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Provention Bio Appoints Leading T1D Expert, Dr. Mark Rigby, as Vice President, Clinical Development
- Provention strengthens its strategic platform in type 1 diabetes (T1D) interception and prevention
- Dr. Rigby's leadership and expertise in T1D will enhance Provention's clinical development of T1D pipeline, including PRV-101, a coxsackievirus B vaccine to potentially prevent T1D onset, and PRV-031, a Phase 3 anti-CD3 monoclonal antibody for the interception of early-onset T1D

OLDWICK, N.J., July 31, 2018 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq:PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, announced today the appointment of Mark Rigby, MD, PhD, FAAP, FCCM to the role of Vice President, Clinical Development. A key opinion leader in T1D research and development, Dr. Rigby joins Provention's clinical and scientific team to advance the company's programs targeting T1D interception and prevention. 

(PRNewsfoto/Provention Bio, Inc.)

Provention's development pipeline includes two products addressing T1D – PRV-031, a Phase 3 stage asset for the interception of early-onset T1D, and PRV-101, a polyvalent coxsackievirus B vaccine, which Provention is developing to potentially prevent up to 50% of worldwide T1D cases.  Reporting to Dr. Eleanor Ramos, Provention's Chief Medical Officer and Chief Operating Officer, Dr. Rigby will initially lead the planning and initiation of a PRV-031 pivotal Phase 3 clinical trial in early-onset T1D.

"Having successfully completed our initial public offering, Provention is now keenly focused on advancing our clinical development pipeline targeting disease interception and prevention in T1D and other immune-mediated diseases," stated Ashleigh Palmer, CEO of Provention Bio. "As a recognized key opinion leader in T1D, Mark is an important addition to our clinical team.  We look forward to benefitting from his more than two decades of clinical, academic, and pharma industry experience advancing immune therapeutics for T1D and other autoimmune disorders."

Dr. Rigby joins Provention after more than 25 years of clinical and research experience in academics and industry. Most recently he served as Director, Immunology Early Development and Translational Medicine for Janssen Pharmaceuticals, a Johnson and Johnson Company, where he led multiple clinical and research programs including clinical trials focused on T1D interception in new onset and pre-symptomatic disease.  He also participated in advancing several early-stage assets through first in human studies, developing progressive immune monitoring assessments, and leading general strategy in the immunology therapeutic area.

"Mark's recent work with Janssen in the field of T1D interception and his past research in the area of pediatric diabetes will play an important role as we progress towards initiation of a pivotal Phase 3 clinical trial for PRV-031 to intercept early-onset T1D," said Dr. Ramos. "Provention is excited to be working with Mark and benefitting from his years of T1D experience, drug development and caring for patients with this and other life-altering diseases." 

"As a practicing physician, my primary goal was to treat my patients in real time, addressing symptoms of a condition that placed them at significant risk in the present. While this is the current convention in medicine, it can no longer be our goal," stated Dr. Rigby. "While important advances have been made over the past several decades in understanding the root causes of this disease, it's now time to bring these advances to patients. Treatments should be administered upstream in the course of T1D, before the inevitable life-impacting side effects of the disease manifest themselves. In particular, we want to develop therapies to stop the destruction of insulin producing cells and revive them so individuals with T1D do not need to give themselves multiple injections every day for the rest of their lives, sparing them from the acute and long term complications and misery of this disease. Our vision is intercepting autoimmune disease before it becomes a chronic condition and, ultimately, looking to prevent these diseases entirely.  Provention is at the forefront of this new approach, and I look forward to bringing my experience, understanding and know-how to make immediate and long-lasting contributions to this ground-breaking company."

Prior to his role at Janssen, Dr. Rigby had an accomplished academic career. Dr. Rigby obtained his undergraduate degree from Duke University, MD and Ph.D. in Biological Sciences/Immunology from the University of Massachusetts, and completed clinical residency and fellowship training at The John Hopkins Hospital.

Dr. Rigby was Associate Professor in Pediatrics and Surgery at Emory University School of Medicine, Director of Research in the Division of Pediatric Critical Care Medicine and conducted basic and clinical research in T1D and immune regulation in the Emory Transplant Center.  He was then Academic Section Chief in Pediatric Critical Care, Associate Professor in Pediatrics, Scientist in the Wells Center Program in Diabetes Research and Co-Director Pediatric Translational Research and Integrative Biology Center at Indiana University.

An author of numerous seminal publications and presentations on basic and clinical studies in T1D, transplantation and pediatric critical care, Dr. Rigby has also served as Protocol Chair and on the Steering Committee for the Immune Tolerance Network (ITN) and active in a variety of science and medical societies.

About Provention Bio, Inc.
Provention Bio, Inc. is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease.  Our 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, lupus, and certain life-threating viral diseases. For more information on Provention Bio, please visit

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; and our need for additional financing. 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.

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