Breakthrough Regenerative Therapeutics Company Establishes Scientific Advisory Board – PR Newswire (press release)

Posted: May 4, 2017 at 3:01 pm

MONTREAL, May 4, 2017 /PRNewswire/ --Fortuna Fix Inc.("Fortuna"), a private, clinical-stage biotech company, is aiming to be the first to eliminate the need for embryonic and fetal stem cells by using direct reprogramming of autologous cells to treat neurodegenerative diseases. Fortuna announced today the launch of its Scientific Advisory Board ("SAB") with Professor Michael Fehlings, MD, PhD; Father Kevin FitzGerald, S.J., PhD; Col. (R) Dallas Hack, MD, MPH; and Professor James Giordano, PhD.

"We are excited and honored to have these world-leading experts join our SAB," says CEO Jan-Eric Ahlfors. "We look forward to working with them to bring our novel regenerative medicine solutions to patients suffering from neurotrauma and neurodegeneration."

Fortuna's two flagship technologies autologous directly reprogrammed neural precursor cells ("drNPC") and Regeneration Matrix ("RMx") are poised to lead a revolution in neuro-regeneration.

For the first time, patients suffering from neurotrauma or neurodegeneration will be able to get treated with autologous neural stem cells produced by direct reprogramming (i.e. starting with and only using the patient's own cells, bypassing use of pluripotent stem cells and avoiding harvesting and use of human embryos or fetuses). The method of direct reprogramming developed by Fortuna relies on an ethical, rapid, high throughput, low cost and fully automated manufacturing process. As drNPC do not involve any genetic engineering, pluripotent stem cells, or use of immune-suppression, it provides patients with personalized stem cells that are also expected to have a greater safety profile. In addition, drNPC are expected to replace dead neural cells, something that no other current technology can do effectively.

RMx is a unique and highly efficient bio-scaffold for the promotion of neural tissue regrowth.

"Our testing of drNPC at the Krembil Neuroscience Centre of the University Health Network in various Spinal Cord Injury ("SCI") animal models to characterize their regenerative capacity and safety profile indicates that drNPC are a promising source of therapeutic stem cells with potential for tissue preservation and functional improvement after SCI. I am highly encouraged by the reprogramming efficiency of drNPC and look forward to leading the clinical development of drNPC for SCI," says Professor Fehlings, after working on the drNPC in his lab for two years.

Dr. Hack further remarks:"Fortuna's autologous drNPC represent a major advance in cell therapy for treatment of CNS injury and degeneration. For the first time, neurons, astrocytes and oligodendrocytes the three type of cells of the brain and spinal cord can be repaired and replaced where these cells have died or been destroyed due to trauma or neurodegenerative disease. Fortuna's proprietary automated manufacturing addresses a key hurdle of personalized cell therapy, making drNPC commercially viable both at small and large scale"

"Stem cell therapeutics have been plagued with controversy and hype, raising ethical and political issues that have resulted in a relatively hostile funding environment for research and development in the field. I am excited to work alongside Fortuna to help advance development of their ethical and commercially viable platform for cell therapeutics to benefit patients, their families, and our entire society," says Father FitzGerald.

The SAB members encompass unique expertise in key areas of importance for the company:

Professor Michael G. Fehlings, MD, PhD, FRCSC, FACS

Dr. Michael Fehlings is a world-renowned Neurosurgeon focusing on Spinal Cord Injury and a leader in the field of stem cell therapeutics for SCI. Dr. Fehlings is the Vice Chair of Research for the Department of Surgery, Co-Director of the Spine Program and a Professor of Neurosurgery at the University of Toronto. He is well known for his work on early decompressive surgery, which demonstrated significant improvement on neurological and functional outcomes after SCI that had an important impact on how spinal trauma is managed today. Recently, during the Henry Farfan Award ceremony (2013), he was described as the "single most influential active spinal cord injury researcher and clinician in the world."Dr. Fehlings is also the recipient of the coveted Olivecrona Award from the Karolinska Institute in Stockholm, Sweden (known as the "Nobel Prize of Neuroscience").

Dr. Fehlings has been an integral part of the work performed by independent validators sponsored by CIHR (Canadian Institutes of Health Research) on Fortuna's technology. Dr. Fehlings' work was presented at the annual International Society for Stem Cell Research (ISSCR) conference in June 2016 in San Francisco with a follow up to be presented at the ISSCR in June 2017 in Boston.

Father Kevin T. FitzGerald, S.J., PhD, PhD

Father Kevin FitzGerald is a Professor at Georgetown University and advisor to the Vatican on Bioethics (including human genetic engineering, cloning, stem cell research, and personalized medicine). Father FitzGerald is the Dr. David Lauler Chair of Catholic Health Care Ethics in the Center for Clinical Bioethics at Georgetown University, and an Associate Professor in the Department of Oncology at the Georgetown University Medical Center. He is a founding member of Do No Harm, a member of the ethics committee for the March of Dimes, a member of the Genetic Alliance IRB, and a member of the Georgetown-MedStar Hospital Ethics Committee. Father FitzGerald has been a Corresponding Member of the Pontifical Academy of Life since 2005, and has been a Consultor to the Pontifical Council for Culture since 2014. He has a Ph.D. in molecular genetics, and a second Ph.D. in bioethics, from Georgetown University. His research efforts focus on the investigation of abnormal gene expression in cancer, and on ethical issues in biomedical research and medical genomics.

Col. (R) Dallas Hack, MD, MPH, MMS, CPE

Dr. Dallas Hack, recently retired from the US military, is one of the leaders of military medicine of his time, with a particular focus on brain health (Traumatic Brain Injury ("TBI") and concussion). He served as the Director of the US Army Combat Casualty Care Research Program and Chair of the Joint Program Committee for Combat Casualty Care from 2008 to 2014 and as the Senior Medical Advisor to the Principal Assistant for Research and Technology, US Army Medical Research and Materiel Command from 2014 to 2015. He coordinated more than 70% of the Department of Defense trauma research to improve battlefield trauma care of those injured in combat at a time when the Department of Defense funded more TBI research than any other organization in the world because of the increasing awareness of the massive burden of TBI in the military. He has held numerous military medical leadership positions, including Chief of Clinical Services at Fort Knox, KY, Commander of the NATO Headquarters Healthcare Facility, and Command Surgeon at the strategic level during Operations Enduring Freedom and Iraqi Freedom.

Col. (R) Dallas Hack has received numerous military awards, including the Bronze Star, two Legion of Merit awards, and seven Meritorious Service Medals and was inducted as a Distinguished Member of the Military Order of Medical Merit. He has appointments from the School of Medicine, University of Pittsburgh as Adjunct Professor of Neurosurgery, and from the Department of Physical Medicine and Rehabilitation, School of Medicine, Virginia Commonwealth University as Associate Clinical Professor.

Professor James Giordano, PhD, MPhil

Dr. James Giordano is Professor in the Departments of Neurology and Biochemistry, and Chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics of Georgetown University Medical Center, Washington, DC. Prof.Giordano has served as a member of the Neuroethics, Legal and Social Issues Advisory Panel of the Defense Advanced Research Projects' Agency (DARPA), as a Senior Science Advisory Fellow of the Strategic Multilayer Assessment Branch of the Joint Staff of the Pentagon, is an appointed member of the Secretary of Health and Human Services Advisory Council for Human Research Protection, and is a Research Fellow of the European Union Human Brain Project. In recognition of his ongoing work, Prof. Giordano was elected to the European Academy of Science and Arts.

About Fortuna Fix Inc.

Fortuna is a private, clinical-stage biotech company with a patented direct cell reprogramming technology platform together with a patented bio-scaffolding technology for treatment of neurodegenerative diseases and neurotrauma. The company is focused on clinical development of its platforms for a range of neurodegenerative diseases including SCI, Parkinson's disease, stroke, TBI, and ALS. The company has developed a proprietary fully automated GMP manufacturing system for production of drNPC, initially to be used in clinical trials in Parkinson's disease and Spinal Cord Injury.

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Breakthrough Regenerative Therapeutics Company Establishes Scientific Advisory Board - PR Newswire (press release)

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