LENOIR, NC (January 10, 2005) — Greer Laboratories, Inc., a provider of allergy immunotherapy products and services, has received Food & Drug Administration (FDA) approval to begin Phase I safety and dosing studies focused on sublingual-oral administration of dust mite allergenic extracts.
Dust mite is one of the most prevalent allergens. Of the roughly 50 million people who suffer from allergies in the United States, approximately 15 percent are sensitive to the dust mite allergens. It is estimated that an additional 10 to 15 million people remain undiagnosed.
“The approval to move forward with our safety and dosing trials marks a major milestone for Greer’s R&D sublingual clinical program,” states Bob Esch, Ph.D, Greer chief scientist.
The World Health Organization now classifies allergy as the fourth most important disease in the world and estimates that by 2010, approximately 40 percent to 50 percent of the world’s population could be affected.
In the United States, approximately 3 million of the 50 million allergy sufferers are treated with predominantly subcutaneous immunotherapy. Sublingual immunotherapy is delivered via the patient’s oral mucosa.
“Sublingual immunotherapy is of interest to some allergists because it offers a potential alternative for patients who may not be treated with injection immunotherapy,” stated Dr. Spencer Atwater, former president of the Joint Council of Allergy, Asthma & Immunology