PRINCETON, N.J., Oct. 3, 2012 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today the formation of a Scientific Advisory Board (SAB) to provide strategic guidance to the Company as it relates to the development of OrbeShield ™ (oral beclomethasone dipropionate, or oral BDP) for the treatment of gastrointestinal acute radiation syndrome (GI-ARS).
Comprised predominantly of radiation biology and gastroenterology thought leaders, the SAB will play an important advisory role in the design and conduct of the OrbeShield ™ development program and associated interactions with government agencies such as the Biomedical Advanced Research and Development Authority (BARDA), National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The SAB will routinely provide feedback, input and guidance on development strategies and their implementation as well as on other critical issues.
The continued development of OrbeShield ™ as a mitigator of acute GI-ARS is based on results obtained from studies conducted in a canine model of GI-ARS. The studies were performed by George E. Georges, MD, at the Fred Hutchinson Cancer Research Center in Seattle, WA as part of a NIH funded study. The results indicated a statistically significant survival advantage in canines that received OrbeShield ™ therapy starting both 2 and 24 hours following exposure to total-body irradiation (TBI) when compared with placebo control. Untreated canines succumbed to the GI-ARS at a median time of 8 days when exposed to high dose radiation of 10-12 Gray (Gy) even if the canines were given intensive supportive care such as antibiotics, intravenous fluids and anti-emetics. A subsequent study to replicate and expand upon the observations made in Dr. George's study is in the process of being initiated and, like the previous study, is also supported by a recent NIH Small Business Innovation Research (SBIR) grant award.
"We are pleased to be able to attract such knowledgeable and enthusiastic individuals to participate as members of this critical advisory board," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The formation of this SAB will provide us with essential scientific guidance necessary to build this important development program with the goal of obtaining approval via the FDA Animal Rule. We look forward to working with the SAB and building upon the work of Dr. Georges and his team in Seattle."The SAB Members George E. Georges, MD, is an Associate Professor of Medicine at the University of Washington and Associate Member, Fred Hutchinson Cancer Research Center, is recognized internationally as an expert in ARS, with a specific focus on bone marrow and GI components. Dr. Georges' research focus is on development of radiation counter-measures in the dog model with the goal of translating the findings to the clinical care of patients. He is the Principal Investigator of several NIH sponsored grants including development of radiation mitigators for acute radiation syndrome associated neutropenia and thrombocytopenia, as well as the gastrointestinal syndrome. This research includes canine studies with new cytokines for improving hematopoietic recovery and immune reconstitution after radiation. In addition, he has developed the canine model of GI-ARS to study novel agents to mitigate the effects of radiation injury in the gut. He has more than 70 peer-reviewed publications. Thomas MacVittie, MS, PhD, is a Professor of Radiation Oncology and Pathology at the University of Maryland School of Medicine and is recognized internationally as an expert on the effects of radiation on the hematopoietic and gastrointestinal systems in non-human primates and their treatment. His early work demonstrated the efficacy of medical management (supportive care) and hematopoietic growth factors on increasing survival in lethally irradiated large animal models. The MacVittie group's database demonstrating the effect of cytokines on enhancing survival and recovery of hematopoiesis serves as the focal point for current efforts to design the first pivotal trials under the FDA's animal rule to determine the treatment efficacy of candidate drugs/biologics for final FDA approval. Dr. MacVittie has served as an advisor to the World Health Organization (WHO) Collaborating Centers in Radiation Emergency Medical Preparedness and Assistance and the International Council on Radiation Protection and as a member of North Atlantic Treaty Organization (NATO) Radiation Research Study Groups. He is a member of the Centers for Disease Control and Prevention (CDC) Strategic National Stockpile Radiation Working Group, the International Association of Radiopathology, the American Society of Hematology, the International Society of Experimental Hematology, Radiation Research and the International Society of Cellular Therapy. Dr. MacVittie is a member of the editorial board of the journal Stem Cells and serves as an ad hoc reviewer for numerous journals and NIH/National Institute of Allergy and Infectious Diseases (NIAID) and Department of Defense (DoD) grants and contracts. He was also a consultant for the International Atomic Energy Agency (IAEA) and Canadian Defense Research Establishment and also served on the first National Biodefense Science Board Federal Advisory Committee at the invitation of the Secretary, U.S. Department of Health and Human Services. He has more than 150 peer-reviewed publications.
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