Celsion Announces Presentation of GEN-1 Data at Upcoming ASCO-SITC Clinical Immuno-Oncology Symposium
January 15 2019 - 8:30AM
Data to be Highlighted During Oral Session on
March 2, 2019
Celsion Corporation (NASDAQ: CLSN), an oncology drug development
company, today announced that data from a Phase I study of GEN-1,
its DNA-based immunotherapy for the localized treatment of ovarian
cancer as an adjuvant to chemotherapy current standard of care, has
been selected for oral presentation at the upcoming ASCO-SITC
Clinical Immuno-Oncology Symposium held in San Francisco on Feb. 28
through March 2, 2019. The abstract titled, “Phase I study of the
safety and activity of formulated IL-12 plasmid administered
intraperitoneally in combination with neoadjuvant chemotherapy in
patients with newly diagnosed advanced stage ovarian cancer,” was
featured as a “Highlights” Abstract by ASCO-SITC and will be
presented by Premal H. Thaker, M.D., M.S., 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.
The abstract (Abstract 2) will be presented as
part of Oral Abstract Session C held on Saturday, March 2, 2019
from 10:15 – 11:30 a.m. PST (1:15 – 2:30 p.m. EST) at the San
Francisco Marriott Marquis.
About GEN-1
GEN-1, designed using Celsion's proprietary
TheraPlas platform technology, is an IL-12 DNA plasmid vector
encased in a synthetic, non-viral, 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 recurrent advanced ovarian
cancer. The Phase IB OVATION I Study, which evaluated escalating
doses of GEN-1 in combination with three cycles of neoadjuvant
chemotherapy prior to interval surgery followed by three cycles of
NAC in the treatment of newly diagnosed patients with Stage III/IV
ovarian cancer, demonstrated median progression-free survival (PFS)
of 24.3 months in patients treated per protocol (n=13) and 17.1
months for the intent-to-treat population (n=18) for all dose
cohorts, including three patients who dropped out of the study
after 13 days or less, and two patients who did not receive full
neoadjuvant chemotherapy (NAC) and GEN-1 cycles.
The OVATION 2 Phase I/II study in patients newly
diagnosed with Stage III/IV ovarian cancer, was initiated in
September 2018 and is designed with a single dose-escalation phase
to 100 mg/m² of GEN-1 administered intraperitoneally in the Phase I
portion, followed by a continuation at the selected dose in Phase
II, in an open-label, 1:1 randomized design. The OVATION 2 Study
will evaluate the effect of initial and maintenance dosing of GEN-1
on PFS in up to 130 patients.
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.
ThermoDox® is a registered trademark of Celsion Corporation.
Investor ContactArgot PartnersSam
Martin212-600-1902Sam@argotpartners.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