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Stallergenes S.A.: Positive Results From a Phase IIb/III Clinical Trial on the House Dust Mite Desensitization Tablet
Date:4/29/2009

ANTONY, France, April 29 /PRNewswire-FirstCall/ -- Stallergenes S.A. announces the release of the first year outcome of its phase IIb/III clinical trial (VO 57.07) on a sublingual house dust mite desensitization tablet.

"We are very pleased with the outcome of this study, which is the first large study to ever demonstrate the efficacy of house dust mites allergen in treating perennial allergic rhinitis. Furthermore, the unexpected quick onset of action and the good safety profile are addressing the needs of patients with moderate to severe forms of the disease. This study will be pivotal in the European registration process of our house dust mites sublingual tablet, and the basis for further developments in our program" states Albert Saporta, Chairman and CEO of Stallergenes. "This study is a genuine landmark which confirms desensitization as a new therapeutic class in the management of allergic respiratory disorders. Stallergenes has been consolidating its leadership in this field through its innovative and development capabilities".

Stallergenes has been conducting a phase IIb/III clinical trial, with a sublingual tablet in adults suffering from moderate to severe persistent allergic rhinitis to house dust mites, including 509 patients, over seven countries, with a full year of treatment from January to December 2008. This study compared two treated groups, one with a daily intake of 300 IR[1] sublingual tablet, the other of 500 IR, with a placebo group. The endpoint was the adjusted average symptom score on nasal symptoms assessed during the three last months of the year.

The two treated groups have demonstrated a highly significant statistical difference on the primary endpoint versus the placebo group (p less than or equal to 0.0136), with no difference between the two treated groups. In the different groups, use of rescue medication was allowed throughout the period. The adjusted avera
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