— Five Leading Food Allergy Researchers and
Clinicians Form Distinguished Board —
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.
Forward-Looking Statements
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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version on businesswire.com: http://www.businesswire.com/news/home/20161201005432/en/
Aimmune Therapeutics, Inc.InvestorsLaura Hansen, Ph.D.,
650-396-3814lhansen@aimmune.comorMediaStephanie Yao,
650-351-6479syao@aimmune.com
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