PRINCETON, N.J., April 30, 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 continued treatment with SGX301
(synthetic hypericin) twice weekly for 12 weeks increased the
positive response rate to 40% (p<0.0001 compared to placebo and
p<0.0001 compared to 6-weeks treatment) in the open-label
treatment cycle (referred to as Cycle 2) of its pivotal Phase 3
FLASH (Fluorescent Light Activated Synthetic Hypericin) study for
the treatment of early-stage cutaneous T-cell lymphoma
(CTCL). These highly statistically significant results
confirm the benefit of continued SGX301 treatment in CTCL
patients.
Soligenix previously announced positive top-line results when
the study achieved statistical significance (p=0.04) in its primary
endpoint over the first 6 week double-blind treatment cycle
(referred to as Cycle 1) (available here). The study enrolled
169 patients randomized 2:1 to receive either SGX301 or placebo in
Cycle 1. After the subsequent additional 6-week treatment in
the open-label Cycle 2, the response rate in patients receiving a
total of 12 weeks treatment increased two and a half-fold.
Treatment responses for each cycle were assessed at Week 8 (after 6
weeks of treatment) and at Week 16 (after 12 weeks of
treatment). A positive response was defined as an improvement
of at least 50% in the Composite Assessment of Index Lesion Score
(CAILS) for three index lesions evaluated in both Cycles 1 and
2. The data continues to indicate that SGX301 is safe and well
tolerated.
"As anticipated, the data continues to become more compelling
with extended SGX301 treatment," stated Ellen Kim, MD, Director of the Dermatology
Clinic, Perelman Center for Advanced Medicine and Lead Investigator
of the FLASH study. "This treatment response is comparable to
other, less safe, treatment alternatives, showing a statistically
significant response at just 6 weeks, which continues to
significantly increase with more treatment. The response rate
at 12 weeks is similar to other therapies, some of which patients
must take for more than a year. In addition to the efficacy
demonstrated, SGX301 remains well tolerated with a unique mechanism
of action that is not associated with DNA damage like other
currently available therapies. I look forward to working with
Soligenix to move this important new therapy forward with US Food
and Drug Administration (FDA) so that patients may access it as
soon as possible."
"The availability of a safe, rapid-acting, treatment for CTCL is
extremely important to patients," stated Ms. Susan Thornton, Chief Executive Officer of the
Cutaneous Lymphoma Foundation, the largest patient advocacy
organization for CTCL. "From the patient perspective, you
want a treatment that is safe and effective with the least amount
of side effects. Many of the therapies available today either
don't work for all patients, don't work for long-periods of time,
can't be used by some because of their concerning side effects, or
are used off-label creating access issues. As the leader of
the patient organization and a patient myself, I know first-hand
the importance of developing more therapies and options to support
people living with this rare cancer."
"On behalf of everyone at Soligenix, I would like to again
extend my sincere appreciation to the patients, families,
investigators, and advisors involved in the pivotal Phase 3 FLASH
study," stated Christopher J.
Schaber, PhD, President and Chief Executive Officer of
Soligenix. "We are extremely pleased with the study results, which
demonstrate successful continued treatment with SGX301 and
reinforces its potential to be a valuable and life-changing new
therapy for patients suffering from early-stage CTCL, which is an
orphan disease and area of unmet medical need."
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 patches and may
progress to raised plaques and tumors. 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 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 drugs and other phototherapy 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 FDA, as well as orphan designation
from the European Medicines Agency (EMA).
The Phase 3 FLASH trial enrolled a total of 169 patients (166
evaluable) with Stage IA, IB or IIA CTCL. The trial consists of
three treatment cycles. Treatments were administered twice weekly
for the first 6 weeks and treatment response was determined at the
end of the 8th week of each cycle. In the first double-blind
treatment cycle, 116 subjects received SGX301 treatment (0.25%
synthetic hypericin) and 50 received placebo treatment of their
index lesions. A total of 16% of the patients receiving SGX301
achieved at least a 50% reduction in their lesions (graded using a
standard measurement of dermatologic lesions, the CAILS score)
compared to only 4% of patients in the placebo group at 8 weeks
(p=0.04) during the first treatment cycle (primary endpoint).
SGX301 treatment in the first cycle was safe and well
tolerated.
In the second open-label treatment cycle (Cycle 2), all patients
received SGX301 treatment of their index lesions. Evaluation of 155
patients in this cycle (110 receiving 12 weeks of SGX301 treatment
and 45 receiving 6 weeks of placebo treatment followed by 6 weeks
of SGX301 treatment), demonstrated that the response rate among the
12-week treatment group was 40% (p<0.0001 vs the placebo
treatment rate in Cycle 1). Comparison of the 12-week and 6-week
treatment groups also revealed a statistically significant
improvement (p<0.0001) between the two groups, indicating that
continued treatment results in better outcomes. SGX301
continued to be safe and well tolerated.
In the third (optional) treatment cycle (Cycle 3), all subjects
could receive SGX301 treatment of all their lesions. Of note, the
majority of patients enrolled have elected to continue with this
optional cycle of the study. Moreover, in a subset of patients
evaluated in this cycle, it was demonstrated that SGX301 is not
systemically available, consistent with the general safety of this
topical product observed to date. Other secondary measures assessed
are treatment response (including duration), degree of improvement,
and time to relapse and safety. Results from Cycle 3 and the
subsequent 6-month follow-up after completion of treatment will be
further announced as the final patients continue to complete their
designated visits.
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, such as
experienced with the COVID-19 outbreak. 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.
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