Celsion Corporation Provides Clinical Update on Phase I/II OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer Including En...
February 25 2021 - 8:45AM
Celsion Corporation (NASDAQ:
CLSN), a clinical-stage development company focused on
DNA-based immunotherapy and next-generation vaccines, today
provided an update on its Phase I/II OVATION 2 Study with GEN-1 in
patients with advanced ovarian cancer, including interim
observations. GEN-1 is Celsion’s DNA-mediated interleukin-12
(IL-12) immunotherapy designed using TheraPlas, its proprietary,
synthetic, non-viral nanoparticle delivery system platform.
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).
To date, the Company has enrolled approximately
one-third, or 34 patients, of the anticipated 110 patients to be
enrolled into the OVATION 2 Study, of which 20 are in the treatment
arm and 14 are in the control. Currently, 27 patients have had
their interval debulking surgery with the following results:
- 12 of 15, or 80%, of patients
treated with GEN-1 had a R0 resection, which indicates a
microscopically margin-negative complete resection in which no
gross or microscopic tumor remains in the tumor bed.
- 7 of 12 patients, or 58%, of patients in the control arm had an
R0 resection.
- This interim data represents a 38%
improvement in R0 resection rates for GEN-1- patients compared with
control arm patients and is consistent with the reported
improvement in resection scores noted in the encouraging Phase I
OVATION I Study, the manuscript of which has been submitted for
peer review publication.
“As the goal for surgical debulking is to
eliminate microscopic disease, more ovarian cancer patients require
neoadjuvant chemotherapy. However, little progress has been made in
adding additional efficacious immunotherapy agents to standard
neoadjuvant chemotherapy,” said Premal H. Thaker, M.D., MSc.,
Professor in Gynecologic Oncology and Director of Gynecologic
Oncology Clinical Research at Washington University School of
Medicine in St. Louis and lead Principal Investigator for the
OVATION 2 Study. “The results seen to date in the OVATION 2 Study
are exciting and impactful for ovarian cancer patients.”
The Company further reports that 22 clinical
sites in the U.S. and Canada have been initiated, with three more
sites expected to be added by the end of the first quarter.
Clinical investigators met in early February in a virtual meeting
and expressed excitement about the potential for GEN-1 to treat
advanced ovarian cancer and, despite the challenges and earlier
delays posed by the COVID-19 pandemic, they remain committed to
completing enrollment in the study during the second half of
2021.
Commenting on the interim patient reports, Dr.
Nick Borys, chief medical officer of Celsion, said, “We are
gratified that such a high proportion of GEN-1 patients had no
residual disease at the time of their debulking surgery. These
results are consistent with what we observed in our Phase I
(OVATION I) study. This is great news for the patients and the
surgeons in our study as a R0 resection suggests a good clinical
outcome. We are following our patients carefully to see how well
they do long term. The OVATION 2 investigators remain enthusiastic
about the potential of GEN-1 to treat late-stage ovarian cancer,
which currently has few treatment options.”
Celsion announced earlier this week that GEN-1
had received Fast Track designation from the U.S. Food and Drug
Administration (FDA). This 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 clinically significant toxicity of an available
therapy that is common and causes discontinuation of treatment
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 1 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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