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Greer Announces Launch of Phase IIB Clinical Trials for Sublingual-Oral Immunotherapy for Short Ragweed Allergy; Multi-Center Study to Further Establish the Safety and Preliminary Efficacy of Sublingual-Oral Immunotherapy Using Greer Extracts.

LENOIR, N.C. -- Greer, a leading developer and provider of allergy immunotherapy products, announced the initiation of a Phase IIB double-blind placebo controlled dose response trial for sublingual-oral immunotherapy of its standardized short ragweed extract after receiving clearance of the study protocol from the FDA. The Phase IIB trials will evaluate the safety and efficacy of sublingual-oral immunotherapy in adults with short ragweed pollen allergy. Patient recruitment and screening has begun at four allergy specialty clinics in the United States.

"We chose to study short ragweed because it is one of the most prevalent forms of pollen allergy in the United States," says Dr. Bob Esch, Vice President of Research and Development for Greer. "The majority of Americans with seasonal allergic rhinitis are sensitized to short ragweed pollen, so this patient population will be representative of pollen-allergic patients commonly seen in allergy offices. The results of this study will provide more data on the safety of sublingual-oral administration of allergens and also will give us data on its efficacy."

Patients who meet study criteria to participate in the trial will be randomized to placebo or one of two treatment dosage groups. The patients will self-administer the placebo or short ragweed extract through a metered dose delivery device. They will hold the extract under their tongue for one to two minutes before swallowing.

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. Asthmatic patients have proved to be a challenging population to treat with allergy immunotherapy in the past.

"The launch of our Phase IIB clinical trial marks a major step in Greer's business plan to bring an FDA-approved sublingual product to the United States," says John Roby, President and CEO of Greer. "Our goal for sublingual-oral immunotherapy is to provide an additional treatment option for allergy specialists to offer their patients. Though allergy injections are beneficial, a large number of patients decline immunotherapy because they don't want shots. We believe that more patients would choose immunotherapy if they had additional treatment options such as sublingual-oral immunotherapy."

Greer announced findings of its Phase I safety and dosing trials of standardized dust mite, short ragweed, Timothy grass and cat hair allergenic extracts at the AAAAI meeting in March 2006.

Sublingual-oral immunotherapy is an alternative to traditional allergy injections and is routinely used throughout Europe and other parts of the world. Greer's oral immunotherapy program utilizes the same liquid allergenic extract used in allergy injections, but it is administered under the tongue in drops.

About Greer:

Greer is a leading developer and provider of allergy immunotherapy products and services for treating humans and animals. Greer's highly skilled scientists provide technical support for customers by continuing to focus on improving the lives of allergic patients. Greer's clinical development programs are focused on expanding the use of immunotherapy through an expansive Research and Development program. The company was founded in 1904 and is located in Lenoir, N.C. To learn more about Greer, visit www.greerlabs.com.
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Publication:Business Wire
Date:Jul 20, 2006
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