Celsion Corporation Initiates Phase II OVATION 2 Study of GEN-1 in Advanced Ovarian Cancer
July 27 2020 - 8:30AM
Celsion Corporation (NASDAQ: CLSN), an oncology
focused drug-development company, today announced the randomization
of the first two patients in the Phase II portion of the Phase I/II
OVATION 2 Study with GEN-1 in advanced ovarian cancer. The Company
anticipates completing enrollment of up to 118 patients in the
third quarter of 2021. Because this is an open-label study, the
Company intends to provide clinical updates throughout the course
of treatment including response rates and surgical resection
scores.
GEN-1 was designed using TheraPlas, Celsion's
proprietary, synthetic, non-viral nanoparticle delivery system
platform. It is an interleukin-12 (IL-12) DNA plasmid vector
associated with a non-viral nanoparticle delivery system, which
enables cell transfection followed by persistent, local secretion
of the IL-12 protein.
The OVATION 2 Study 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).
“During the first half of 2020, we reported data
from the Phase I portion of the OVATION 2 Study that showed
successful tumor resections, with seven out of eight patients
(87.5%) 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%,” said Dr. Nicolas Borys, Celsion’s Chief Medical Officer. “The
Company engaged Medidata/Acorn to independently evaluate our data
using a propensity matched synthetic control arm (SCA) with results
from the Company’s previously completed Phase I studies. The
results suggested that GEN-1 nearly doubled progression-free
survival (PFS) in these patients. These findings are not
statistically significant, however, due to the small number of
patients, but nonetheless are encouraging and supportive of our
current Phase II study.”
“This past May we reported that the Data Safety
Monitoring Board recommended that the Phase II portion of the
OVATION 2 Study proceed with a GEN-1 dose of 100 mg/m²,” said
Michael H. Tardugno, Chairman, President and Chief Executive
Officer of Celsion. “Patients will undergo up to 6 months of
immunostimulatory GEN-1 treatment. Based on results from earlier
studies, we believe this regimen holds great potential to alter the
current treatment paradigm, and in doing so improve survival for
ovarian cancer patients, whose prognosis is generally poor. Our
investigators are among the leading researchers in ovarian cancer.
Together, we are delighted to have begun enrolling patients in the
Study and look to achieve our goal of providing new novel
therapeutic options to patients with this difficult-to-treat
cancer.”
In March 2020 the Company announced the European
Medicines Agency Committee for Orphan Medicinal Products
recommended that GEN-1 be designated as an orphan medicinal product
for the treatment of ovarian cancer. GEN-1 previously received
orphan designation from the U.S. Food and Drug Administration for
the treatment of ovarian cancer. This designation by the EMA
provides 10 years of exclusivity once approved for marketing.
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 trial of GEN-1 in combination with PEGylated
doxorubicin in patients with platinum-resistant ovarian cancer.
About Celsion
Corporation
Celsion is a fully integrated oncology company
focused on developing a portfolio of innovative cancer treatments,
including directed chemotherapies, immunotherapies and RNA- or
DNA-based therapies. The Company’s lead program is ThermoDox®, a
proprietary heat-activated liposomal encapsulation of doxorubicin,
currently in Phase III development for the treatment of primary
liver cancer and in development for other cancer indications. The
Company’s second product in its pipeline is GEN-1, a DNA-based
immunotherapy for the localized treatment of late stage ovarian
cancer. Celsion has two platform technologies for the development
of novel nucleic acid-based immunotherapies and other anti-cancer
DNA or RNA therapies.
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. Readers are cautioned
that such forward-looking statements involve risks and
uncertainties including, without limitation, 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 CFO609-482-2455
jchurch@celsion.com
Or
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
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