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.
George B. McDonald, MD, is a Professor of Medicine at the University of Washington School of Medicine and a Member at the Fred Hutchinson Cancer Research Center, in the Gastroenterology/Hepatology Section. His overall research goals have been the reduction of morbidity from cancer treatment, improved survival, and prevention of late sequelae of cancer treatment. Dr. McDonald is recognized internationally as an expert in the field of gastroenterology. His research is focused on gastrointestinal and hepatobiliary complications of hematopoietic cell transplantation, specifically problems involving the toxicity of high-dose radiation/chemotherapy regimens that are used to prepare patients for transplantation and acute and chronic Graft-versus-Host disease (GVHD) involving the gastrointestinal tract and liver. He has recently developed and validated a new method of assessing the severity of acute GVHD, called the acute GVHD Activity Index, an accurate predictor of transplant-related mortality. He was the lead investigator on the clinical trials that pioneered the use of topical corticosteroid therapy with oral beclomethasone dipropionate for GI GVHD. He is also collaborating with Dr. George Georges on evaluating the effects of radiation injury on the GI tract in the canine model of GI-ARS. He has more than 200 peer-reviewed publications.
George A. Parker, DVM, PhD, is currently Vice President, Pathology at WIL Research. Dr. Parker is a graduate of Auburn University College of Veterinary Medicine. He completed a residency program in veterinary pathology at the Armed Forces Institute of Pathology and a PhD program in molecular and cellular immunology at the University of Medicine and Dentistry of New Jersey. He is certified as a pathologist by the American College of Veterinary Pathology, as a toxicologist by the American Board of Toxicology, and is a Fellow of the International Academy of Toxicologic Pathologists. He has been continuously involved in toxicologic pathology since 1978. Dr. Parker has served as study pathologist on over 1000 good laboratory practice (GLP) and non-GLP toxicology studies, and has served as primary reviewer for more than 1400 GLP pathology reports. He currently directs a pathology department that includes 13 pathologists and approximately 70 technical or clerical staff members. He has more than 60 peer-reviewed publications.
About GI ARS
ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs. In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days. The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI. Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.
OrbeShield contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. OrbeShield is formulated for oral administration in GI-ARS patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the distal portions of the GI tract. BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. Oral BDP may also have application in treating other GI disorders characterized by severe inflammation such as Crohn's disease and radiation enteritis.
About Soligenix, Inc.
Soligenix is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid that has been initially developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. Soligenix is also developing proprietary formulations of oral BDP for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), which is the subject of a recently completed National Cancer Institute (NCI)-supported Phase 1/2 clinical trial.
Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure. RiVax has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax and VeloThrax are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax. Soligenix is also developing OrbeShield for the treatment of gastrointestinal acute radiation syndrome (GI-ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
SOURCE Soligenix, Inc.