PRINCETON, N.J., Aug. 15, 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 the National Institute of Dental and
Craniofacial Research (NIDCR), part of the National Institutes of
Health (NIH), has awarded Soligenix a Phase I Small Business
Innovation Research (SBIR) of approximately $150,000 to support the evaluation of SGX942
(dusquetide) in pediatric indications. This award will
facilitate the assessment of SGX942 safety in juvenile animals,
supporting future studies in pediatric populations, including oral
mucositis indications in pediatric patients undergoing stem cell
transplants and treatments for head and neck cancer.
Innate Defense Regulators (IDRs) regulate the innate immune
system to simultaneously reduce inflammation, eliminate infection
and enhance tissue healing. Dusquetide is Soligenix's lead
clinical IDR candidate. 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.
Soligenix has previously reported the results of a Phase 2 clinical
study using dusquetide in the treatment of oral mucositis in head
and neck cancer (HNC) patients undergoing chemoradiation therapy
(CRT). 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 and an increased rate of tumor resolution. A
pivotal, Phase 3, multinational study in oral mucositis is
currently underway in the US and Europe, with an interim analysis expected in
the September 2019 timeframe.
"We are appreciative of the continued support provided by NIDCR
for the SGX942 development program," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "We believe this SBIR grant award
further validates dusquetide's novel mechanism of action, as well
as the positive clinical data generated to date. Oral mucositis
remains an extremely debilitating side effect of cancer treatment
in both adults and children. This funding will allow us to
further evaluate the safety of IDRs in juvenile animals, allowing
for the conduct of pediatric clinical studies, and the potential to
expand future use in the pediatric patient population.
About Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by
anticancer therapies. It can occur in any mucosal region, but
is most commonly associated with the mouth, followed by the small
intestine. It is estimated, based upon review of historic
published studies and reports and an interpolation of data on the
incidence of mucositis, that 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.
It is estimated, based upon review of historic published studies
and reports and an interpolation of data on the incidence of oral
mucositis, that oral mucositis in HNC 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 HNC treated with CRT and is severe, causing inability to eat
and/or drink, in >80% of patients. It 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.
In the pediatric population, head and neck cancer is a rarer
occurrence and is caused by different underlying pathologies.
The major types of HNC in children are lymphoma, sarcomas
(including rhabdomyosarcomas), and neuroblastoma rather than
squamous cell carcinoma, the major type of adult HNC cancers.
Hematopoietic stem cell
transplantation (HSCT), especially allogeneic
transplantation with higher risk of oral mucositis, is more
frequently used in the pediatric population than in adults when
treating a number of primary tumor types, as seen
in leukemia and lymphoma. Both treatment of HNC and
HSCT are associated with high risk of oral mucositis in the
pediatric population.
Oral mucositis remains an area of unmet medical need where there
are currently no approved drug therapies in the context of any
solid tissue tumors.
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. In addition, support for
pediatric studies, including a juvenile toxicology study, has
also been provided by a Phase I SBIR grant (#R43DE028769).
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 .
- "Dusquetide: A novel innate defense regulator demonstrating a
significant and consistent reduction in the duration of oral
mucositis in preclinical data and a randomized, placebo-controlled
phase 2a clinical study" at
https://www.sciencedirect.com/science/article/pii/S0168165616315668
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 Specialized
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 Public Health Solutions 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.