OLDWICK, N.J., Aug. 20, 2019 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical
company dedicated to intercepting and preventing immune-mediated
diseases, today announced the appointment of Sherron Kell, MD, MPH as Senior Vice President
of Clinical Development. Dr. Kell will lead the PRV-031
(teplizumab) program, including the oversight of the Phase 3
PROTECT study and clinical support of anticipated regulatory
submissions, and will report to Dr. Eleanor
(Leni) Ramos, Chief Medical and Operating Officer. PRV-031
(teplizumab) is an anti-CD3 monoclonal antibody in development for
the interception and prevention of clinical type 1 diabetes
(T1D). PRV-031 (teplizumab) has been granted Breakthrough
Therapy Designation for the prevention or delay of clinical T1D in
individuals at-risk of developing the disease and orphan
designation for newly diagnosed T1D.
"The addition of Sherron further enhances our leadership team
during a transformational time for Provention," stated Ashleigh Palmer, CEO of Provention Bio.
"Sherron's expertise and extensive clinical development experience
will be invaluable as we execute our clinical and regulatory
strategy for PRV-031 (teplizumab) for the interception and
prevention of T1D."
Dr. Ramos added, "We are excited to bring Sherron on board to
lead the PRV-031 program, particularly as we build momentum
following the recent publication of the 'At Risk' data and
subsequent Breakthrough Therapy Designation from the FDA. She
has over 20 years of clinical development, pharmacovigilance/drug
safety and medical affairs experience across multiple therapeutic
areas, including metabolic and endocrine disorders. Her proven
track record in leading late stage clinical trials and supporting
regulatory submissions will provide additional depth and
capabilities as we advance teplizumab closer to patients in
need."
Dr. Kell most recently served as Vice President at Impax
Pharmaceuticals, now Amneal Pharmaceuticals, overseeing Clinical
R&D, Medical Affairs and the Pharmacovigilance and Drug Safety
departments across all stages of clinical studies. Previously, she
was Senior Director, Clinical R&D at Johnson & Johnson, and
Scientific Director at Novartis Pharmaceuticals.
Dr. Kell received her medical degree from the University of Alabama School of Medicine and her
Masters of Public Health degree in Epidemiology at the University of Alabama at Birmingham School of
Public Health. She completed her residency in Internal Medicine at
the Baptist Medical Center in Birmingham,
Alabama, and her fellowship in Geriatric Medicine at the
University of Alabama.
About PRV-031 (teplizumab)
PRV-031, also known as teplizumab, is an anti-CD3 monoclonal
antibody (mAb), which is being developed for the interception and
prevention of type 1 diabetes (T1D). The candidate has been
the subject of multiple clinical studies involving more than 1,000
subjects with more than 800 patients receiving PRV-031 in those
studies. Data published in the New England Journal of
Medicine showed that a single 14-day course of PRV-031
significantly delayed the onset and diagnosis of clinical T1D, as
compared to placebo, by a median of at least 2 years in children
and adults considered to be at high risk of developing clinical
T1D. In previous studies of newly diagnosed patients,
PRV-031 has consistently demonstrated the capability of preserving
beta cell function and reducing the need for exogenous insulin
usage. Provention is currently evaluating PRV-031 in patients newly
diagnosed with clinical T1D (the Phase 3 PROTECT Study); additional
information on the clinical trial is available
at www.clinicaltrials.gov. PRV-031 has been granted
Breakthrough Therapy Designation for the prevention or delay of
clinical type 1 diabetes (T1D) in individuals at-risk of developing
the disease. PRV-031 has been granted orphan designation for
newly diagnosed T1D patients.
About Provention Bio, Inc.
Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage
biopharmaceutical company leveraging a transformational drug
development strategy that is focused on the prevention or
interception of immune-mediated disease. Provention's mission
is to in-license, transform and develop therapeutic candidates
targeting the high morbidity, mortality and escalating costs of
autoimmune and inflammatory diseases including: type 1 diabetes
(T1D), Crohn's disease, celiac disease, and lupus. Provention's
diversified portfolio includes advanced-stage product development
candidates that have undergone clinical testing by other
companies.
Forward Looking Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by the use of
forward-looking words such as "anticipate," "believe," "forecast,"
"estimate," "expect," and "intend," among others. These
forward-looking statements are based on Provention's current
expectations and actual results could differ materially. There are
a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, risks related to
failure to obtain FDA approvals or clearances and noncompliance
with FDA regulations; uncertainties of patent protection and
litigation; limited research and development efforts and dependence
upon third parties; substantial competition; our need for
additional financing and the risks listed under "Risk factors" in
our annual report on Form 10-K for the year ended December 31,
2018 and any subsequent filings with the Securities and
Exchange Commission (SEC). As with any pharmaceutical under
development, there are significant risks in the development,
regulatory approval and commercialization of new products.
Provention does not undertake an obligation to update or revise any
forward-looking statement. The information set forth herein speaks
only as of the date hereof.
Investors:
Sam Martin, Argot Partners
sam@argotpartners.com
212-600-1902
Media:
David Rosen, Argot Partners
David.Rosen@argotpartners.com
212-600-1902
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SOURCE Provention Bio, Inc.