Greer's Sublingual-Oral Immunotherapy Clinical Trials Support The Safety Of Home Administration Of Allergy Immunotherapy
During the trials, more than 4,500 doses of sublingual-oral immunotherapy were administered over an eight-week treatment course to 91 adult participants ages 18 to 50. All subjects had a history of perennial allergic rhinitis. Approximately 30 percent of study participants also had asthma, which in the past has proven to be a challenging population to treat with allergy immunotherapy.
The maximum tolerable dose (MTD) was determined by administering up to seven incremental, escalating doses 15 minutes apart in a physician's office using a metered dosing device specifically selected for these trials. The MTD was defined as the dose that elicited definite awareness of one or more symptoms that were bothersome but tolerable to the participant. Once the MTD was reached, participants self-administered doses at home and returned to the trial site every two weeks for evaluation and dose-adjustment.
"One of the main goals of our trials was to support the study hypothesis that patients can administer sublingual-oral immunotherapy at home without serious reactions," says Dr. Esch. "The fact that we administered more than 4,500 doses of standardized extract at the MTD, the majority of them at home, through sublingual-oral delivery is a major milestone in allergy immunotherapy treatment in the United States."
The cumulative dose received by patients during the eight-week treatment course was up to 300 times the recommended dose currently used in subcutaneous immunotherapy. The finding illustrated that self-administration of sublingual- oral immunotherapy at home, with proper physician consultation, is generally safe and without serious side effects.
Side effects reported in the study were generally mild to moderate and included oral mucosal itching and irritation; itchy, runny stuffy nose and irritation of the eyes, which were self-resolving or subsided without dose adjustment. Of the more than 4,500 doses delivered, there were no serious reactions directly related to the study medication. Eighty-five percent of subjects completed the trial.
"Greer is pleased to be the first extract manufacturer in the United States to report findings for Phase I safety and dosing trials for standardized allergenic extracts used for sublingual-oral administration of allergy immunotherapy," says John Roby, president and CEO of Greer. "Greer intends to seek FDA approval for the use of sublingual-oral immunotherapy, and this is the first step in achieving that goal."
"The study results found that Greer standardized extracts produced in the United States can be administered without serious reactions, just as many European companies have demonstrated with their extracts," says Dr. Esch. "That information is critical as we begin our next phase of clinical trials." The safety and dosing studies were conducted at the University of North Carolina at Chapel Hill, University of Wisconsin and University of South Florida. Greer is set to commence Phase III parallel, randomized double-blind placebo controlled trials for sublingual-oral immunotherapy later this year.
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 efficacy for standardized products which will be studied through Phase III trials. The company was founded in 1904 and is located in Lenoir, N.C.
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