Soligenix Announces Presentation of OrbeShield Data at Annual Radiation Research Society Meeting
Princeton, NJ - September 28, 2012 - Soligenix, Inc. (OTCQB:
SNGX) (Soligenix or the Company), a development stage
biopharmaceutical company, announced today that results of a study
in a canine model of OrbeShield™ (oral beclomethasone
17,21-dipropionate) will be presented at a poster session entitled,
"Post-exposure oral 17,21-beclomethasone dipropionate (BDP)
improves survival in a canine gastrointestinal acute radiation
syndrome (GI ARS) model." The presentation will be made during the
58th Annual Meeting of the Radiation Research Society to be held in
San Juan, Puerto Rico on September 30 through October 3,
2012.
In the recently completed study in canines and as previously
announced, 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 was 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 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 a National Institute of Allergy and Infectious
Diseases (NIAID) funded grant. The OrbeShield™ program is
also the subject of a new $600,000 NIAID Small Business Innovation
Research (SBIR) grant supporting further evaluation as a treatment
for GI ARS.
For more details on the congress, please visit the official
congress web site:
http://timssnet2.allenpress.com/ECOMradressnet/common/tnt_frontpage.cfm
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 Gray (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.
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 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.
Past Releases
September 13, 2012 - Soligenix Announces Issuance of US Patent for
Topically Active Steroids to Treat Inflammatory Gastrointestinal
Disorders
September 6, 2012 - Soligenix Receives IND Clearance from FDA to
Initiate Clinical Program to Evaluate SGX203 as Therapy for
Pediatric Crohn’s Disease
September 4, 2012 - Soligenix Announces $300,000 NCI SBIR Grant
Award Supporting a Phase 2 Trial of orBec® as a
Treatment for Chronic GI GVHD
Company Contact
Joseph Warusz
Acting Chief Financial Officer
(609) 538-8200
Soligenix, Inc.
29 Emmons Drive
Suite C-10
Princeton, NJ 08540
www.soligenix.com
Posted: October 2012
