June 26, 2008
Greer Completes Enrollment for Pivotal Phase III Clinical Trial Evaluating the Efficacy of Sublingual-Oral Immunotherapy for Treating Short Ragweed Allergies
Greer, a leading developer and provider of allergy immunotherapy products and services, has completed enrollment for its pivotal Phase III clinical trial designed to study the efficacy of sublingual-oral immunotherapy (SLIT) as a treatment for adults with allergic rhinoconjunctivitis caused by short ragweed pollen. It is estimated that 30 million Americans are allergic to short ragweed pollen, making it one of the most common allergens.
Between March and June, 556 patients were screened for the randomized, double-blind, placebo-controlled trial, of which 430 were enrolled. The participants will be observed at 31 clinical sites across the country. The trial will last approximately seven months, ending in mid-October to coincide with the completion of the short ragweed pollen season.
"We are very pleased with enrollment for the study," says Robert Esch, Ph.D., Greer Executive Vice President of Research and Development. "This study is significant because it is the first large Phase III trial conducted in the United States for the sublingual-oral administration of liquid allergenic extracts. It is vital to Greer's efforts to bring an FDA-approved sublingual-oral immunotherapy treatment to the United States."
Greer's sublingual-oral immunotherapy studies are aimed at supporting the submission of a request for a directions for use (DFU) label change for its standardized short ragweed pollen extract. Greer's Phase I study supported the safety of the home administration of SLIT. A subsequent double-blind, placebo-controlled Phase IIb trial involving 115 adults with short ragweed sensitivity found that participants receiving SLIT short ragweed pollen extract documented a reduction in allergy symptoms and need for anti-allergy medications during ragweed season.
"There is a lot of interest in SLIT and this study throughout the allergy community," says Michael E. Ruff, M.D., a board certified allergist in Dallas, and one of the clinical investigators. "Our goal is that the trial will provide the scientific data needed to better determine the role SLIT can play in allergy care here in the United States."
The treatment course will consist of daily, self-administered doses of Greer's standardized short ragweed pollen extract or placebo using a metered dosing device developed specifically for the studies. Participants range in ages from 18-55 and have a history of moderate to severe allergic rhinoconjunctivitis attributable to short ragweed pollen for at least two years. Patients with a history of mild intermittent asthma were also selected.
Greer is a leading developer and provider of allergy immunotherapy products and services for treating humans and animals. Greer's expert 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 oral administration of allergy immunotherapy. Greer's goal is to establish the efficacy of standardized products for oral administration through clinical trials. The company was founded in 1904 and is located in Lenoir, N.C. For more information, visit www.greerlabs.com.