Healthcare Industry News:  allergic rhinitis 

Biopharmaceuticals

 News Release - March 14, 2008

Greer Launches Phase III Trial to Study Efficacy of Sublingual-Oral Immunotherapy in Patients with Allergic Rhinoconjunctivitis

Multi-Center Trial to Evaluate the Efficacy of the Sublingual-Oral Administration of Greer's Standardized Short Ragweed Extract

LENOIR, N.C.--(HSMN NewsFeed)--Greer, a leading developer and provider of allergy immunotherapy products and services, announced today the launch of a Phase III randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy of sublingual-oral immunotherapy (SLIT) in adults with allergic rhinoconjunctivitis caused by short ragweed pollen. Greer is the first U.S. allergy company to initiate a Phase III trial for the oral administration of liquid standardized allergenic extracts.

Sublingual-oral immunotherapy (SLIT) is widely accepted as a safe, effective treatment for allergic rhinitis in Europe. However, the allergenic extracts used for SLIT in Europe differ from the allergen products expected to be approved in the United States. The aim of the Phase III trial is to support changes in labeling for Greer’s currently licensed short ragweed allergenic extract.

“Our primary objective is to demonstrate that SLIT using short ragweed extract prior to and during ragweed season reduces allergy symptoms and the need for anti-allergy medications,” says Robert Esch, Ph.D., Greer Executive Vice President of Research and Development. “In addition to the symptom reduction scores, we will also conduct blood tests to determine if SLIT increases ragweed-specific antibody levels which would signal the presence of the same immunological markers that we see with traditional injection immunotherapy.”

The trial is being conducted at 30 allergy specialty centers across the United States and will enroll approximately 458 patients. Participants must be ages 18-50 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 are eligible. The study will last approximately seven months.

“This trial is pivotal in Greer’s efforts to bring SLIT to the United States,” says John Roby, Greer President and CEO. “Much of the allergy specialty community’s hesitation to embrace sublingual-oral immunotherapy has stemmed from the lack of data evaluating U.S. licensed allergenic extracts and FDA approval. Our hope is that this study will clearly show the role SLIT can play in improving allergy care and position Greer as a leader in bringing this delivery method to the United States.”

Greer recently completed a Phase IIb trial for short ragweed involving 115 adults with documented short ragweed sensitivity. As reported in the study, participants receiving SLIT short ragweed extract documented a reduction in allergy symptoms and need for anti-allergy medications during ragweed season. The reduction was most significant in the high-dose groups. The trial findings will be presented at the 2008 American Academy of Allergy Asthma and Immunology Annual Meeting in Philadelphia.

About Greer

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.


Source: Greer Laboratories

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