Cincinnati Children’s Researchers Publish Positive Findings From Clinical Study Of Investigational Treatment For Debilitating Allergic Disorder

Cincinnati Children's Hospital Medical Centre, a recognized leader in paediatric research dedicated to changing the outcomes for children, today announced the publication of positive results from a phase 1/2 clinical trial evaluating mepolizumab, a humanized antibody to interleukin 5 (IL-5), for the treatment of eosinophilic oesophagitis (EE). EE is an allergic inflammatory reaction characterized by the accumulation of large numbers of eosinophils (a type of white blood cell associated with allergic reactions) in the oesophagus that leads to vomiting and difficulty in swallowing.

"Previous results suggested a key role for interleukin 5 in the accumulation of eosinophils in the oesophagus and provided a strong rationale for evaluating an anti IL5 antibody as a potential therapy for EE," said Marc Rothenberg M.D., Ph.D., director of the Division of Allergy and Immunology at Cincinnati Children's Hospital Medical College. "With support of the CCHMC Translational Research Office, this study provided a strong proof of concept for the use of mepolizumab. This data has fuelled the pharmaceutical industry to expand this clinical experience with the goal of providing patients with a meaningful and effective treatment option." The paper, published in the December issue of the Journal of Allergy and Immunology, describes positive results from an open-label phase I/2 study evaluating the safety and efficacy of mepolizumab in four adult patients with EE who had long term difficulty in swallowing and oesophageal narrowing caused by chronic inflammation. Patients received 3 monthly infusions of mepolizumab without change in their current therapy and were monitored for 28 weeks.At the conclusion of the study, analysis showed statistically significant reductions in several key indicators of disease including marked decreases in eosinophils in the peripheral blood and in the oesophagus. In addition endoscopic examination of the oesophagus showed improvements in three out of four patients. The treatment was generally well-tolerated, and all patients reported a better clinical outcome and improved quality of life."Cincinnati Children's has long been at the forefront of research into eosinophilic disorders and its commitment was recently underscored by the establishment of the Cincinnati Centre for Eosinophilic Disorders," said Ellyn Kodroff, President, CURED: Campaign Urging Research for Eosinophilic Disorders. "Clinical results like this provide important hope for relief from the horrific effects of this condition for patients and their families."EE is part of a series of chronic and debilitating gastrointestinal disorders associated with allergies that are characterized by elevated levels of eosinophils that attach to the intestinal tract leading to abdominal pain, nausea, vomiting and difficulty swallowing. Patients suffering from these disorders frequently must adhere to a strict diet or acquire nutrients via a feeding tube directly inserted into the stomach; and many endure nausea, abdominal pain and vomiting after every meal. Newly recognized as a disease, data shows a dramatic increase in the diagnosis of EE. It is estimated that at least one in 1,500 people suffer from some form of the disorder.Allergic disorders are a major public health problem, affecting 50 million people in the United States. Nine million children under 18 have been diagnosed with asthma, and asthma rates in children under the age of five increased more than 160 percent from 1980-1994.(Source: Cincinnati Children's Hospital Medical Centre : January 2007.)