OLDWICK, N.J., Nov. 28, 2018 /PRNewswire/ --
Provention Bio, Inc. (Nasdaq:PRVB), a clinical-stage
biopharmaceutical company dedicated to sourcing, developing and
commercializing novel therapeutics aimed at intercepting and
preventing immune-mediated diseases, announced today that the
company has joined the Critical Path Institute's Type 1 Diabetes
(T1D) Consortium. Founded in March
2017 by the Critical Path Institute (C-Path), C-Path's T1D
Consortium is focused on understanding the scientific and
regulatory expectations associated with the application of
biomarkers used to optimize clinical trial designs in this
disease. Currently, the T1D Consortium is actively engaged in
the regulatory qualification of islet autoantibodies as
susceptibility/risk biomarkers to be used as enrichment criteria in
the development of therapies for the treatment, and ultimately the
prevention, of T1D. Current membership includes Janssen Research
& Development, LLC (Janssen), JDRF International (JDRF), Novo
Nordisk, Sanofi and The Leona M. and Harry B. Helmsley Charitable
Trust.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
"We are extremely honored to be granted membership into the T1D
Consortium and welcome the opportunity to work alongside such an
esteemed group of researchers and companies, including our current
collaborators, Janssen and JDRF, in pursuit of the ultimate goal of
preventing or intercepting T1D," said Ashleigh Palmer, Provention Bio's Co-Founder and
Chief Executive Officer. "A core tenet of the T1D Consortium
and its parent organization, C-Path, is to foster advances in
science and research through collaboration. This mindset aligns
perfectly with Provention's business and development philosophy and
our strategy of partnering with leading pharmaceutical companies to
identify and re-deploy drugs for the purpose of intercepting and
preventing immune-mediated diseases, such as T1D."
"We look forward to Provention Bio joining the T1D Consortium
and providing their perspective as we work together with all of our
members to qualify susceptibility/risk biomarkers to support
clinical trials of new medicines for T1D patients in need," said
Inish O'Doherty, Executive Director of the T1D
Consortium.
Jessica Dunne, Director of
Research at JDRF and the Co-Director of the T1D Consortium added,
"We at JDRF believe that regulatory qualification of islet
autoantibodies as a susceptibility/risk biomarker is a critical
step for delaying and ultimately preventing T1D, and we are excited
to welcome Provention Bio into the T1D Consortium. Their
commitment to delivering therapies to individuals living with, and
at-risk for developing, T1D is well-aligned with both JDRF and the
Consortium."
Additional C-Path T1D Consortium members include academic
collaborators in the US and Europe, along with the institutional
observers, the United States Food and Drug Administration (US FDA),
National Institutes of Health (NIH), European Medicines Agency
(EMA) and Innovative Medicines Initiative (IMI).
The initial goal of the C-Path T1D Consortium is to achieve FDA
and EMA regulatory qualification of the islet autoantibodies as
susceptibility/risk biomarkers for T1D disease progression,
facilitating the conduct of T1D interception studies. The addition
of Provention Bio to the consortium will provide the impetus to
build on this initial regulatory foundation and enable the
examination of the presentation of the islet autoantibodies as a
clinically meaningful outcome in T1D prevention clinical
trials.
Dr. Francisco Leon, Chief
Scientific Officer of Provention Bio, concluded, "We look forward
to lending our vision, insight and experience as we continue to
advance our two T1D clinical programs, PRV-031 and PRV-101,
recognizing that intercepting T1D rests in the ability to identify
those patients in the early stages of the disease and the islet
autoantibody qualification provides us the means to do this. We
hope to build on this effort for the initial presentation of the
islet autoantibodies to be considered a clinically meaningful
outcome in T1D prevention trials."
About T1D
Type 1 diabetes (T1D) is an autoimmune
disease that occurs when a person's pancreas stops producing
insulin, the hormone that controls blood-sugar levels. T1D develops
when the insulin-producing pancreatic beta cells are mistakenly
destroyed by the body's immune system. The cause of this
attack is still being researched, however scientists believe the
cause may have genetic and environmental components, including
viral infection. Presently, there is no known preventative
approach or cure for T1D.
About Critical Path Institute
C-Path (Critical Path
Institute) is an independent, nonprofit organization established in
2005 as a public and private partnership. C-Path's mission is to
catalyze the development of new approaches that advance medical
innovation and regulatory science, accelerating the path to a
healthier world. An international leader in forming collaborations,
C-Path has established numerous global consortia that currently
include over 1,500 scientists from government and regulatory
agencies, academia, patient organizations, disease foundations, and
dozens of major pharmaceutical and biotech companies. C-Path is
headquartered in Tucson, Arizona,
with additional staff in multiple remote locations. For more
information, visit, www.c-path.org.
About JDRF
JDRF is the leading global organization
funding type 1 diabetes (T1D) research. Our mission is to
accelerate life-changing breakthroughs to cure, prevent and treat
T1D and its complications. To accomplish this, JDRF has invested
more than $2 billion in research
funding since our inception. We are an organization built on a
grassroots model of people connecting in their local communities,
collaborating regionally for efficiency and broader fundraising
impact, and uniting on a national stage to pool resources, passion,
and energy. We collaborate with academic institutions,
policymakers, and corporate and industry partners to develop and
deliver a pipeline of innovative therapies to people living with
T1D. Our staff and volunteers throughout the United States and our six international
affiliates are dedicated to advocacy, community engagement and our
vision of a world without T1D. For more information, please visit
jdrf.org or follow us on Twitter: @JDRF
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 diverse portfolio was assembled with
product candidates that have undergone clinical testing but may
have been underdeveloped or deprioritized assets at other
companies. Provention's mission is to in-license, transform and
develop clinical-stage, or nearly clinical-stage, therapeutic
candidates targeting the high morbidity, mortality and escalating
costs of autoimmune and inflammatory diseases including: type 1
diabetes (T1D), Crohn's disease, ulcerative colitis, celiac
disease, lupus, and certain life-threatening viral diseases. For
more information on Provention Bio, please visit
www.proventionbio.com.
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 quarterly report on Form 10-Q for the quarter ended
September 30, 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.
Media & Investor Contacts
Jason Rando / Joshua
Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
T: 212 375 2665 / 212 375 2664
jrando@tiberend.com
jdrumm@tiberend.com
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SOURCE Provention Bio, Inc.