PRINCETON, N.J., Feb. 11, 2020 /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 Dr. Brian Poligone, clinical investigator and lead
enroller in the pivotal Phase 3 FLASH (Fluorescent Light Activated
Synthetic Hypericin) study evaluating SGX301 in the treatment of
early stage cutaneous T-cell lymphoma (CTCL), will present a
patient case study from the trial. The presentation will be
given at the upcoming 4th World Congress of Cutaneous
Lymphomas on February 12-14, in
Barcelona, Spain.
Oral Presentation:
Response in a patient with refractory folliculotropic
mycosis fungoides to a topical hypericin ointment activated with
fluorescent light presented by Brian Poligone, MD, PhD, an Investigator in the
FLASH study and Director of the Rochester Skin Lymphoma Medical
Group, Fairport, NY, USA, on
February 13th, 2020 at 8:00 AM CET. Abstract will be available on
corporate website following the conference.
Folliculotropic mycosis fungoides (FMF) is a type of CTCL that
is very difficult to treat. FMF is generally considered more
severe and aggressive than other types of CTCL due to its greater
risk of disease progression and worse prognosis. Treatment
usually includes early consideration of systemic therapies, as
topical therapies are often not beneficial. The presented
case study focuses on a single patient with FMF who has completed
the Phase 3 FLASH trial, including the open-label cycles and
6-month follow-up. The patient had previously failed at least
five therapies, including topical treatments, oral medications and
phototherapy. While in the study, the patient received at
least 12 weeks of SGX301 treatment and experienced significant
improvement, eventually leading to complete clearance of disease
that has been sustained for at least 4 years.
"I'm happy to be presenting this important case study at the
world congress," stated Dr. Brian
Poligone, Director of the Rochester Skin Lymphoma
Group. "This patient community needs safe, skin directed
therapies to treat this difficult lymphoma and I'm very excited
that SGX301 may be one such therapy. I know I can speak for
the other clinical study sites participating in the FLASH study,
when I say, we are eager for the topline results this quarter."
About the 4th World Congress of Cutaneous
Lymphomas
The 4th World Congress is designed to promote the exchange of
scientific ideas and foster interactions between physicians,
researchers and anyone engaged in the field of cutaneous lymphomas.
The program will include discussions of basic, translational and
clinical research and discuss new developments in the diagnosis,
practice and management of cutaneous lymphomas. More information
about the Congress is found here and the final programme is
available here.
About SGX301
SGX301 is a novel first-in-class photodynamic therapy utilizing
safe visible light for activation. The active ingredient in
SGX301 is synthetic hypericin, a potent photosensitizer that is
topically applied to skin lesions, is taken up by the malignant
T-cells, and then activated by fluorescent light 16 to 24 hours
later. This treatment approach avoids the risk of secondary
malignancies (including melanoma) inherent with the frequently
employed DNA-damaging chemotherapeutic drugs and other photodynamic
therapies that are dependent on ultraviolet exposure.
Combined with photoactivation, hypericin has demonstrated
significant anti-proliferative effects on activated normal human
lymphoid cells and inhibited growth of malignant T-cells isolated
from CTCL patients. In a published Phase 2 clinical study in
CTCL, patients experienced a statistically significant (p ≤ 0.04)
improvement with topical hypericin treatment whereas the placebo
was ineffective: 58.3% compared to 8.3%,
respectively.
The Phase 3 FLASH trial enrolled 169 patients with Stage IA, IB
or IIA CTCL. Enrollment of the trial is completed and topline
primary endpoint results are expected to be available in Q1 2020.
The trial consists of three treatment cycles, each of 8 weeks
duration. Treatments are administered twice weekly for the
first 6 weeks and treatment response is determined at the end of
Week 8. In the first treatment cycle, approximately 107
subjects receive SGX301 treatment (0.25% synthetic hypericin) and
53 receive placebo treatment of their index lesions. In the
second cycle, all subjects receive SGX301 treatment of their index
lesions and in the third (optional) cycle all subjects receive
SGX301 treatment of all their lesions. Subjects are followed
for an additional 6 months after the completion of treatment.
The majority of patients enrolled have elected to continue with the
optional, open-label component of the study.
The Phase 3 CTCL clinical study was partially funded with this
NCI Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix,
Inc.
SGX301 has received orphan drug and fast track designations from
the US Food and Drug Administration (FDA), as well as orphan
designation from the European Medicines Agency (EMA).
About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of
cancer of the white blood cells that are an integral part of the
immune system. Unlike most NHLs which generally involve
B-cell lymphocytes (involved in producing antibodies), CTCL is
caused by an expansion of malignant T-cell lymphocytes (involved in
cell-mediated immunity) normally programmed to migrate to the
skin. These malignant cells migrate to the skin where they
form various lesions, typically beginning as a rash and eventually
forming raised plaques and tumors as the disease progresses.
Mortality is related to the stage of CTCL, with median survival
generally ranging from about 12 years in the early stages to only
2.5 years when the disease has advanced. There is currently no cure
for CTCL. Typically, CTCL lesions are treated and regress but
usually return either in the same part of the body or in new
areas.
CTCL constitutes a rare group of NHLs, occurring in about 4% of
the approximate 700,000 individuals living with the disease.
It is estimated, based upon review of historic published studies
and reports and an interpolation of data on the incidence of CTCL
that it affects over 25,000 individuals in the US, with
approximately 3,000 new cases seen annually.
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, 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), the
Defense Threat Reduction Agents (DTRA) 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 US
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 US 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 (including the outcome of the interim
analysis) or the Phase 3 clinical trial of SGX301 (synthetic
hypericin) for the treatment of cutaneous T-cell lymphoma.
Further, there can be no assurance that RiVax® will
qualify for a biodefense Priority Review Voucher (PRV) or that the
prior sales of PRVs will be indicative of any potential sales price
for a PRV for RiVax®. 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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