Greer Announces Safety And Dosing Study Evaluating Sublingual-Oral Immunotherapy In Patients With History Of Adverse Reactions To Allergy Injections

Main Category: Allergy
Also Included In: Immune System / Vaccines
Article Date: 05 Dec 2007 - 4:00 PDT

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Greer, a leading developer and provider of allergy immunotherapy products, 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. The study is being conducted at Allergy Partners in Asheville, N.C. and William McCann, M.D. will serve as principal investigator.

"This study will evaluate the safety of sublingual-oral immunotherapy in patients who cannot tolerate allergy injections," says Dr. Robert Esch, Vice President of Research and Development for Greer. "Greer's goal is to continue to investigate the safety of sublingual-oral immunotherapy as we determine the role sublingual immunotherapy can play in improving allergy care."

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. The study began in November 2007 and participation lasts approximately two weeks.

Sublingual-oral immunotherapy is an alternative to traditional allergy injections and is routinely used throughout Europe and other parts of the world. 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 United States.

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 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.

About Greer Research & Development

Greer's Research and Development Team is devoted to making substantial contributions to the advancement of allergy immunotherapy. By collaborating with allergy specialists, we will share significant innovations for treating both human and animal allergy sufferers.

http://www.greerlabs.com