In the third year analysis, the two treated groups demonstrated a statistically significant reduction of AASS in comparison with placebo (p<0.0001) with a very large effect.

                 Relative differences versus placebo (season 3)


            2 months  4 months
     Mean     -36%      -34%
    Median    -50%      -48%

A reduction of 40% was achieved in the 2nd year an
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SOURCE Stallergenes
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