|By Business Wire||
|December 1, 2016 07:02 AM EST|
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing CODIT™ (Characterized Oral Desensitization ImmunoTherapy) treatments for life-threatening food allergies, today announced the membership of its Scientific Advisory Board, comprised of internationally recognized food allergy experts.
The Scientific Advisory Board members and their academic affiliations are:
- Dr. Kirsten Beyer, University Hospital Charité, Berlin, Germany
- Dr. A. Wesley Burks, University of North Carolina, Chapel Hill
- Dr. Thomas Casale, University of South Florida, Tampa
- Dr. Jonathan Hourihane, University College Cork, Ireland
- Dr. Stacie Jones, University of Arkansas for Medical Sciences, Little Rock
“As we carry out our Phase 3 PALISADE trial and prepare to start the RAMSES and ARTEMIS trials for AR101 for the treatment of peanut allergy, we are seeking critical peer review of our upcoming development-stage programs from these expert research physicians,” said Daniel Adelman, M.D., Chief Medical Officer of Aimmune. “Their experienced, evidence-based critique will help us in the planning and optimization of forthcoming clinical trials, development strategy and selection of our future therapeutic targets.”
All of the members of Aimmune’s Scientific Advisory Board are investigators in PALISADE, Aimmune’s current Phase 3 clinical trial of AR101 for the treatment of peanut allergy. AR101 is Aimmune’s biologic oral immunotherapy for desensitization of patients with peanut allergy.
“Throughout our clinical trials, we have had the good fortune to work with many dedicated and insightful allergists, and we look forward to continuing to benefit from their knowledge and experience. We are delighted to establish a formal review structure with this group of exceptional researchers, who together have contributed so much to advancing the field of food allergy,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “Our PALISADE trial gave us the opportunity to expand our clinical activity in both the United States and Europe and work directly with Dr. Casale, Dr. Beyer and Dr. Hourihane, each of whom has informed our perspective on critical issues. Dr. Burks and Dr. Jones, of course, have been invaluable guides during not only our current and earlier clinical trials, but also during the foundation of our company itself, as they generously provided data that formed the foundation of our AR101 program. We are truly grateful to have the support of all of these physicians as we pursue our global development programs aimed at improving the lives of people with food allergies.”
Kirsten Beyer, M.D., is a Professor in the Department of Pediatric Pneumology and Immunology at University Hospital Charité in Berlin. Her research experience spans the spectrum of pediatric allergy, with a focus on food allergy. Her interests include food allergy prevention, diagnosis and treatment. Currently, her group is studying the induction of oral tolerance through oral immunotherapy in food-allergic children and the primary prevention of hen’s egg allergy through early hen’s egg feeding, among other studies. She is also part of the EU-funded food allergy project EuroPrevall, studying a European birth cohort of more than 12,000 babies, which will be re-evaluated at school age within the EU-funded project iFAAM. Dr. Beyer qualified as an M.D. at the Free University in Berlin, Germany, and carried out her pediatric training and fellowship at the Humboldt University in Berlin. She was also a visiting scientist at Johns Hopkins University and an Assistant Professor of Pediatrics at Mount Sinai School of Medicine.
A. Wesley Burks, M.D., is Executive Dean for the University of North Carolina School of Medicine as well as the Curnen Distinguished Professor in the Department of Pediatrics. Dr. Burks heads a research team whose work centers on the molecular identification of the allergens in specific foods, a better understanding of the mechanism of adverse food reactions, and the development of treatment for food allergy in pre-clinical and clinical studies. He and his colleagues have several ongoing clinical studies with different types of mucosal immunotherapy. Dr. Burks is also a principal investigator for the Consortium of Food Allergy Research (CoFAR), which was established in July 2005 by the National Institute of Allergy and Infectious Diseases (NIAID) to conduct both observational and clinical studies to answer questions related to food allergies. Dr. Burks earned his medical degree at the University of Arkansas for Medical Sciences, then completed a pediatric residency at the Arkansas Children's Hospital and a fellowship in allergy and immunology at Duke University Medical Center. Dr. Burks is a past Chair and member of the NIH Hypersensitivity, Autoimmune, and Immune-mediated Diseases study section and is Past President of the American Academy of Allergy, Asthma and Immunology, where he served from 2012 to 2013.
Thomas B. Casale, M.D., is a Professor of Medicine and Pediatrics at the College of Medicine at the University of South Florida in Tampa, Florida. Dr. Casale's clinical and basic research interests are directed toward determination and treatment of the pathophysiologic mechanisms involved in asthma and allergic diseases. He is currently the director of clinical and translational research and is actively involved in examining immunomodulators for the treatment of inflammatory disorders. He is also very active in the development of educational programs in allergy and immunology for local, national and international meetings. Dr. Casale earned his medical degree from the Rosalind Franklin University of Medicine and Science, Chicago Medical School, then completed his residency at Baylor College of Medicine and an allergy/immunology fellowship at the National Institutes of Health. He served as President of the American Academy of Allergy, Asthma and Immunology from 2007 to 2008.
Jonathan Hourihane, M.D., is a Professor of Paediatrics and Child Health at University College Cork in Ireland. His research interests focus on the exploration of the link between skin barrier dysfunction and systemic allergic disorders, threshold doses of food allergens, immunomodulation of established allergic responses, prevention of allergic sensitization, and evaluation of quality of life in food allergic children. He is co-principal investigator for the BASELINE birth cohort study, which is tracking more than 2,000 Irish children from soon after conception over several years to study the effects of intrauterine growth restriction, the incidence and prevalence of food allergy and eczema in early childhood, and the incidence and effects of maternal and infant vitamin D status on growth and health. He was Founding Secretary of the Irish Association of Allergy and Immunology and is Founding Chairman of the Irish Food Allergy Network. Dr. Hourihane earned his Bachelor of Medicine (M.B.), Bachelor of Surgery (B.Ch.), and Bachelor of Obstetrics (B.A.O.) degrees at Dublin University, Trinity College and an M.D. from the University of Southampton.
Stacie M. Jones, M.D., is a Professor of Pediatrics and Chief of Allergy and Immunology at the University of Arkansas for Medical Sciences and Arkansas Children's Hospital. She is also a researcher at the Arkansas Children's Research Institute. Her research focuses on both clinical and translational investigation of food allergy and eosinophilic gastrointestinal disorders, as well as on asthma and lung disease. Dr. Jones is also a principal investigator for the Consortium of Food Allergy Research (CoFAR), which was established in July 2005 by the National Institute of Allergy and Infectious Diseases (NIAID) to conduct both observational and clinical studies to answer questions related to food allergies. Dr. Jones earned her medical degree at the University of Arkansas for Medical Sciences and completed her pediatrics residency there and at Arkansas Children's Hospital, followed by a fellowship in Pediatric Allergy and Immunology at Johns Hopkins Hospital.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age and is currently being evaluated in Phase 3 clinical trials in ages 4-55. AR101 is a characterized, regulated, oral biological drug product containing the protein profile found in peanuts. For more information, please see www.aimmune.com.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s expectations for the its Scientific Advisory Board; Aimmune’s expectations for its Phase 3 trials of AR101, including PALISADE, RAMSES and ARTEMIS; Aimmune’s expectations regarding the potential benefits of AR101; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; the company’s ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s clinical trials will not be successful; Aimmune’s dependence on the success of AR101; the company’s reliance on third parties for the manufacture of the company’s product candidates; possible regulatory developments in the United States and foreign countries; and the company’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune's most recent filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
This press release concerns a product that is under clinical investigation and that has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). It is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated.
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