Celsion Corporation Receives FDA Fast Track Designation for GEN-1 in Advanced Ovarian Cancer
February 22 2021 - 7:30AM
Celsion Corporation (NASDAQ:
CLSN), a clinical stage development company focused on DNA
based immunotherapy and next generation vaccines, today announced
that it has received Fast Track designation from the U.S. Food and
Drug Administration (FDA) for GEN-1, its DNA-mediated
interleukin-12 (IL-12) immunotherapy currently in Phase II
development for the treatment of advanced ovarian cancer. GEN-1 was
designed using TheraPlas, Celsion's proprietary, synthetic,
non-viral nanoparticle delivery system platform.
Fast Track designation is intended to facilitate
the development and expedite the regulatory review of drugs to
treat serious conditions and fill an unmet medical need. According
to the FDA, a Fast Track Drug must show some advantage over
available therapy, including:
- Showing superior effectiveness, effect on serious outcomes or
improved effect on serious outcomes
- Avoiding serious side effects of an available therapy
- Decreasing a clinical significant toxicity of an available
therapy that is common and causes discontinuation of treatment
“Fast Track designation is an important step in
developing GEN-1 for advanced ovarian cancer. Presuming the
encouraging data we are generating in early clinical studies
continues, this designation supports an expedited path to market,”
said Michael H. Tardugno, Celsion’s chairman, president and chief
executive officer. “Fast Track allows for more frequent
communication with the FDA to discuss development plans and
clinical trial design. In addition, should criteria be met, Fast
Track-designated drugs are eligible for rolling review, a process
whereby the drug’s sponsor can separately submit sections of its
New Drug Application to the FDA. They also are eligible for
accelerated approval and priority review, under which drugs for
serious conditions fulfilling an unmet medical need can be approved
based on a surrogate endpoint. We are optimistic that GEN-1
represents a game-changer for women with advanced ovarian cancer
who have limited treatment options.”
GEN-1 is the subject of Celsion’s Phase II
OVATION 2 Study, which combines GEN-1 with standard-of-care
neoadjuvant chemotherapy (NACT) in patients newly diagnosed with
Stage III/IV ovarian cancer. NACT is designed to shrink the cancer
as much as possible for optimal surgical removal after three cycles
of chemotherapy. Following NACT, patients undergo interval
debulking surgery, followed by three adjuvant cycles of
chemotherapy and up to nine additional weekly GEN-1 treatments, the
goal of which is to delay progression and improve overall survival.
The OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80%
powered to show the equivalent of a 33% improvement in
progression-free survival (PFS) (HR=0.75), the primary endpoint,
when comparing the treatment arm (standard of care + GEN-1) with
the control arm (standard of care alone).
As Celsion has previously announced, it has
shared with the FDA data from the Phase I portion of the Phase I/II
OVATION 2 Study that showed successful tumor resections, with seven
out of eight patients (88%) in the GEN-1 treatment arm having a
complete tumor resection (R0), which indicates a microscopically
margin-negative resection in which no gross or microscopic tumor
remains in the tumor bed. The NACT-only treatment arm had an R0
resection rate of 50%.
Patients in the Company’s completed Phase 1b
dose-escalation OVATION I Study showed compelling objective
response rates, with 100% of patients in high-dose cohorts
experiencing a complete or partial response, and 67% of patients in
lower-dose cohorts experiencing a complete or partial response.
Further, R0 resections in the high-dose cohorts was 88%, compared
with 33% in the low-dose cohorts.
In addition, Celsion compared matched patient
data in a synthetic control arm with results from the OVATION I
Study. Patients in the GEN-1 arm virtually demonstrated a doubling
of control of their cancer compared with the synthetic control arm.
Findings are not statistically significant due to the small number
of patients. This comparison showed positive data in
progression-free survival (PFS) as follows:
GEN-1 Population |
PFS Hazard Ratio (Confidence Interval) |
Intent-to-treat, n=15 |
0.53 (95% CI 0.16, 1.73); log-rank p=0.29 |
Per-protocol, n=14 |
0.33 (95% CI 0.08, 1.37); log-rank p=0.11 |
About GEN-1 Immunotherapy
GEN-1, designed using Celsion's proprietary
TheraPlas platform technology, is an IL-12 DNA plasmid vector
encased in a nanoparticle delivery system, which enables cell
transfection followed by persistent, local secretion of the IL-12
protein. IL-12 is one of the most active cytokines for the
induction of potent anti-cancer immunity acting through the
induction of T-lymphocyte and natural killer (NK) cell
proliferation. The Company has previously reported positive safety
and encouraging Phase I results with GEN-1 given as monotherapy or
a combination therapy in patients with advanced peritoneally
metastasized primary or recurrent ovarian cancer, and recently
completed a Phase Ib dose-escalation trial (OVATION I Study) of
GEN-1 in combination with carboplatin and paclitaxel in patients
with newly diagnosed ovarian cancer.
About Celsion
Corporation
Celsion is a fully integrated, clinical stage
biotechnology company focused on advancing a portfolio of
innovative cancer treatments, including immunotherapies and
DNA-based therapies; and a platform for the development of nucleic
acid vaccines currently focused on SARS-CoV2. The company’s product
pipeline includes GEN-1, a DNA-based immunotherapy for the
localized treatment of ovarian cancer. ThermoDox®, a proprietary
heat-activated liposomal encapsulation of doxorubicin, is under
investigator-sponsored development for several cancer indications.
Celsion also has two feasibility stage platform technologies for
the development of novel nucleic acid-based immunotherapies and
other anti-cancer DNA or RNA therapies. Both are novel synthetic,
non-viral vectors with demonstrated capability in nucleic acid
cellular transfection. For more information on Celsion, visit
www.celsion.com.
Forward-looking Statements
Forward-looking statements in this news release
are made pursuant to the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. These statements are
subject to a number of risks and uncertainties, many of which are
difficult to predict, including, unforeseen changes in the course
of research and development activities and in clinical trials; the
uncertainties of and difficulties in analyzing interim clinical
data, particularly in small subgroups that are not statistically
significant; FDA and regulatory uncertainties and risks; the
significant expense, time and risk of failure of conducting
clinical trials; the need for Celsion to evaluate its future
development plans; possible acquisitions or licenses of other
technologies, assets or businesses; possible actions by customers,
suppliers, competitors or regulatory authorities; and other risks
detailed from time to time in the Celsion's periodic filings with
the Securities and Exchange Commission. Celsion assumes no
obligation to update or supplement forward-looking statements that
become untrue because of subsequent events, new information or
otherwise.
Celsion Investor ContactJeffrey
W. ChurchExecutive Vice President and
CFO609-482-2455jchurch@celsion.com
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
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