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Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber
Date:8/27/2008

and time course of sublingual immunotherapy (SLIT) administered as 300IR allergen-based tablets once daily to 86 adults suffering from grass pollen rhinoconjunctivitis. The main objectives of the study were to assess the efficacy of grass pollen extract SLIT tablets compared to placebo on the average Rhinoconjunctivitis Total Symptom Score (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes), to evaluate the onset of action after different treatment durations (1 week, 1 month, 2 and 4 months) through the challenge test, to identify immunological parameters as possible biomarkers for SLIT, and to assess safety. Since patients were not allowed to take any rescue medication, the symptom score was not impacted by its usage and the difference between the placebo and active group was due exclusively to the effect of the Oralair(R) Grasses tablet.

ABOUT THE ALLERGEN CHALLENGE CHAMBER (ACC)

The Allergen Challenge Chamber is already recognized as a supportive study by the FDA and the European Medicines Agency (EMEA). The interest of ACC as an assessment tool for clinical development is confirmed. The Allergen Challenge Chamber (ACC) offsets the unpredictability of the pollen season, and thereby avoids the variable nature of pollens and patient exposure and facilitates follow up.

About oralair(R) Grasses

Oralair(R) Grasses is a fast-dissolving tablet that has demonstrated high efficacy in treating allergic rhinoconjunctivitis to grass pollen starting with the first season, lasting throughout the pollen season, and at the pollen peak, on:

- Poly- and mono-sensitised patients, as well as asthmatic

patients,

- Every individual symptom, and in particular on nasal

congestion and watery eyes.

Oralair(R) Grasses is a pre-seasonal treatment: it has to be started four months before the pollen season, be maintained throughout the season, and then stopped and restarted the following s
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SOURCE Stallergenes
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