Greer to Launch Phase I Trial of Grass Pollen Allergy
Posted on: Tuesday, 4 December 2007, 12:00 CST
Greer has received FDA clearance to launch a safety and dosing study using its standardized Timothy grass extract in patients who discontinued subcutaneous immunotherapy injections either due to adverse reactions or intolerability.
The Phase I trial will evaluate the safety and maximum tolerable dose of sublingual-oral immunotherapy in patients with confirmed Timothy grass pollen allergy and history of at least one systemic reaction to subcutaneous immunotherapy.
Initially, participants in the study must be 18-50 years of age, with subsequent enrollees to include children 12 years of age and older. Participants must have a documented history of both Timothy grass allergic rhinoconjunctivitis, and at least one systemic reaction to subcutaneous allergy injections. Patients with mild asthma are eligible.
Greer's Research and Development strategy is to conduct clinical trials using the company's standardized allergenic extracts in an effort to bring an FDA-approved sublingual-oral immunotherapy treatment to the US.
Robert Esch, vice president of research and development at Greer, said: "This study will evaluate the safety of sublingual-oral immunotherapy in patients who cannot tolerate allergy injections."
Source: Datamonitor
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