FDA Grants Soligenix Orphan Drug Designation for SGX94 for Treatment of Acute Radiation Syndrome

FDA Grants Soligenix Orphan Drug Designation for SGX94 for Treatment of Acute
                              Radiation Syndrome

PR Newswire

PRINCETON, N.J., Sept. 16, 2013

PRINCETON, N.J., Sept. 16, 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
countermeasures where there remains an unmet medical need, announced today
that the Office of Orphan Products Development of the US Food and Drug
Administration (FDA) has granted orphan drug designation to the active
ingredient SGX94 for the treatment of acute radiation syndrome (ARS). SGX94
is an innate defense regulator (IDR), a new class of short, synthetic peptides
that accelerates resolution of tissue damage following exposure to a variety
of agents including bacterial pathogens, trauma, radiation and/or
chemotherapy.

The US Orphan Drug Act is intended to assist and encourage companies to
develop safe and effective therapies for the treatment of rare diseases and
disorders. In addition to providing a seven year term of market exclusivity
upon final FDA approval, orphan drug designation also positions Soligenix to
be able to leverage a wide range of financial and regulatory benefits,
including government grants for conducting clinical trials, waiver of
expensive FDA user fees for the potential submission of a New Drug
Application, and certain tax credits.

"The FDA's decision to grant SGX94 orphan drug designation signifies an
important step for Soligenix as we continue to expand our biodefense pipeline
and the many potential applications of our novel IDR technology," stated
Christopher J. Schaber, PhD, President & Chief Executive Officer of
Soligenix. "SGX94's activity in preclinical models has demonstrated the
potential to mitigate damage to the skin and gastrointestinal tract, as well
as enabling clearance of infection as a result of damage to the hematopoietic
system, all of which occur with varying severity in ARS. The marketing
exclusivity that orphan drug designation imparts adds significantly to the
existing patent estate surrounding SGX94."

About ARS

ARS occurs after toxic radiation exposure and involves several organ systems,
notably the skin, the bone marrow and the gastrointestinal (GI) tract. 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. The chance of survival for people with ARS decreases with
increasing radiation dose, with doses of 10-12 Gy causing death within 15 days
and lower doses potentially causing death within a few months. The cause of
death within 15 days of radiation exposure is usually damage to the GI tract
whereas after 15 days death usually is a consequence of bone marrow
(hematopoietic) injury. Symptoms of cutaneous (skin) radiation injury are
recurring phenomena after ARS. For the survivors, the recovery process may
last from several weeks up to two years. Although the hematopoietic syndrome
may be rescued by bone marrow transplantation or growth factor administration,
the risk of death due to infection remains very high. There is currently no
established treatment or preventive measure for the GI damage that occurs
after high-dose radiation.

About SGX94

SGX94 is an IDR, a new class of short, synthetic peptides that has a novel
mechanism of action in that it has simultaneous anti-inflammatory and
anti-infective activity. IDRs have no direct antibiotic activity but modulate
host responses, increasing survival after infections with a broad range of
bacterial Gram-negative and Gram-positive pathogens, as well as accelerating
resolution of tissue damage following exposure to a variety of agents
including bacterial pathogens, trauma and chemo- and/or radiation-therapy.
SGX94 has demonstrated safety in a Phase 1 clinical study in healthy human
volunteers and efficacy in numerous animal disease models including mucositis,
colitis, skin infection and other bacterial infections. SGX94 was developed
pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert
Hancock, PhD of the University of British Columbia, Canada and approximately
$40 million has been put towards its development to date, inclusive of
government grants. SGX94, the active ingredient in SGX942, is also in
clinical development for the treatment of oral mucositis.

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 $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 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 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,
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.

Website: http://www.soligenix.com
Contact: Joe Warusz, CPA, Acting Chief Financial Officer, (609) 538-8200,
www.soligenix.com
 
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