Greer's Sublingual-Oral Immunotherapy Clinical Trials Supporting the Safety of Home-Administered Treatment Published in the Annals of Allergy, Asthma and Immunology
Sublingual-oral immunotherapy (SLIT) is widely accepted as a safe, effective treatment for allergic rhinitis in Europe, and is now gaining popularity as a potential delivery mechanism in the United States. However, the allergenic extracts used for SLIT in Europe differ from the allergen products expected to be approved in the United States.
"These were the first clinical trials evaluating the safety and tolerability of U.S. standardized allergenic extracts for the sublingual route of administration," says Dr. Esch. "This was a critical first step in establishing the safety and efficacy of SLIT using our standardized allergenic extracts. The results of these studies were used to design our Phase II and III safety and efficacy trials."
During the studies, more than 4,500 sublingual doses were administered to 91 adult participants with seasonal or perennial allergic rhinoconjunctivitis. 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.
Patients received a single-session dose escalation to estimate their maximum tolerable dose (MTD) followed by an 8-week open-label daily course of SLIT using a metered dosing device specifically designed for the trials. The subjects were able to tolerate, without serious side effects, up to 300 times the cumulative doses currently used in subcutaneous immunotherapy.
Seventy-seven percent of the patients completed the studies. Ninety-five percent of the reported side effects were rated mild or moderate. Most were related to nasal and oral mucosal irritation and subsided without treatment. There were no life-threatening side effects. Investigators concluded that daily sublingual-oral dosing of standardized allergenic extracts at maximum tolerable doses was safe and generally well-tolerated.
"The study findings mirror the long-standing safety data from European SLIT studies," says Robert Bush, M.D., Professor of Medicine, University of Wisconsin-Madison and study investigator. "Now that we have evidence that SLIT using U.S. allergenic extracts is safe, we can use this data in larger planned studies aimed at documenting its efficacy for a variety of allergens."
Greer is currently recruiting participants for a large Phase III study involving the sublingual-oral administration of its standardized ragweed extract. More information can be found at www.ClinicalTrials.gov. The results of the Phase I trials were originally reported at the 2006 American Academy of Allergy Asthma and Immunology (AAAAI) annual meeting. To request reprints of the paper, please email innovation@greerlabs.com.
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.
Contact
For Greer
Andrea Moody, 919-244-4356
andrea.moody@fleishman.com
Posted: March 2008
