PRINCETON, N.J., April 6, 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 the European patent office has granted
the divisional patent application titled "Formulations and Methods
of Treatment of Skin Conditions" (No. 2932973). The granted
claims are directed to the therapeutic use of synthetic hypericin
in the treatment of cutaneous T-cell lymphoma (CTCL).
Synthetic hypericin is the active pharmaceutical ingredient in
SGX301, the Company's photodynamic therapy, for which positive
primary endpoint results in a pivotal Phase 3 study for the
treatment of CTCL were recently announced (available here).
This new patent expands on Soligenix's comprehensive patent estate,
which includes protection on the composition of the purified
synthetic hypericin, methods of synthesis and therapeutic methods
of use in both CTCL and psoriasis, and is being pursued
worldwide.
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.
In the double-blind, placebo-controlled Phase 3 "FLASH"
(Fluorescent Light Activated Synthetic Hypericin) trial, SGX301
demonstrated a statistically significant improvement (p=0.04) in
its primary endpoint after just 6 weeks of therapy (Cycle 1).
The open-label extended treatment (Cycles 2 and 3) and 6–month
safety follow-up remain ongoing, with data from Cycle 2 expected to
be available in June 2020. Preliminary assessment of the
blinded Cycle 2 results suggest a more robust response rate after
12 weeks of SGX301 treatment.
"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 non-dilutive 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 pivotal Phase 3 CTCL study to
potentially address the unmet medical need that currently exists in
this orphan disease.
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 Synthetic Hypericin
Synthetic hypericin, the active ingredient in SGX301, is 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. 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).
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 targeted to
enroll 160 evaluable subjects. 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 will be determined at the end of Week 8. In the
first treatment cycle, 116 subjects received SGX301 and 50 subjects
received placebo treatment of their index lesions. In the
second cycle, all subjects received SGX301 treatment of their index
lesions and in the third cycle all subjects could receive SGX301
treatment of all their lesions. Subjects are followed
for an additional 6 months after the completion of treatment.
The primary efficacy endpoint was assessed on the percent of
patients in each of the two treatment groups (i.e., SGX301 and
placebo) achieving a Partial or Complete Response (yes/no) of the
treated lesions defined as a ≥ 50% reduction in the total Composite
Assessment of Index Lesion Disease Severity (CAILS) score for three
index lesions at the Cycle 1 evaluation visit (Week 8) compared to
the total CAILS score at baseline. Assessment of the primary
endpoint revealed that 16% patients receiving SGX301 responded
(i.e., had ≥ 50% reduction in index lesion size) while only 4%
receiving placebo responded (p=0.04). Preliminary results
from blinded data to date suggest more than a 35% response rate
(inclusive of patients receiving both 12 weeks and 6 weeks of
therapy), indicating the response increases with continued
treatment.
Other secondary measures assessed are treatment response
(including duration), degree of improvement, time to relapse and
safety, and will be available as the subsequent cycles and
follow-up visits are completed for all
subjects.
Overall safety of SGX301 is a critical attribute of this
treatment and will continue to be monitored throughout the
additional treatment cycles and the 6-month follow-up period.
SGX301's mechanism of action is not associated with DNA damage,
making it a safer alternative than currently available therapies,
all of which are associated with significant and sometimes fatal,
side effects. Predominantly these include the risk of
melanoma and other malignancies, as well as the risk of significant
skin damage and premature skin aging. Currently available
treatments are only approved in the context of previous treatment
failure with other modalities and there is no approved front-line
therapy available. Within this landscape, treatment of CTCL
is strongly motivated by the safety risk of each product.
SGX301 potentially represents the safest available efficacious
treatment for CTCL. With no systemic absorption, a compound
that is not mutagenic and a light source that is not carcinogenic,
there is no evidence to date of any potential safety
issues.
The Phase 3 CTCL clinical study was partially funded by the
National Cancer Institute via a 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, SGX943, our therapeutic candidate for antibiotic
resistant and emerging infectious disease, and our research
programs to identify and develop novel vaccine candidates targeting
viral infection including Ebola, Marburg and SARS-CoV-2 (the cause
of COVID-19). 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 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 any of our other clinical/preclinical
trials. Despite the statistically significant result achieved
in the SGX301 Phase 3 clinical trial for the treatment of cutaneous
T-cell lymphoma, there can be no assurance that a marketing
authorization from the FDA or EMA will be successful.
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.
View original
content:http://www.prnewswire.com/news-releases/soligenix-receives-european-patent-for-therapeutic-use-of-synthetic-hypericin-to-treat-cutaneous-t-cell-lymphoma-301034615.html
SOURCE Soligenix, Inc.