Transforming the lives of our patients and their families through innovative science and compassionate care.
Phase 3 OUtMATCH Clinical Trial Demonstrates That Xolair is Effective for Treating Food Allergy
The results of the NIAID funded phase 3 OUtMATCH clinical trial were published online Feb. 25 in the New England Journal of Medicine. The findings suggest that regular use of the drug, omalizumab, could protect people from mild or severe allergic reactions if they accidentally eat a small amount of a food they are allergic to. The study included 177 children, as young as 1 year of age, and studied peanut, milk, egg, cashew, walnut, hazelnut, and wheat. Most food allergic individuals are allergic to more than one food and omalizumab has the potential for simultaneous protection against multiple allergens. Patients randomized to omalizumab had protection up to 1044mg (amounts higher than that encountered in accidental exposures) to1 food (80%), 2 foods (69%), and 3 foods (47%). Omalizumab was safe and well tolerated with known common side effects of pain or irritation at the site of the shot and fever. Thanks to all our patients and families at the Center and across the 9 other sites that participated and are participating in this study – you are changing the field for many more patients like you! Stage 2 and 3 of the OUtMATCH study are still ongoing and will help answer the many questions that still remain.
FDA Approves the Use of Xolair for Food Allergy
After reviewing data on the safety and efficacy of Xolair (omalizumab) for the treatment of food allergy in the OUtMATCH clinical trial, along with data from Phase 1 and 2 studies completed at Stanford and other sites, the FDA has approved the use of Xolair for the treatment of food allergy. Xolair (omalizumab) is an inhibitory antibody that targets immunoglobulin E, one of the primary drivers of food allergy. It was first approved by the FDA for the treatment of moderate to severe persistent allergic asthma in 2003 and is typically given as a shot every 2-4 weeks. The NIAID funded OUtMATCH clinical trial demonstrated that omalizumab provides protection against accidental ingestion for multiple different foods including peanut, milk, egg, wheat, cashew, hazelnut, and walnut. The FDA approval of Xolair for food allergy is a big step forward for our food allergy patients. Individuals taking Xolair are still recommended to avoid allergenic foods, however as Dr. Sharon Chinthrajah, Director of the Sean N. Parker Center for Allergy & Asthma Research at Stanford University explains “This offers a layer of protection when they go out, to live their life as normally as possible”.
Stanford University and the London School of Hygiene & Tropical Medicine team up to create new Post-doctoral Fellowship in Planetary Health
Stanford University’s Center for Innovation in Global Health and the Stanford Woods Institute for the Environment, together with the London School of Hygiene & Tropical Medicine‘s Centre on Climate Change & Planetary Health, have joined forces to create a new Post-doctoral Fellowship in Planetary Health to support early-career researchers tackling pressing questions in this emerging field.
Planetary health is the health of human civilization and the state of the natural systems on which it depends. Urgent threats to human health arise from the impacts of man-made climate and environmental change including air pollution and the loss of food pollinating insect species. These threats disproportionately affect low-resource communities where people suffer dangerous consequences such as heat stress, reduced access to safe water and undernutrition.
Research in the field of planetary health is developing fast and requires novel approaches that focus on developing evidence for policy and real-world interventions. The Institutes driving this new Fellowship in Planetary Health are leaders in the field, and their collective expertise brings together more than 100 scientists active in aspects of planetary health and policy solutions.
While fellowships are typically hosted in one institution, this partnership gives researchers a unique opportunity to engage in a range of disciplines and pursue ground-breaking research. The Planetary Health Fellows will spend time with senior faculty mentors at both LSHTM and Stanford. Fellows will also engage in research with local partners in countries such as Bangladesh, The Gambia, India, Uganda and Zimbabwe.
“Running a Fellowship program across LSHTM and Stanford will help us tackle some of the biggest questions in human and planetary health,” said Dr. Michele Barry, Stanford’s Senior Associate Dean of Global Health. “I would love to see this as a way of expanding planetary health research capacity among early-career scientists from low and middle-income countries, and I hope this Fellowship will help inspire new ways of thinking that will develop a resilient and sustainable planet.”
“This joint initiative emphasizes planetary health as an area of urgent and critical investigation,” said Professor Alan Dangour, Director for the Centre on Climate Change & Planetary Health at LSHTM. “As well as inspiring planetary health researchers to think in new ways, the research will help us generate high-quality evidence-based solutions for the health of people and the planet.”
Funding comes from the Gordon and Betty Moore Foundation, the Sean N. Parker Center for Allergy and Asthma Research at Stanford University, and Bob and Kathy Burke.
The Fellowship program is open to researchers from anywhere in the world who have completed their doctoral degree within the past three years . The call for applications for the Fellowship in Planetary Health will open in June 2020 and the two-year Fellowship will begin in late 2020 / early 2021.
Groundbreaking Phase 3 trial of oral immunotherapy in children and adolescents who were highly allergic to peanut
- Results from a phase 3 clinical trial of AR101, a highly characterized, pharmaceutical-grade, peanut OIT formulation are now published in the New England Journal of Medicine. AR101, developed by Aimmune Therapeutics, is designed to provide consistent dosing of the major allergenic peanut proteins (Ara h1, Ara h2, and Ara h6). The Sean N. Parker Center for Allergy and Asthma Research at Stanford University was one of the Centers at which the study was performed and this study builds on the phase 1 and 2 studies we and others have done around the world. Children and adolescents who were included in the study were highly allergic to peanuts. After one year of therapy, 67% of those treated with AR101 tolerated approximately 2 peanuts without dose-limiting symptoms compared to 4% treated with placebo. Patients also had lower symptom severity during peanut exposure at the exit food challenge than placebo.
- Read more in the New York Times and on CNN.
The Sean N. Parker Center for Allergy and Asthma Research at Stanford University was honored to host the 2nd Annual State of the Center Forum
THE SEAN N. PARKER CENTER FOR ALLERGY AND ASTHMA RESEARCH AT STANFORD UNIVERSITY IS DESIGNATED A WORLD ALLERGY ORGANIZATION CENTER OF EXCELLENCE
In November 2017, the World Allergy Organization (WAO) designated the Sean N. Parker Center for Allergy and Asthma Research Center at Stanford University a WAO Center of Excellence.
The World Allergy Organization (WAO) is an international umbrella organization whose members consist of 97 regional and national allergology and clinical immunology societies from around the world. By collaborating with member societies, WAO provides direct educational outreach programs, symposia and lectureships to members in nearly 100 countries around the globe
A WAO Center of Excellence distinction intensifies and accelerates multidisciplinary scientific and clinical innovation, education, and advocacy worldwide providing excellence in education, research, training to various stakeholders in allergy, asthma and clinical immunology.
Julia and David Koch Make Visionary $10 Million Gift to Establish New Clinical Research Unit for Allergy and Asthma at Lucile Packard Children’s Hospital Stanford and the Sean N. Parker Center for Allergy and Asthma Research at Stanford University
On February 15, 2017, Julia and David Koch announced a generous gift of $10 million to establish a new unit at Lucile Packard Children’s Hospital Stanford for clinical research. The unit will operate within the Sean N. Parker Center for Allergy and Asthma Research at Stanford University, which is home to the groundbreaking allergy and asthma clinical trials led by Kari Nadeau, MD, PhD.
Nadeau directs the Sean N. Parker Center for Allergy and Asthma Research, one of the world’s first coordinated efforts to combine lab research, clinical research, and compassionate patient care across all types of allergies. While Nadeau conducts lab research on the Stanford University campus, she currently conducts clinical research off campus at a Packard Children’s-licensed unit within El Camino Hospital in Mountain View.
Thanks to the Kochs’ generous gift, Nadeau and her team will expand their clinical research to a redesigned unit within Lucile Packard Children’s Hospital Stanford in 2018. Packard Children’s is currently nearing completion on a major expansion which will subsequently free up space for Nadeau’s research. With its location on the Stanford campus, the new site for clinical trials will enable Nadeau’s team to expand research to better understand the underlying cause of allergies and to develop a lasting cure. It will also bring them within walking distance of Nadeau’s research lab and other physicians and researchers working together at Stanford to advance allergy and asthma research.
"We made this gift with the goal of bringing better and safer treatments to more children and adults suffering from dangerous allergies," said Julia F. Koch, whose family has experienced firsthand the anxiety of living with food allergies, as well as the life-changing effects of a clinical trial to safely desensitize the allergies. "Through this gift, we hope to advance innovative research and allow more individuals and families to enjoy fuller lives."
“Mr. and Mrs. Koch’s thoughtful investment will have a tremendous impact on the care and treatment we provide for children and families with allergies and asthma,” says Nadeau. “Children and families with food allergies often live in constant fear of life-threatening reactions. We are determined to use innovative research and provide compassionate care to move the science forward in a transformative way to ensure a safer future. I am tremendously grateful to Mr. and Mrs. Koch for their gift to establish a new clinic, which will play an integral role in advancing this work at the Sean N. Parker Center for Allergy and Asthma Research. Together, we will make a difference not only for those participating in clinical trials at Lucile Packard Children’s Hospital Stanford, but for all individuals with allergies who may one day benefit from research toward better, safer, and lasting therapies.”
Allergies and asthma are on the rise around the world, including in the United States. Allergies occur in all ages and can range from allergic conjunctivitis, allergic rhinitis, allergic asthma, and allergic gastrointestinal disease to drug allergies and food allergies. Severe food allergies are a growing epidemic, with rates having doubled in the last decade. About one in three Americans suffer from some form of allergy, and doctor-diagnosed food allergies affect one in 12 American children under the age of 21 and one in about 50 adults. Of those individuals with a food allergy, approximately 25 percent will have a near-fatal anaphylactic reaction at some point in their lives. It is estimated that $25 billion is spent annually on reactive food allergy care.
Nadeau, who is also the Naddisy Foundation Professor of Medicine and Pediatrics at Stanford University School of Medicine, developed the first combination multi-food-allergy therapy for patients with more than one food allergy. The new unit at Packard Children’s will put her team within closer proximity to colleagues in immunology, gastroenterology, otolaryngology, chemistry, bioengineering, pathology, pulmonology, and genetics at Stanford University who are contributing to this important collaborative work.
For more information, contact Jennifer Yuan, Lucile Packard Foundation for Children’s Health
National Academies of Sciences, Engineering and Medicine release comprehensive report on Food Allergy
The National Academies of Sciences, Engineering, and Medicine convened an expert, ad hoc committee to examine critical issues related to food allergy. The resulting report, released on November 30, 2016, Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy, collects and evaluates the scientific evidence on the prevalence, origins, diagnosis, prevention, and management of food allergy and makes recommendations to policy makers, industry leaders, and others to bring about a safe environment for those with food allergy.
Following is a statement by Dr. Stephen Galli, the Mary Hewitt Loveless, M.D. Professor in the Stanford School of Medicine and Professor of Pathology and of Microbiology and Immunology, who served as a member of the Institute of Medicine committee that wrote this report.
It was a privilege and honor to serve on this committee, and to work in producing the report with the other members of the committee, the dedicated and effective national academies staff, and the many private and federal sponsors of this important effort.
As described in the brief summary of the report that was released today, and as presented in substantial detail in the report itself, the committee concluded that the time is now to undertake a number of measures that, if enacted successfully, promise to improve markedly the quality of life of those suffering from food allergies. Succeeding in this effort will require the prompt and responsive cooperation of many stakeholders, including those federal and state agencies whose thoughtful work will be required to effect these changes. I encourage all those who are interested in the problem of food allergy to read the report and to do their part in encouraging the rapid implementation of the committee's recommendations.
As important as implementing the report's recommendations will be in addressing this serious problem, finally succeeding in finding ways to effectively treat, or ideally to prevent the occurrence, of food allergies will require innovative research to advance our understanding of the origins of this disorder, and to devise better ways to prevent or treat it. I anticipate that, with the visionary leadership of Kari Nadeau, the Sean N. Parker Center for Allergy & Asthma Research at Stanford will continue to contribute importantly to the world-wide efforts, by talented investigators at many institutions, to bring relief to those suffering from this terrible disorder.
Hartman Family Foundation Challenge grant Matched
We met our match! We are thrilled to announce that we have raised $1.2 million to meet our challenge grant from the Hartman Family Foundation. Through the generous 1-to-1 match from Kim and Alan Hartman's Foundation and so many other generous donors, we raised a total of $2.4 million to directly support this major step to making a food allergy “vaccine” a reality.
Stay tuned for updates about this groundbreaking study to test an approach called peptide “vaccine” immunotherapy. Similar to a tuberculosis test, the food allergy “vaccine” would go under the skin to stimulate a specific set of immune cells and permanently reduce or suppress allergic reactions.
“This could be a breakthrough for our field and we are grateful to the Hartman Foundation for making it possible through their gift,” said Dr. Kari Nadeau, Director of the Sean N. Parker Center for Allergy & Asthma Research at Stanford University.
94% of Center funding is provided by philanthropy. Ongoing support helps patients and families everyday by advancing the science and research for groundbreaking clinical trials, educating and disseminating protocol across the nation, building infrastructure for the Center, and so much more. To learn more about our important funding priorities, contact Lindsey Hincks.
Research changes lives! When you join the FARE Patient Registry and answer survey questions about your food allergy experiences, you’re taking an important step that benefits both you and the entire food allergy community.
Your answers will help food allergy researchers understand the disease and search for new treatments.
You’ll have the option to learn about clinical trials and connect with researchers.
Stanford Allergy is proud to be a part of the FARE Clinical Network conducting novel research on treatments, diagnostics, prevention, and improvements to care.
Click HERE to get started!
NEW! Annual Update on Allergies & Asthma 2022
The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is an affiliate of the Institute for Immunity, Transplantation and Infection (ITI), Stanford School of Medicine. Learn more about ITI.