PRINCETON, N.J., July 17, 2012 /PRNewswire/ -- Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the National Institute of Allergy and Infectious Diseases (NIAID) has awarded Soligenix a Small Business Innovation Research (SBIR) grant to support further preclinical development of OrbeShield ™ (oral beclomethasone 17,21-dipropionate) as a treatment for gastrointestinal acute radiation syndrome (GI ARS). The award will provide Soligenix with approximately $600,000 over a two-year period to conduct the study. Acute GI ARS is a potentially life-threatening consequence of exposure to high dose radiation following a serious nuclear event. There is no effective therapy approved for the treatment of GI ARS.
In a recently completed study in beagle dogs, statistically significant survival was observed in dogs that received OrbeShield ™ therapy starting both 2 and 24 hours following exposure to total body irradiation (TBI). The program is designed to simulate real world scenarios in which people exposed to various levels of radiation would not be able to reach care centers immediately after a nuclear event. In the former study, untreated dogs died at a median time of 8 days when exposed to high dose radiation of 10-12 Gray (Gy) even if the dogs were given intensive supportive care such as antibiotics, intravenous fluids and anti-emetics. Transplant of autologous bone marrow cells also had no effect on the rate of death of the exposed animals due to acute effects on the GI tract. During the observation period, the survival of dogs was strongly correlated to the recovery from acute radiation damage to the GI tract. These studies were conducted by George E. Georges, MD, at the Fred Hutchinson Cancer Research Center (FHCRC) under an NIAID funded grant.
This new grant will support further evaluation of OrbeShield ™ in the prevention of GI ARS in the beagle dog model. Use of this distinctive model will provide a significant step forward in the development of OrbeShield ™. These studies will once again be conducted in conjunction with Dr. Georges at FHCRC."We are encouraged with the promising survival results observed to date with OrbeShield ™ in the beagle model as a post-exposure therapy for the treatment of GI ARS," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With renewed support from NIAID, we look forward to working with Dr. Georges to continue development of OrbeShield ™ with the aim of addressing this critical unmet medical need." About GI ARSARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow (hematopoietic syndrome) and the GI tract. In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gray (Gy) are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute gastrointestinal injury which can result in death in 5-10 days. The GI tract is highly sensitive to radiation damage and substantial GI injury after radiation exposure can result in death. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI. Although lethal hematopoietic injury can be rescued by bone marrow transplantation and several therapeutic drugs, there is no established treatment or preventive measure for GI damage that occurs after high dose radiation. Therefore, there is an urgent need to develop specific countermeasures against the lethality caused by intestinal exposure to radiation and against the pathophysiological manifestations of radiation-induced GI injury. About OrbeShield ™ 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 acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. Soligenix is also developing oral BDP for the prevention/treatment of other 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 a Phase 1 clinical trial in normal volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million NIAID grant supporting development of new thermostable vaccine technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of GI ARS and has demonstrated statistically significant preclinical survival results in a canine GI ARS model. 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.
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