Greer Reports Favorable Results of Phase IIb Clinical Trial of Short Ragweed Sublingual-Oral Immunotherapy at American Academy of Allergy Asthma and Immunology Annual MeetingLENOIR, N.C.--(BUSINESS WIRE)--Mar 14, 2008 - Greer, a leading developer and provider of allergy immunotherapy products, today announced the results of its Phase IIb double-blind placebo-controlled dose response trial for the sublingual-oral immunotherapy (SLIT) administration of its standardized short ragweed pollen extract. According to the study, sublingual-oral immunotherapy was safe and effective in reducing rhinoconjunctivitis and need for anti-allergy medications. Robert Esch, Ph.D., executive vice president of Research and Development at Greer, will present the study findings at the American Academy of Allergy Asthma & Immunology (AAAAI) annual meeting, which will be held March 14-18 in Philadelphia.
In this study, 115 short ragweed pollen-sensitive subjects, ages 19-50 with a history of allergic rhinitis, were randomized into three treatment arms. A rush dose escalation was conducted using Greer's standardized short ragweed pollen extract followed by a pre- and co-seasonal daily treatment course with placebo, medium-dose or high-dose extracts. Efficacy was evaluated using reduction in average daily rhinoconjunctivitis symptoms and anti-allergy medication scores in the treatment groups compared to the placebo group. Safety was monitored through a review of subjects' diaries, self-reports of adverse events and physical exams.
In the active treatment arms, a dose-dependent treatment effect was evident. The medium-dose group achieved a treatment effect of 0.54, and the high-dose group, 0.81, for reduction in rhinoconjunctivitis symptoms. Use of anti-allergy medication during the ragweed pollen season was also reduced in both treatment groups, with a significant effect in the high-dose group.
"We are pleased with the response seen in patients treated with SLIT for short ragweed pollen in this study," says Dr. Esch. "The decrease in symptoms and medication scores provides evidence that the sublingual-oral route of delivering immunotherapy is not only safe, but effective. The results were very similar to the responses seen in traditional allergy injections."
The actively treated groups also showed an increase in ragweed-specific serum IgG, IgG4 and IgA antibody responses after treatment, but the placebo group did not. No serious adverse events were attributed to SLIT, and overall compliance to the treatment regimen was greater than 85 percent. The findings provide evidence that daily maintenance of SLIT doses administered 8-10 weeks prior to and during the ragweed pollen season is safe and effective.
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.
Andrea Moody, 919-244-4356
Posted: March 2008