Celsion Announces Ovarian Cancer Expert Presentation at Oppenheimer & Co. Investor Event
March 05 2018 - 10:15AM
Celsion Corporation (NASDAQ: CLSN) today announced that Premal H.
Thaker, M.D., M.S., Associate Professor of Obstetrics and
Gynecology at the Siteman Cancer Center at the Washington
University School of Medicine in St. Louis, Mo. and investigator in
Celsion’s GEN-1 development program presented, “Ovarian Cancer: New
Horizons and Treatments” at an investor event hosted by Oppenheimer
& Co. in New York City on March 1, 2018. A nationally
recognized expert in gynecologic oncology, Dr. Thaker provided an
overview of the symptoms and diagnosis of ovarian cancer, current
standard of care and novel new therapies, including Celsion’s GEN-1
DNA-based, IL-12 immunotherapy currently in Phase I development for
the treatment of ovarian cancer.
“Ovarian cancer is the fourth deadliest cancer
among women in developed countries and often goes undetected in its
earlier stages, with more than 60% of patients first diagnosed at
Stage III/IV,” said Dr. Thaker. “Adequate surgery is vital in
treating ovarian cancer, with a complete resection (R0) being the
primary objective. Neoadjuvant chemotherapy is currently used to
reduce tumor burden and improve surgical outcomes, but new
treatment approaches in development, including anti-angiogeneic
inhibitors, PARP inhibitors and immunotherapies represent
compelling new areas of innovation that have the potential to
meaningfully improve outcomes. In this environment we have been
evaluating GEN-1’s potential to improve patient outcomes.”
“Ovarian cancer is characterized by a strong
immunosuppressive environment, and a spontaneous anti-tumor
reactive T-cells and antibodies,” Dr. Thaker continued. “Celsion’s
GEN-1 is a novel new approach that is designed to deploy the
anti-cancer mechanism of the potent, broad spectrum immunotherapy,
IL-12, without the toxicities associated with the recombinant IL-12
protein. In a Phase I study of GEN-1, 14 newly diagnosed patients
with Stage III/IV ovarian cancer were intraperitoneally
administered GEN-1 plus neoadjuvant chemotherapy. Results from the
study demonstrated immunological changes consistent with the
ability of GEN-1 to increase local (peritoneal) levels of IL-12 and
its downstream anti-cancer cytokines and reduction in vascular
endothelial growth factor (VEGF; potent angiogenic factor that
contributes to tumor angiogenesis) levels with little changes in
systemic circulation. Furthermore, the study showed no serious
systemic toxicities. These clinical findings, including a partial
or complete response in 86% of patients, R0 resections in 100% of
patients treated at the highest dose cohort and recently reported
progression-free survival (PFS) of 21 months compared to historical
controls for PFS of approximately 12 months, support further
evaluation of GEN-1’s safety and efficacy in patients with Stage
III/IV ovarian cancer.”
Celsion expects to initiate enrollment in the
Phase I portion of the OVATION II Study of GEN-1 during the first
half of 2018 in up to 90 patients with Stage III/IV ovarian cancer
at up to fifteen U.S. centers. The Phase I/II study will be powered
to show a 33% improvement in the primary endpoint, PFS, when
comparing GEN-1 with neoadjuvant chemotherapy to neoadjuvant
chemotherapy alone.
Slide Presentation Available on
Celsion’s Website
To view Dr. Thaker’s full slide presentation
from the event, please visit Celsion’s corporate website at
http://investor.celsion.com/scientific-presentations .
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 in
patients with peritoneally metastasized ovarian cancer, and 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 Phase II development for the treatment of
recurrent chest wall breast cancer. The pipeline also
includes GEN-1, a DNA-based immunotherapy for the localized
treatment of ovarian and brain cancers. Celsion has two
platform technologies for the development of novel nucleic
acid-based immunotherapies and other anti-cancer DNA or RNA
therapies. For more information on Celsion, visit our
website: http://www.celsion.com. (CLSN-G1 CLSN-OV)
Celsion wishes to inform readers that
forward-looking statements in this 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, regulatory authorities; and other risks
detailed from time to time in the Celsion's periodic reports and
prospectuses filed 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 Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Apr 2023 to Apr 2024