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www.fdanews.com/articles/61081-greer-launches-trial-of-sublingual-oral-immunotherapy

GREER LAUNCHES TRIAL OF SUBLINGUAL-ORAL IMMUNOTHERAPY

July 21, 2006

Greer has announced the initiation of a Phase IIb double-blind placebo-controlled dose-response trial for sublingual-oral immunotherapy of its standardized short ragweed extract in adults with short ragweed pollen allergy. Patient recruitment and screening has begun at four allergy clinics in the United States.

The trial will involve short ragweed-allergic adult patients, all having a history of moderate to severe allergic rhinoconjunctivitis for at least two years. Patients with mild, intermittent asthma symptoms attributable to short ragweed also will be included in the trial. The patients will self-administer the placebo or short ragweed extract through a metered dose delivery device and will hold the extract under their tongue for one to two minutes before swallowing.

Sublingual-oral immunotherapy is an alternative to traditional allergy injections. Greer's oral immunotherapy program utilizes the same liquid allergenic extract used in allergy injections, but it is administered under the tongue in drops.