The SAB is expected to serve as a strategic network of scientific, medical and clinical experts to Rexgenero as the company progresses the development of its pipeline in Critical Limb Ischemia (CLI) and initiates phase III trials with its lead candidate Rexmyelocel-T (REX-001), an autologous cell therapy. The SAB is also expected to play an integral role for the company in assessing opportunities for its cell-based therapies in other disease areas with unmet medical needs.
Joe Dupere, Rexgenero's CEO, said "We are thrilled to have attracted leading authorities in the field of cardiovascular diseases, wound healing and cell therapies to support Rexgenero as we develop advanced breakthrough therapies in these areas. The formation of our SAB serves as a clear endorsement for scientific, medical and clinical potential of our lead compound Rexmyelocel-T, which we believe could be a transformative advance for the treatment of Critical Limb Ischemia, a poorly treated disease."
Professor Jill Belch FRCP, MD (Hons), FMedSci, FRSE, OBE
Professor Belch graduated as a Doctor from the University of Glasgow (MB ChB), becoming a Lecturer within the University Department of Medicine, where she completed her Research MD degree in 1987. She was appointed Senior Lecturer with Honorary Consultant status at the University Department of Medicine in Ninewells Hospital, Dundee, also in 1987, and became Professor of Vascular Medicine in 1995. She was Director of the Tayside Clinical Trials Centre before becoming the Director of the Tayside Medical Science Centre (TASC) and the Tayside R&D Director. She is a founder Fellow of the Academy of Medical Science, and a Fellow of the Royal Society, Edinburgh. She was awarded an OBE in 2016.
She was involved in the first Royal College of Physicians, Edinburgh, PAD Guideline (Medical management of peripheral arterial diseases) in 1998, leading to a second one in 2007 (Management of peripheral arterial disease), she participated in the recent NICE Quality Standard Advisory Committee (QSAC) for peripheral arterial disease.
Dr Marianne Brodmann MD
Dr Marianne Brodmann is an interventional angiologist, vascular specialist and expert in clinical trials for the treatment of cardiovascular diseases. Dr Brodmann is the Head of Division of Angiology, Head of Clinical Research at Division of Angiology at the Medical University of Graz, Austria.
Active in many national and international societies Dr Brodmann is a Fellow of the European Society of Cardiology, Board Member of the European Union of Medical Specialist (UEMS), past President of the ÖGA (Austrian Society of Angiology) and National Delegate of the IUA (International Union of Angiology).
Research activities include anticoagulation and thrombolysis, new endovascular technologies in the peripheral field and evaluation of the nature of restenosis. She also founded a research establishment for experimental angiology animal models at the University of Graz. Dr Brodmann has participated in over 50 international clinical trials including Principal Investigator for the Bioflex I, Lutonix BTK and TOBA-BTK clinical trials and Steering Committee of the CVI Ingenuity trial.
Professor Keith Harding CBE FRCGP FRCP FRCS
Professor Keith Harding has had a longstanding interest in wound healing and was Director of TIME Institute (Translation, Innovation, Methodology and Engagement) and Head of Wound Healing Research Unit, School of Medicine, Cardiff University and Clinical Lead for Wound Healing in the Cardiff & Vale NHS Trust from 2011 to 2013. In September 2013 he was appointed as University Dean of Clinical Innovation at Cardiff University and in 2014 was appointed as Medical Director of the Welsh Wound Innovation Centre. He is Editor-in-Chief of the International Wound Journal. He was the First President of the European Pressure Ulcer Advisory Panel, First Recorder of the European Wound Management Association and is a Past President of the European Tissue Repair Society. He was Chair of a number of Expert Working Groups that produced a range of International Consensus Documents from 2004 to 2016. He has obtained funding of over £50 million from a range of academic, commercial and clinical sources since the Wound Healing Research Unit was created in 1991. He was awarded the CBE in the New Year Honours list in January 2013 for Services to Medicine and Health Care.
Professor William Hiatt MD, FACP, FAHA
William R. Hiatt, MD, is a professor at the University of Colorado School of Medicine, Division of Cardiology with a clinical and research focus in vascular medicine. He is president of CPC Clinical Research which is a university-affiliated, non-profit cardiovascular and clinical trials research organization.
Dr Hiatt is a past chairman of the United States Food and Drug Administration Cardiovascular and Renal Advisory Committee (2003-08) and past member of the FDA Endocrinologic and Metabolism Advisory Committee (2010-2016).
He has been elected several times as Best Doctors in America (most recently in 2012) and in 2014 he was recognized as a Distinguished Scientist of the American Heart Association.
Dr Hiatt serves on the editorial board of the Journal of Vascular Medicine, the Cochrane Review Group, is guest editor for Circulation and section editor for the Journal of the American College of Cardiology.
Research activities include studies evaluating the pathophysiology and epidemiology of peripheral artery disease, mechanisms of supervised exercise as an effective treatment modality for claudication, and numerous clinical trials to develop new therapies for claudication and critical limb ischemia. His research at the CPC has pioneered new methods to control endpoint variability in clinical trials. He has authored 240 peer-reviewed papers.
Professor Paul Quax PhD
Paul H.A. Quax, Ph.D. is Professor in Experimental Vascular Medicine at the Department of Vascular Surgery of the Leiden University Medical Center, the Netherlands and has a main research interest in post-interventional vascular remodeling. Over the past decades he has extensively studied not only the pathophysiology of peripheral artery disease but also of vein graft disease, restenosis and accelerated atherosclerosis. He has a strong interest in exploring novel therapeutic options to induce neovascularisation, including gene and cell therapy, with the goal to define new strategies for therapeutic angiogenesis and arteriogenesis. He is an Established Investigator of the Netherlands Heart Foundation, Fellow of the American Heart Association and has published more the 175 papers in peer-reviewed journals.
Rexgenero is a clinical-stage regenerative medicine company developing innovative cell-based therapies targeting serious diseases with unmet medical needs.
The Company's lead candidate Rexmyelocel-T (REX-001) is a ground-breaking autologous cell therapy about to enter a phase III clinical trial in patients with Critical Limb Ischemia (CLI), a poorly treated disease. Rexmyelocel-T showed strong efficacy in Phase I/II and Phase II trials with resolution of CLI in the majority of patients, offering the potential to normalize lives of CLI patients by reducing pain, hospital stay and removing the need for amputation.
Rexgenero's intention is to drive the clinical development of Rexmyelocel-T and market the specialty product in major territories.
A privately owned company, Rexgenero draws on an exceptional understanding of the fundamental science of cell therapy developed by the Andalusian Health Authority (Servicio Andaluz de Salud and Andalusian Initiative of Advanced Therapies).
The Company was founded in 2014 and is headquartered in London (UK) with R&D operations in Seville (Spain).
For more information, please visit http://www.rexgenero.com
Joe Dupere, CEO
Citigate Dewe Rogerson
Sylvie Berrebi, Katja Stout