PRINCETON, N.J.,
June 19, 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 final results from its SGX942 Phase 2 clinical trial
in oral mucositis on June 23, 2017 at
the Multinational Association for Supportive Care in Cancer (MASCC)
conference taking place in Washington,
DC from June 22 to 24,
2016.
SGX942 is the drug product using dusquetide, an Innate
Defense Regulator, for the treatment of oral mucositis. The
trial entitled "A Phase 2, double-blind, randomized,
placebo-controlled, dose-escalating, multicenter study of SGX942
for the attenuation of oral mucositis in patients being treated
with concomitant chemoradiation for the treatment of squamous cell
carcinoma of the head and neck", was completed in late 2016 and
was the first evaluation of dusquetide safety and efficacy in a
sick patient population. In this clinical trial that enrolled 111
patients, SGX942 (1.5 mg/kg dusquetide) demonstrated a positive,
clinically meaningful reduction in the median duration of severe
oral mucositis, ranging from 50% in all patients, to 67% in
patients receiving the most aggressive chemoradiation therapy (CRT)
for treatment of their head and neck cancer (HNC). In
addition to the oral mucositis findings, decreases in the bacterial
infection rate were observed with SGX942 treatment, along with an
increased incidence of "complete response" of tumor (i.e.,
disappearance) at the one month follow-up visit and a reduction in
opioid pain medication use. Recently published long-term follow-up
data indicate that the tumor resolution was enduring and, moreover,
that the mortality rate in the SGX942 1.5 mg/kg treatment group was
lower (p=0.08) than the placebo group over the 12 months following
completion of CRT. These data further support the safety and
tolerability of SGX942 in this patient population. Potential
ancillary benefits of utilizing SGX942 for the treatment of oral
mucositis include the reduction of infection, the accelerated tumor
resolution and the decreased mortality rate.
On the basis of these results, Soligenix has received US
Food and Drug Administration (FDA) clearance for, and European
Medicines Agency Scientific Advice on, a pivotal Phase 3 clinical
trial, anticipated to be initiated in 2017.
Key data from the Phase 2 study will be
presented.
Details of the Oral Presentation:
SGX942
is a Safe and Effective Treatment for Reducing the Duration of
Severe Oral Mucositis in HNC Patients presented by Dr. Oreola
Donini, Chief Scientific Officer and attended by Dr. Richard Straube, Chief Medical Officer on
June 23, 2016 at 6:10 pm. The abstract is available
here.
About the MASCC Conference
"The Multinational Association of Supportive Care in
Cancer (MASCC) is an international multidisciplinary organization
dedicated to research, practice, and education in all aspects of
supportive care for people with cancer, regardless of the stage of
their disease. Founded in 1990, MASCC now includes members
from more than 60 countries and 5 continents." Details on the
MASCC society can be found at
http://www.mascc.org/. The annual meeting
is alternately held on various continents. This year's
conference, held in conjunction with International Society of Oral
Oncology in Washington DC, will
feature plenary sessions on financial toxicity, precision medicine,
and immunotherapy side effects.
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 chemoradiation therapy 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 SGX942
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 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.