Texas Children's Hospital launches immunotherapy study

HOUSTON - (Aug. 28, 2014) - For children with food allergies, a trace amount of a substance can trigger deadly anaphylaxis within minutes of ingestion - the fear of which can be life altering for many families. To give hope to these patients and their families, researchers at Texas Children's Hospital and Baylor College of Medicine are embarking on a landmark peanut immunotherapy trial, using a process known as desensitization where patients swallow tiny, increasing amounts of peanut over time. For more information about Texas Children's Hospital's Immunology, Allergy and Rheumatology Department, please visit texaschildrens.org

The research team, led by Dr. Carla Davis, a specialist in the Pediatric Medicine, Immunology, Allergy and Rheumatology Department at Texas Children's and assistant professor of pediatrics at Baylor, begin enrolling children with peanut allergies in the trial this month. The study will investigate the ability of peanut allergic children to take peanut flour, the mechanism by which the body develops tolerance, and measure the effect of viral infections. The goal of the trial is to find a standard of care that may lower the risk of severe allergic reactions in patients and eventually cease the allergy completely.

In Europe, a recent oral immunization trail (OIT) showed promise, and in the United States the Consortium for Food Allergy Research and Stanford University are both conducting similar studies. Presently, desensitization is not the standard of care and no study has determined the mechanism by which the body develops a tolerance. Davis and her team plan to monitor how the immunotherapy works and why, as well as develop systems to accurately identify patients who are good candidates for immunotherapy.

"No other immunotherapy trial has used the state of the art laboratory testing of immune cells to improve the process of desensitization that Texas Children's has," said Davis. "We believe the information gained from this trial will help make the process of desensitization faster and more efficient in the future."

Davis and her team will collaborate with the Center for Cell and Gene Therapy and Texas Children's Center for Human Immunobiology, directed by Dr. Jordan Orange who is also chief of Allergy, Immunology and Rheumatology at Texas Children's and professor of pediatrics, pathology and immunology at Baylor, to evaluate more than 25 markers of cells called lymphocytes, which are central to controlling immune responses. Patients will have blood drawn and these markers will be evaluated by a process called flow cytometry. The markers will provide insight into how the immune system works to cause food allergies.

"Our study evaluates clinical measures, but in conjunction with the lymphocyte markers that will give us a better way to treat and potentially cure food allergy. This will also help us identify the best kind of patient for this treatment," said Davis.

One in 13 U.S. children has a food allergy according to recent data from the national organization FARE (Food Allergy Research and Education). This reflects a nearly 50 percent increase in childhood food allergies between 1997 and 2011, leading to $25 billion per year in related health costs in treatment and diagnosis. Children can be allergic to any type of food, but eight foods account for nearly 90 percent of all allergic reactions to food in the U.S., with peanuts being the food that is most associated with life threatening food related anaphylaxis. More than 400,000 school-aged children in the U.S. have this allergy, according to the American College of Allergy, Asthma and Immunology.

"We chose this food (peanuts) to make the largest difference in safety for our patients," said Davis.

Texas Children's is the first center in the southwest region with approval from the Food and Drug Administration to dispense peanut flour as an investigational new drug. The major funding of this study has been provided by the Wareing Family and Scurlock Foundation, with additional generous support provided by families in the Texas Children's Hospital Food Allergy Advisory Group as well as gifts provided by concerned members of the greater Houston Community. Initially, 20 patients will be enrolled, with the potential to enroll hundreds more over the next three years, with the help of expanded funding.

About Texas Children’s Hospital

Texas Children’s Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children’s hospital in Texas, and among the top in the nation, Texas Children’s has garnered widespread recognition for its expertise and breakthroughs in pediatric and women’s health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Center for pediatric research; Texas Children’s Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children’s Hospital West Campus, a community hospital in suburban West Houston; and Texas Children’s Hospital The Woodlands, a second community hospital planned to open in 2017. The organization also created the nation’s first HMO for children, has the largest pediatric primary care network in the country and a global health program that’s channeling care to children and women all over the world. Texas Children’s Hospital is affiliated with Baylor College of Medicine. For more information, go to www.texaschildrens.org. Get the latest news by visiting the online newsroom and Twitter at twitter.com/texaschildrens.