Soligenix Awarded NIAID Contract Valued up to $6.4 Million for the Development
of OrbeShield™ in GI ARS
PRINCETON, N.J., Sept. 25, 2013
PRINCETON, N.J., Sept.25, 2013 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a clinical stage biopharmaceutical company focused
on developing products to treat inflammatory diseases and biodefense medical
countermeasures (MCMs) where there remains an unmet medical need, announced
today that it has been awarded a contract valued at up to $6.4 million by the
US Department of Health and Human Service's National Institutes of Health
(NIH) (specifically funded by the National Institute of Allergy and Infectious
Diseases or NIAID). The contract is for the advanced preclinical development
of OrbeShield™ (oral beclomethasone 17,21-dipropionate or oral BDP) as a MCM
for the treatment of gastrointestinal acute radiation syndrome (GI ARS).
The potential three year contract contains a one year base period, with two
contract options that would extend the contract an additional year each. The
total award will support the development activities necessary to evaluate
OrbeShield™ as a potential MCM to treat GI ARS.
"Securing this highly competitive NIH contract provides further recognition as
to the innovative quality and potential therapeutic impact of our technology,"
stated Christopher J. Schaber, PhD, President & Chief Executive Officer of
Soligenix. "This contract award, in addition to the BARDA contract award
recently received, has the potential to provide the necessary funding to
advance the development of OrbeShield™ while building upon the scientific
evidence supporting its use as a potential MCM for GI ARS. We thank NIAID for
their past and present support and look forward to collaborating closely with
them as we advance this technology."
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 MCMs against
the lethal pathophysiological manifestations of radiation-induced GI injury.
OrbeShield™ is formulated for oral administration in GI ARS patients as a
single product consisting of two tablets; one tablet releases BDP in the
proximal portions of the GI tract and the other tablet releases BDP in the
distal portions of the GI tract. BDP has been marketed in the US and
worldwide since the early 1970s as the active pharmaceutical ingredient in
inhalation products for the treatment of patients with allergic rhinitis and
asthma. To date, oral BDP has been safely administered to more than 350 human
subjects in multiple clinical studies. Oral BDP is also being developed in
other GI disorders characterized by severe inflammation such as pediatric
Crohn's disease, radiation enteritis and chronic Graft-versus-Host disease
The FDA has cleared the Investigational New Drug (IND) application for
OrbeShield™ for the mitigation of morbidity and mortality associated with GI
ARS. OrbeShield™has also been granted Orphan Drug and Fast Track
designations by the FDA for the prevention of death following a potentially
lethal dose of total body irradiation during or after a radiation disaster.
In addition, OrbeShield™ was recently awarded a contract valued up to $26.3M
by the US Department of Health and Human Service's Biomedical Advanced
Research and Development Authority (BARDA).
The National Institute of Allergy and Infectious Diseases conducts and
supports basic and applied research to better understand, treat, and
ultimately prevent infectious, immunologic, and allergic diseases. For more
than 60 years, NIAID research has led to new therapies, vaccines, diagnostic
tests, and other technologies that have improved the health of millions of
people in the US and around the world.
About Soligenix, Inc.
Soligenix is a clinical stage biopharmaceutical company developing products to
treat serious inflammatory diseases where there remains an unmet medical need,
as well as developing several biodefense vaccines and therapeutics. Soligenix
is developing proprietary formulations of oral BDP (beclomethasone
17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders
characterized by severe inflammation, including pediatric Crohn's disease
(SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host
disease (orBec^®), as well as developing its novel innate defense regulator
(IDR) technology SGX942 for the treatment of oral mucositis.
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 BARDA contract
award valued up to $26.3M and a $600,000 NIAID Small Business Innovation
Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically
significant preclinical survival results in a canine model of GI ARS funded by
the NIAID. Recently, Soligenix announced a worldwide exclusive collaboration
with Intrexon Corporation that will focus on the joint development of a
treatment for Melioidosis, a high priority biothreat and an area of unmet
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, including but not limited to, potential market sizes,
patient populations and clinical trial enrollment. Statements that are not
historical facts, such as "anticipates," "estimates," "believes," "intends,"
"potential," 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,
achieve regulatory approval for or commercialize products based on its
technologies, particularly in light of the significant uncertainty inherent in
developing vaccines against bioterror threats conducting preclinical and
clinical trials of vaccines, obtaining regulatory approvals and manufacturing
vaccines, 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 funding to
support product development and commercialization efforts, including 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, that it will be able to compete with larger and better
financed competitors in the biotechnology industry, that changes in health
care practice, third party reimbursement limitations and Federal and/or state
health care reform initiatives will not negatively affect its business, 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.
Contact: Joe Warusz, CPA, Acting Chief Financial Officer, (609) 538-8200,
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