PRINCETON, N.J., May 28, 2019 /PRNewswire/ -- Soligenix, Inc.
(Nasdaq: SNGX) (Soligenix or the Company), a late-stage
biopharmaceutical company focused on developing and commercializing
products to treat rare diseases where there is an unmet medical
need, announced today that Soligenix will be participating in a
biodefense contract for the development of medical countermeasures
against bacterial threat agents, with Soligenix awarded a
subcontract of approximately $600,000
over 3 years.
Innate Defense Regulators (IDRs) regulate the innate immune
system to simultaneously reduce inflammation, eliminate infection
and enhance tissue healing. 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 including both antibiotic sensitive and
resistant strains, as well as accelerating resolution of tissue
damage following exposure to a variety of agents including
bacterial pathogens, trauma and chemo- or radiation-therapy. IDRs
are also effective in conjunction with antibiotics, enhancing
efficacy of sub-optimal antibiotic regimens and reducing the
required antibiotic dose, thereby potentially minimizing the
generation of antibiotic resistance. Soligenix has previously
reported the results of a Phase 2 clinical study using dusquetide,
its lead IDR, in the treatment of oral mucositis in head and neck
cancer patients undergoing chemoradiation therapy. In
addition to demonstrating a reduction in the median duration of
severe oral mucositis in these patients, dusquetide treatment was
also associated with a reduced incidence of reported
infections. A pivotal Phase 3 multinational study in oral
mucositis is currently underway in the U.S. and Europe, with an interim analysis expected in
the September 2019 timeframe.
The proposed work will further evaluate the efficacy of the IDR
platform in animal models of disease caused by bacterial biothreat
agents, such as B. pseudomallei and F. tularensis,
among others. Previous animal studies have demonstrated efficacy
against B. pseudomallei infection.
About Bacterial Threat Agents
Bioterrorism agents are characterized by the Centers for Disease
Control and Prevention (CDC) as having significant potential to be
utilized as a biowarfare weapon. The classification is based on the
ease of dissemination and the potential consequent impact on
society. Such diseases can be caused by viruses, bacteria and
toxins. Bacterial threat agents, including Bacillus
anthracis (Anthrax), Burkholderia mallei (Glanders),
Burkholderia pseudomallei (Melioidosis), Francisella
tularensis (Tularemia), Yersinia pestis (Plague) and
Coxiella burnetti (Q-fever) and are considered either
Category A (high priority) or B (second priority) threat agents.
More information can be found at the CDC website.
About Innate Defense Regulators
IDRs are a new class of short, synthetic peptides. They
have a novel mechanism of action whereby they modulate the body's
reaction to both injury and infection towards an anti-inflammatory,
anti-infective and tissue healing response. IDRs have no
direct antibiotic activity but, by modulating the host's innate
immune system responses, increase survival after infections caused
by a broad range of bacterial Gram-negative and Gram-positive
pathogens. They also accelerate resolution of tissue damage
following exposure to a variety of agents including bacterial
pathogens, trauma and chemo- and/or radiation therapy.
Preclinical efficacy and safety has been demonstrated in numerous
animal disease models including mucositis, colitis, macrophage
activation syndrome (MAS) as well as bacterial infections,
including melioidosis.
SGX942 (the lead clinical IDR candidate containing the active
ingredient dusquetide) has demonstrated safety in a Phase 1
clinical study in 84 healthy human volunteers. Positive efficacy
results were demonstrated in a Phase 2 clinical study in 111
patients with oral mucositis due to chemoradiation therapy for head
and neck cancer. Soligenix is working with leading oncology
centers in the US and Europe to
advance SGX942 in oral mucositis with the conduct of a pivotal
Phase 3 clinical trial referred to as the "DOM–INNATE" study
(Dusquetide treatment in Oral Mucositis – by modulating INNATE
immunity).
Soligenix has a strong intellectual property position in the IDR
technology platform, including composition of matter for dusquetide
and related analogs. IDRs were developed pursuant to
discoveries made by Professors B. Brett
Finlay, PhD and Robert
Hancock, PhD of the University of
British Columbia, Canada. Soligenix has received partial
funding from NIH for its oral mucositis clinical studies. The
Phase 2 study was supported with a Phase I SBIR grant
(#R43DE024032) award, with the Phase 3 study being supported by a
Phase II SBIR grant (#R44DE024032) award.
Key findings can be found in the following publications:
- "Targeting Innate Immunity to Treat Disease: Potential
Therapeutic Applications" at
https://www.drugtargetreview.com/article/37410/targeting-innate-immunity/.
- "A novel approach for emerging and antibiotic resistant
infections: Innate defense regulators as an agnostic therapy" at
http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.
In addition, a high level review of the IDR technology platform
is available here.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on
developing and commercializing products to treat rare diseases
where there is an unmet medical need. Our BioTherapeutics business
segment is developing SGX301 as a novel photodynamic therapy
utilizing safe visible light for the treatment of cutaneous T-cell
lymphoma, our first-in-class innate defense regulator (IDR)
technology, dusquetide (SGX942) for the treatment of oral mucositis
in head and neck cancer, and proprietary formulations of oral
beclomethasone 17,21-dipropionate (BDP) for the
prevention/treatment of gastrointestinal (GI) disorders
characterized by severe inflammation including pediatric Crohn's
disease (SGX203) and acute radiation enteritis (SGX201).
Our Vaccines/BioDefense business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate and SGX943, our therapeutic candidate for antibiotic
resistant and emerging infectious disease. The development of our
vaccine programs incorporates the use of our proprietary heat
stabilization platform technology, known as
ThermoVax®. To date, this business segment has
been supported with government grant and contract funding from the
National Institute of Allergy and Infectious Diseases (NIAID) and
the Biomedical Advanced Research and Development Authority
(BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at www.soligenix.com.
This press release may contain 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," "hopes,"
"intends," "plans," "expects," "goal," "may," "suggest," "will,"
"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 therapeutics and vaccines
against bioterror threats, conducting preclinical and clinical
trials of therapeutics and vaccines, obtaining regulatory approvals
and manufacturing therapeutics and 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 U.S.
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 U.S. Congress may not pass any legislation that would provide
additional funding for the Project BioShield program. In addition,
there can be no assurance as to timing or success of the Phase 3
clinical trial of SGX942 (dusquetide) as a treatment for oral
mucositis in patients with head and neck cancer receiving
chemoradiation therapy or the Phase 3 clinical trial of SGX301
(synthetic hypericin) for the treatment of cutaneous T-cell
lymphoma. There also can be no assurance as to timing or
success of the preclinical/clinical trials
of RiVax®,
that RiVax® will be approved for the
PRV program or the amount for which a PRV
for RiVax® can be sold.
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.
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SOURCE Soligenix, Inc.