PRINCETON, N.J., Aug. 1, 2014 /PRNewswire/ -- Soligenix, Inc.
(OTCQB: SNGX) (Soligenix or the Company), a clinical stage
biopharmaceutical company focused on developing products to treat
serious inflammatory diseases where there remains an unmet medical
need, as well as developing several biodefense vaccines and
therapeutics, announced today that the National Institute of
Allergy and Infectious Diseases (NIAID) has exercised its option to
advance preclinical development of OrbeShieldTM (oral
beclomethasone 17,21-dipropionate or oral BDP). The 12-month
option provides an additional $2.1
million to Soligenix to advance OrbeShield™ as a medical
countermeasure (MCM) for the treatment of gastrointestinal acute
radiation syndrome (GI ARS). NIAID granted an initial award of
$2.1 million to Soligenix on
September 18, 2013. The total
contract award is valued at up to $6.4
million over three years.
Soligenix's GI ARS program is supported by contract awards from
both the Biomedical Advanced Research Development Authority (BARDA)
and NIAID, totaling up to approximately $32
million. In addition to developing oral BDP as a MCM,
the company is also pursuing oral BDP as a treatment for GI
inflammation in pediatric Crohn's disease, acute radiation
enteritis and chronic Graft-versus-Host disease (cGVHD).
"The execution of the first option reflects NIAID's ongoing
commitment to developing MCMs for GI ARS and the compelling nature
of Soligenix's OrbeShield™ product," stated Christopher J. Schaber, PhD, President &
Chief Executive Officer of Soligenix. "This continued
funding, plus the BARDA contract awarded last year, 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 in GI ARS. We
thank NIAID for their past and present support and look forward to
continuing our close collaboration 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, people exposed to radiation levels
greater than 2 Gy are at high risk of developing ARS. Exposure to
high doses of radiation exceeding 10 to 12 Gy causes acute GI
injury, which can result in death in 5 to 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
total body irradiation. Although hematopoietic ARS 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 consequences of radiation-induced GI injury.
About OrbeShield™
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 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
for use in other GI disorders characterized by severe inflammation
such as pediatric Crohn's disease, radiation enteritis and
cGVHD.
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.
OrbeShield™ development as an MCM for GI ARS is currently being
supported by BARDA and NIAID contracts valued up to $26.3 million and $6.4
million, respectively.
About Soligenix, Inc.
Soligenix is a clinical stage biopharmaceutical company focused
on 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 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
$26.3 million and a NIAID contract
award valued up to $6.4 million.
OrbeShield™ has previously demonstrated statistically significant
preclinical survival results in a canine model of GI ARS funded by
NIAID. Additionally, Soligenix has an exclusive worldwide
collaboration with Intrexon Corporation (NYSE: XON) focused on the
joint development of a treatment for Melioidosis, a high priority
biothreat and an area of unmet medical need.
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 requirements,
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.