PRINCETON, N.J., April 9, 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 Pediatric Committee (PDCO) of
the European Medicines Agency (EMA) agreed to the Company's
Pediatric Investigation Plan (PIP) for SGX942 (dusquetide).
It was also agreed that the Company may defer conducting the PIP
until successful completion of its ongoing pivotal Phase 3 clinical
study evaluating SGX942 as a treatment for oral mucositis in
patients with head and neck cancer (HNC).
As part of the regulatory process for the registration of new
medicines in Europe,
pharmaceutical companies are required to provide a PIP outlining
their strategy for investigation of the new medicinal product in
the pediatric population. An approved PIP is a prerequisite for
filing a Marketing Authorization Application (MAA) for any new
medicinal product in Europe.
Soligenix will be able to file the adult indication MAA prior
to completion of the PIP because the PDCO permitted the Company to
defer conducting the pediatric program until the benefit/risk of
treatment has been established in the adult population.
Following a potential approval of the SGX942 MAA for treatment
of oral mucositis in adult patients with HNC, Soligenix will work
with PDCO and EMA to include appropriate pediatric data in the
approved labeling.
"PDCO's agreement that we may defer conducting our PIP, allowing
us to move forward with a potential submission and approval of an
MAA in adults while initiating the pediatric development program,
is an important step forward in our efforts to bring SGX942 to
market," stated Christopher J.
Schaber, PhD, President and Chief Executive Officer of
Soligenix. "Likewise, acceptance of our PIP is an important
regulatory milestone for the product, which also allows us to
potentially expand the label to include appropriate pediatric data.
Oral mucositis remains an extremely debilitating side effect
of cancer treatment and is particularly severe and prevalent in HNC
patients. Soligenix looks forward to continuing to work with
EMA and PDCO to bring this important therapy to the European market
as quickly as possible."
Soligenix is working with leading oncology centers to advance
dusquetide development with the conduct of a Phase 3 clinical trial
referred to as the "DOM–INNATE" study (Dusquetide treatment in Oral
Mucositis – by modulating INNATE immunity). Patient
recruitment is anticipated to be completed in 2019 with top-line
results available in the first half of 2020, pending the outcome of
the interim analysis in Q3 2019.
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.
Oral mucositis in HNC remains an area of unmet medical need
where there are currently no approved drug therapies.
About Dusquetide
Dusquetide (the active ingredient in SGX942) is an IDR, a new
class of short, synthetic peptides. It has a novel mechanism
of action whereby it modulates 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.
It also accelerates 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 has demonstrated safety in a Phase 1 clinical study in 84
healthy human volunteers. Positive efficacy results were
demonstrated in an exploratory Phase 2 clinical study in 111
patients with oral mucositis due to CRT for HNC. 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).
SGX942 has received Fast Track Designation from the FDA for the
treatment of oral mucositis as a result of radiation and/or
chemotherapy treatment in HNC patients, as well as Promising
Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare
Products Regulatory Agency for the treatment of severe oral
mucositis in HNC patients receiving CRT. In addition,
products containing the same active ingredient, dusquetide, have
been granted Fast Track Designation as an adjunctive therapy with
other antibacterial drugs, for the treatment of melioidosis and
Orphan Drug Designations in the treatment of MAS and the treatment
of acute radiation syndrome.
Soligenix has a strong intellectual property position in the IDR
technology platform, including composition of matter for dusquetide
and related analogs. Dusquetide was 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 nonclinical and clinical findings from the dusquetide
program 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 2 Clinical Study" at
http://dx.doi.org/10.1016/j.jbiotec.2016.10.010.
- "Dusquetide: Reduction in Oral Mucositis associated with
Enduring Ancillary Benefits in Tumor Resolution and Decreased
Mortality in Head and Neck Cancer Patients" at
https://doi.org/10.1016/j.btre.2017.05.002.
In addition, a high level review of the dusquetide 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 RiVaxÒ, that RiVaxÒ will be
approved for the PRV program or the amount for which a PRV
for RiVaxÒ 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.