Celsion Corporation (NASDAQ:
CLSN), a clinical-stage development company focused on
DNA-based immunotherapy and next-generation vaccines, today
announced that a poster on the Company’s Phase I/II OVATION 2 Study
with GEN-1 in advanced ovarian cancer has been accepted for
presentation at the Virtual Annual Meeting on Women’s Cancer,
sponsored by the Society of Gynecologic Oncology.
The conference is being held March 19-25, 2021.
The OVATION 2 Study design is being presented as a poster entitled
“A Phase I/II Study Evaluating Intraperitoneal GEN-1 in Combination
with Neoadjuvant Chemotherapy in Patients with Newly Diagnosed
Advanced Epithelial Ovarian Cancer (EOC)” in the “Trials in
Progress” poster session from March 19 to 25 (8 pm to 11 pm each
day). GEN-1 is Celsion’s DNA-mediated interleukin-12 (IL-12)
immunotherapy designed using TheraPlas, its proprietary, synthetic,
non-viral nanoparticle delivery system platform. Poster authors
are: P.H. Thaker, R.W. Holloway, L. Kuroki, S. E. DePasquale, W.H.
Bradley, A. ElNaggar, M.C. Bell, R.P. Rocconi, A. Bregar, M.D.
Indermaur, C. Gunderson, B. Pothuri, R. Agajanian, D. Warshal, D.
Provencher, M. McHale, V. John, M. Bergman, S. Lau, L. Musso, K.
Anwer, N. Borys, C.A. Leath III and the poster will be available
for virtual viewing during the meeting.
“We are delighted that the Society of
Gynecologic Oncology has accepted this poster for presentation,”
said Michael H. Tardugno, Celsion’s chairman, president and chief
executive officer. “The poster authors, led by the Study Chair of
the OVATION 2 Study Dr. Premal Thaker of Washington University
School of Medicine in St. Louis, are a Who’s Who of key opinion
leaders in women’s health. Celsion is grateful to have such
luminaries represent our study to their peers.”
The poster describes the 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).
The poster will be available
https://investor.celsion.com/scientific-presentations on March 19,
2021.
The Company recently announced that to date it
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, 28 patients have had their interval debulking surgery
with the following results:
- 13 of 16, or 81%, 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 40% 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 1 Study, the manuscript of which
has been submitted for peer review publication.
Celsion also announced last 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.
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 the Virtual Annual Meeting on
Women’s Cancer
The Society of Gynecologic Oncology (SGO) 2021
Annual Meeting on Women’s Cancer will be a fully virtual meeting,
allowing participants to access high-quality content and engage
remotely from around the world in a platform that will be designed
explicitly for this meeting. SGO is working hard to provide a great
virtual experience with the latest gynecologic cancer research and
education you have come to expect at the Annual Meeting on Women’s
Cancer. All education sessions will be recorded and available
through the virtual platform for attendees who register for the
meeting by March 25, 2021.
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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