Soligenix, Inc. (Nasdaq: SNGX) announced today the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it advances the clinical development of SGX945 (dusquetide) for the treatment of Behçet's Disease. The Company previously announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for dusquetide in the treatment of oral lesions of Behçet's Disease.
"I am honored to have such a prestigious and dedicated group of physicians committed to working with us as we develop dusquetide therapy for Behçet's Disease," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We have assembled some of the world's leading experts in this field who collectively have hundreds of publications and have the experience of treating thousands of patients with this chronic condition. The initiation of a Phase 2a clinical study in Behçet's Disease later this year will be another important milestone for our company and we look forward to working with the MAB to advance this program."
Comprised of internationally renowned rheumatologists with extensive experience in Behçet's Disease, the MAB will play an important advisory role in the conduct of the upcoming Phase 2a clinical study, as well as in the design of subsequent clinical studies and associated regulatory interactions with health authorities. The MAB will provide feedback, input and guidance on clinical strategies and their implementation, as well as on other critical items, such as health economics and reimbursement, to assist Soligenix in meeting the needs of patients suffering from Behçet's Disease.
The MAB Members
Gülen Hatemi, MD
Dr. Hatemi is one of the world's leading physicians in the treatment of Behçet's Disease and leads the largest Behçet's research center in the world at Istanbul University – Cerrahpaşa, Behçet's Disease Research Center. Dr. Hatemi has over 250 publications in her field and has conducted numerous clinical research trials to understand the life impact of Behçet's syndrome, to develop management strategies, and to improve outcome measures for clinical trials of Behçet's Disease. Dr. Hatemi is the convener of the Disease Assessment Study Group of the International Society for Behçet's Disease and co-chair of the OMERACT (Outcome Measures in Rheumatology) Behçet's syndrome working group where she focuses on developing outcome measures for clinical trials and improving outcomes for patients with Behçet's Disease. She is also a member of the European Union of Medical Specialists Section of Rheumatology. Dr. Hatemi completed rheumatology training in Istanbul University, Cerrahpaşa Medical School, Department of Internal Medicine, after completing residencies in both Internal Medicine and Pulmonary Medicine at Instanbul University. She received her medical degree from Cerrahpaşa Medical School.
Johannes Nowatzky, MD
Dr. Johannes Nowatzky is the Saul J. Farber Associate Professor of Medicine and Pathology at New York University (NYU) Grossman School of Medicine, where he directs the NYU Behçet's Disease Center. Dr. Nowatzky has extensive experience in Behçet's Disease, seeing thousands of patients, and sits on the Medical Advisory Board for the American Behçet's Disease Foundation. Clinically trained in the Middle East, Europe, and the U.S., he has unique expertise with Behçet's Disease from large referral centers in these regions. Dr. Nowatzky is a physician-scientist who, in addition to running the most extensive clinical Behçet's Disease program in the U.S., directs an immunology research laboratory focused on the biology of Behçet's Disease and ocular inflammation. His numerous publications in the field include primary research in impactful immunology/rheumatology journals, such as Annals of the Rheumatic Diseases. Dr. Nowatzky completed his fellowship at NYU Langone Medical Center and his residency in Internal Medicine at Hadassah Medical School, Israel. He received his medical degree from the Faculty of Medicine, Freie University Berlin, Germany.
Andrew Sulich, MD
Dr. Sulich is a rheumatologist in private practice at Shores Rheumatology, St. Clair Shores, MI, and Chief of Rheumatology at Ascension Saint John Medical Center in Detroit. He is also Assistant Clinical Professor at the William Beaumont Oakland University School of Medicine, and a clinical instructor of rheumatology for the residency programs at Saint John Hospital and Medical Center in the Beaumont Hospital System. Dr. Sulich has been honored with multiple awards, including Hour magazine "Top Docs" for 2010 to 2020. Dr. Sulich is a fellow of the American College of Rheumatology and is a member of organizations such as the American College of Physicians, the Michigan State Medical Society, the Arthritis Foundation and a member of the Medical Advisory Board for the American Behçet's Foundation. Dr. Sulich completed his internship at Mount Carmel Mercy Hospital in Detroit. He completed his residency at St. John Hospital and Medical Center, where he served as chief resident. His rheumatology fellowship was completed at Henry Ford Hospital and he received his medical degree from the American University of the Caribbean School of Medicine in Saint Maarten.
Yusuf Yazici, MD
Dr. Yazici is an internationally renowned rheumatologist, researcher and expert in clinical trial design and management. He is a Clinical Associate Professor at NYU. His areas of interest are Behçet's Disease, osteoarthritis, rheumatoid arthritis, early arthritis, patient reported outcomes, database and registry management and monitoring of arthritis patients in regard to clinical response and adverse events related to treatment. He has published more than 250 medical papers and book chapters and has given numerous national and international presentations. Dr. Yazici has been Chief Medical Officer of Biosplice Therapeutics, Inc. since 2013, leading the development of new therapies for osteoarthritis, various oncologic conditions and Alzheimer's disease, and sits on the Medical Advisory Board for the American Bechet's Disease Foundation. Dr. Yazici completed his fellowship in rheumatology at the Hospital for Special Surgery and Weill Medical College of Cornell University, New York City, NY and his residency in internal medicine at Creighton University, Omaha, NE. Dr. Yazici received his medical degree from Istanbul University, Istanbul, Turkey.
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