PRINCETON, N.J., Oct. 24, 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 United
States (US) Patent Office has allowed the divisional patent
application titled "Systems and Methods for Producing Synthetic
Hypericin". The allowed claims are directed to unique,
proprietary methods to produce a novel, highly purified form of
synthetic hypericin. Synthetic hypericin is the active
pharmaceutical ingredient in SGX301, the Company's photodynamic
therapy for the treatment of cutaneous T-cell lymphoma (CTCL),
currently the subject of an actively recruiting pivotal Phase 3
clinical trial where final topline results are expected in the
first quarter of 2020. This new divisional claim set expands
on the previous issued claims in the parent US patent (No.
10,053,413) protecting the composition of the purified synthetic
hypericin and is expected to expire in 2036. These patents
broaden the patent protection conferred by earlier issued US
patents covering methods of use (No. 7,122,518) and methods of
synthesis (No. 8,629,302).
SGX301 is a novel, first-in-class, photodynamic therapy that
combines synthetic hypericin, a potent photosensitizer that is
applied to the cancerous CTCL skin lesions and activated using a
brief, safe, fluorescent light treatment. This treatment
approach is expected to minimize 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 A and B
exposure.
Based on the positive results demonstrated in the Phase 2 study
of SGX301, the Phase 3 protocol is a highly powered, double-blind,
randomized, placebo-controlled, multicenter trial seeking to enroll
160 subjects. The Phase 3 study is referred to as the FLASH
(Fluorescent Light Activated Synthetic Hypericin) trial. 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 will receive SGX301 treatment and 53 will receive placebo
treatment of their index lesions. In the second cycle, all
subjects will receive SGX301 treatment of their index lesions and
in the third (optional) cycle all subjects will receive SGX301
treatment of all their lesions. Subjects will be
followed for an additional 6 months after the completion of
treatment. To date, the majority of patients enrolled have
elected to continue on with the optional, open-label component of
the study. An interim analysis completed in October 2018 identified a promising signal and
adjusted the study sample size to maintain the rigorous 90% power
of the study.
"This recently issued patent continues to expand, strengthen and
protect our synthetic hypericin patent estate," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "With the support of the National
Cancer Institute (NCI), most recently providing $1.5 million of funding under a two year Small
Business Innovative Research (SBIR) grant, as well as important
contributions from key patient advocacy organizations, such as the
Cutaneous Lymphoma Foundation, we look forward to completing the
ongoing Phase 3 CTCL study to potentially address the unmet medical
need that currently exists in this orphan disease. Final efficacy
results from this study are expected in 1Q 2020."
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 500,000 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 20,000 individuals in the US, with
approximately 2,800 new cases seen annually.
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.
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).
The Phase 3 CTCL clinical study is partially funded with this
NCI Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix,
Inc.
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 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 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®. Also, no assurance can be
provided that the Company will receive or continue to receive
non-dilutive government funding from grants and contracts that have
been or may be awarded or for which the Company will apply in the
future. 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.