FDA Grants Soligenix Fast Track Designation for OrbeShield(TM) for
the Reduction of Mortality Associated with Gastrointestinal Acute
Radiation Syndrome (GI ARS)
PRINCETON, N.J., Jan. 29, 2013 /PRNewswire/ -- Soligenix,
Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage
biopharmaceutical company, announced today that its
OrbeShieldTM (oral beclomethasone 17,21-dipropionate or
oral BDP) development program for the treatment of GI ARS has
received "Fast Track" designation from the U.S. Food and Drug
Administration (FDA). Soligenix has also previously received Orphan
Drug designation from the FDA for oral BDP for the prevention of
death following a potentially lethal dose of total body irradiation
during or after a radiation disaster.
Fast track is a designation that the FDA reserves for a drug
intended to treat a serious or life- threatening condition and one
that demonstrates the potential to address an unmet medical need
for the condition. Fast track designation is designed to facilitate
the development and expedite the review of new drugs. For instance,
should events warrant, Soligenix will be eligible to submit a new
drug application (NDA) for OrbeShieldTM on a rolling
basis, permitting the FDA to review sections of the NDA prior to
receiving the complete submission. Additionally, NDAs for
fast track development programs ordinarily will be eligible for
priority review, which imparts an abbreviated review time of six
months.
"There are no FDA approved therapies for the treatment of GI
ARS," stated Christopher J. Schaber,
PhD, President & Chief Executive Officer of Soligenix. "The
FDA's action in granting fast track designation is a validation of
BDP's potential to address this life-threatening, unmet medical
need. We look forward to working closely with the FDA, as
well as with the National Institute of Allergy and Infectious
Disease (NIAID) and the Biomedical Advanced Research and
Development Authority (BARDA) to potentially expedite the
OrbeShieldTM development program."
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 has the potential
to be rescued by bone marrow transplantation or growth factor
administration, there is no established treatment or preventive
measure for the GI damage that results from high-dose radiation
exposure. Therefore, there is an urgent need to develop specific
medical countermeasures against the lethal pathophysiological
manifestations of radiation-induced GI injury.
About OrbeShieldTM
OrbeShieldTM contains BDP, a highly potent, topically
active corticosteroid that has a local effect on inflamed tissue.
OrbeShieldTM 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 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
$600,000 NIAID Small Business
Innovation Research (SBIR) grant. OrbeShieldTM 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.