PRINCETON, N.J., March 27, 2013 /PRNewswire/ -- Soligenix,
Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage
biopharmaceutical company, announced today that the Food and Drug
Administration (FDA) has completed its review and cleared the
Investigational New Drug (IND) application for SGX942 for the
treatment of oral mucositis resulting from radiation and/or
chemotherapy treatment in head and neck cancer patients. Clearance
of the IND allows Soligenix to initiate a Phase 2, randomized,
double-blind, placebo-controlled, dose-escalating clinical study of
SGX942 in patients being treated for head and neck cancer.
The trial is expected to be initiated in the second half of
2013.
"Oral mucositis is a significant unmet medical need which
ultimately impacts the tolerability of radiation and chemotherapy
and therefore the survivability of cancer," stated Stephen T Sonis,
DMD, DMSc, Clinical Professor of Oral Medicine at Harvard School of Dental Medicine and a Member of
the Soligenix Oral Mucositis Medical Advisory Board. "The
lack of an effective treatment has frustrated healthcare providers
and caused misery for innumerable patients. As an innate defense
regulator (IDR), SGX942 directly targets a fundamental biological
mechanism which leads to mucosal injury caused by radiation and
chemotherapy."
"We are pleased that the FDA has cleared Soligenix's first IND
for the recently acquired IDR technology," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "The initiation of the oral
mucositis clinical program marks an important next step in the
development of SGX942. We look forward to working with our
esteemed Medical Advisory Board and clinical investigators to
initiate this clinical study."
About SGX942
SGX942 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. SGX942 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. SGX942 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 inclusive of government
grants.
About Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by
anticancer therapies (e.g., radiation or chemotherapy). It
can occur in any mucosal region, but is most commonly associated
with the mouth, followed by the small intestine. Mucositis affects
approximately 500,000 people in the US per year and occurs in 40%
of patients receiving chemotherapy. Mucositis can be severely
debilitating and can lead to infection, sepsis, the need for
parenteral nutrition and narcotic analgesia. The gastrointestinal
damage causes severe diarrhea. These symptoms can limit the doses
and duration of cancer treatment, leading to sub-optimal treatment
outcomes. The mechanisms of mucositis have been extensively
studied and have been recently linked to the interaction of
chemotherapy and/or radiation therapy with the innate defense
system. Bacterial infection of the ulcerative lesions is now
regarded as a secondary consequence of dysregulated local
inflammation triggered by therapy-induced cell death, rather than
as the primary cause of the lesions.
Oral mucositis is a subpopulation of approximately 90,000
patients in the US, with a comparable number in Europe. Oral
mucositis almost always occurs in patients with head and neck
cancer treated with radiation therapy (>80% incidence of severe
mucositis) and is common (40-100% incidence) in patients undergoing
high dose chemotherapy and hematopoietic cell transplantation,
where the incidence and severity of oral mucositis depends greatly
on the nature of the conditioning regimen used for
myeloablation.
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 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," "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 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.