PRINCETON, N.J., Dec. 3, 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 it has completed patient enrollment in its
Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH)
study for SGX301 (synthetic hypericin) in the treatment of
cutaneous T-cell lymphoma (CTCL). The study successfully
enrolled 169 subjects, following positive interim analysis, which
included a prospectively defined, unblinded assessment of the
study's primary efficacy endpoint by an independent Data Monitoring
Committee (DMC). With enrollment completed, top-line results
are expected in the first quarter of 2020.
SGX301 is a novel, first-in-class, photodynamic therapy that
combines synthetic hypericin, a potent photosensitizer that is
applied as an ointment to the cancerous 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 exposure to ultraviolet A and B
light.
"We are pleased to have completed enrollment and look forward to
the top-line results in the first quarter of next year,
particularly in light of the DMC recommendation at the interim
analysis which observed a beneficial drug effect," stated
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix. "We have
invested a significant amount of the Company's resources into the
CTCL development program and continue to positively position this
fast-tracked program for approval. We believe SGX301 has the
potential to be a valuable therapy in the front-line treatment of
early stage CTCL, which is an orphan disease and area of unmet
medical need."
"SGX301 has the potential to have a significant impact on the
lives of CTCL patients while minimizing their exposure to potential
secondary cancers," stated Richard
Straube, MD, Senior Vice President and Chief Medical Officer
of Soligenix. "We would like to thank the DMC members, our
esteemed medical advisory board and our dedicated clinical
investigators for their ongoing efforts in the design and conduct
of this important clinical trial, as well as all the subjects that
are participating in the trial. Our focus is now to complete
the treatments for all subjects and to lock the study database,
facilitating top-line results in the first quarter of
2020."
Based on the positive results demonstrated in the Phase 2 study
of SGX301, the Phase 3 trial is a highly powered, double-blind,
randomized, placebo-controlled, multicenter trial. The
primary efficacy endpoint is assessed as the percent of patients in
each of the two treatment groups (i.e., SGX301 and placebo)
achieving a successful response of the treated lesions at the end
of Cycle 1 (Week 8) compared to baseline. A successful treatment
response is defined as a 50% or greater reduction of the three
index lesions treated as determined by the cumulative Composite
Assessment of Index Lesion Severity (CAILS) scoring system.
Other secondary measures, including treatment response
(including duration), degree of improvement, time to relapse and
safety, are further determined by data collected throughout the
follow-on open-label portions of the trial in Cycle 2 (index
lesions treated in all patients) and Cycle 3 (all lesions treated
in all patients), as well as the six-month follow-up
period.
A prospectively defined interim analysis was conducted in
October 2018 by an independent DMC
and was used to verify the underlying assumptions defining the
required sample size of the study to maintain its rigorous 90%
statistical power. The DMC identified a beneficial SGX301
effect and accordingly adjusted the study sample size to
approximately 160. The DMC did not identify any safety concerns.
The interim recommendation is described in the October 2018 press release 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.
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 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 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 is partially funded with this
NCI Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix,
Inc.
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 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.