PRINCETON, N.J., July 6, 2017 /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 it will be presenting an overview of its
SGX94 (dusquetide) technology platform on July 13, 2017 at the Drug Discovery and Therapy
World Congress (DDTWC) taking place in Boston, MA from July 10
- 13, 2017. The presentation will address dusquetide's novel
mechanism of anti-inflammatory, anti-infective and tissue-healing
action, as well as final results from its SGX942 Phase 2 clinical
trial in oral mucositis.
Details of the Oral Presentation:
Modulation of Innate Immunity in the Treatment of
Inflammation-Driven and Infection-Driven Disease presented by Dr.
Oreola Donini, Chief Scientific Officer on July 13, 2017 at 1:45
pm. The abstract is available here.
Dusquetide is an Innate Defense Regulator (IDR) and the active
ingredient in the drug SGX942, which yielded positive results in a
Phase 2 clinical trial in oral mucositis. In that trial, a
significant decrease in the duration of severe oral mucositis was
observed, reflecting the anti-inflammatory and tissue-healing
aspects of the dusquetide mechanism of action. In the same trial, a
significant decrease in the rate of infections was also observed in
the group treated with SGX942, a finding that is consistent with
preclinical data supporting the broad-spectrum activity of IDRs in
the treatment of bacterial infections. The IDRs leverage a
unique mechanism of action, acting at a key intracellular
convergence point in the innate immune pathways, facilitating a
multi-dimensional impact on the response of the innate immune
system to any stimulus, ameliorating tissue damage and increasing
survival following exposure to a variety of agents, including a
broad range of bacterial pathogens, trauma and radiation or
chemotherapy. Soligenix is initially developing dusquetide for the
treatment of oral mucositis in patients with head and neck cancer,
where a pivotal Phase 3 clinical trial has recently been initiated
to begin patient enrollment.
About the DDTWC Conference
"This conference aims to span the interdisciplinary fields of
pre-clinical and clinical drug discovery and drug therapy and to
highlight the burgeoning fields of Translational Medicine - and the
major advances from "bench to bedside" research and
practice." Details on the DDTWC can be found at
http://www.ddtwc.com/.
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 and an anti-infective
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, melioidosis, macrophage activation syndrome
(MAS) and other bacterial infections. Some of these
preclinical findings have been published in an article entitled "A
novel approach for emerging and antibiotic resistant infections:
Innate defense regulators as an agnostic therapy," available at the
following link:
http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.
SGX942 has demonstrated safety in a Phase 1 clinical study in 84
healthy human volunteers. Recently, SGX942 had positive
results in an exploratory Phase 2 clinical study in 111 patients
with oral mucositis due to chemoradiation therapy (CRT) for
HNC. Consistent with preclinical findings, SGX942 at a dose
of 1.5 mg/kg demonstrated positive improvements in decreasing the
duration of severe oral mucositis by 50% overall compared to the
placebo group, from 18 days to 9 days (p=0.099). In patients
at the highest risk of developing severe oral mucositis (i.e.,
those receiving concomitant cisplatin chemotherapy of 80-100
mg/m2 every third week), the reduction in the duration
of severe oral mucositis was even more significant at 67% when
treated with SGX942 1.5 mg/kg, from 30 days to 10 days
(p=0.04). The p-values met the prospectively defined
statistical threshold of p<0.1 in the study protocol.
Additional observations included an improved tumor response to CRT
at the one month follow-up visit, as well as decreases in mortality
and infection rate. The study results are reviewed in
"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," published online in the Journal of
Biotechnology and available at the following link:
http://dx.doi.org/10.1016/j.jbiotec.2016.10.010.
Long-term (12 month) follow-up data further indicated the safety
and tolerability of SGX942 treatment, with a sustained trend
towards reduced mortality and increased tumor resolution in the 1.5
mg/kg SGX942 treatment group compared to the placebo group.
Opioid pain medication use was also seen to decrease over the
course of CRT in the 1.5 mg/kg SGX942 treatment group at the point
of highest oral mucositis risk, while it increased in the placebo
group. Detailed clinical results from the Phase 2 study, as
well as a review of the pathogenesis of oral mucositis and the
mechanism of action of SGX942, are discussed here. The long-term
follow-up results from the Phase 2 study are reviewed in,
"Dusquetide: Reduction in Oral Mucositis associated with Enduring
Ancillary Benefits in Tumor Resolution and Decreased Mortality in
Head and Neck Cancer Patients", published online in
Biotechnology Reports and available at the following link:
https://doi.org/10.1016/j.btre.2017.05.002.
The Phase 2 oral mucositis clinical study was partially funded
with a grant from the National Institute of Dental and Craniofacial
Research Small Business Innovation Research grant #1R43 DE024032-01
(Soligenix, Inc.).
Drug products containing dusquetide have also received Fast
Track Designations from the FDA for the treatment of oral mucositis
as a result of radiation and/or chemotherapy treatment in HNC
patients, and as an adjunctive therapy with other antibacterial
drugs, for the treatment of melioidosis. Orphan Drug Designations
for use of dusquetide in the treatment of MAS as well as for the
treatment of acute radiation syndrome have also been granted. In
addition, dusquetide has been granted 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.
Dusquetide and related analogs have a strong intellectual
property position, including composition of matter.
Dusquetide was developed pursuant to discoveries made by Professors
B. Brett Finlay, PhD and
Robert Hancock, PhD of the
University of British Columbia,
Canada.
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, OrbeShield®, our GI acute radiation syndrome
therapeutic 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 the 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 and the Phase 3 clinical trial of SGX301
(synthetic hypericin) for the treatment of cutaneous T-cell
lymphoma. 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.