Celsion Corporation Announces DSMB has Confirmed Initial Safety of Weekly GEN-1 Dosing at 100 mg/m² in 15 Randomized Patien...
February 06 2020 - 9:25AM
Celsion Corporation (NASDAQ: CLSN) today announced that the
independent Data Safety Monitoring Board (DSMB) has completed its
initial safety review of data from the first fifteen patients
treated with the first four neoadjuvant doses of GEN-1 at 100 mg/m²
in the ongoing Phase I/II OVATION 2 Study. As requested by the U.S.
Food and Drug Administration (FDA), a follow-on Phase 1 review by
the DSMB will evaluate the safety of GEN-1 in up to 17 weekly doses
before initiating the Phase 2 portion of the Study. The OVATION 2
Study combines GEN-1, the Company's IL-12 gene-mediated
immunotherapy, with neoadjuvant chemotherapy (NACT), a standard of
care for newly diagnosed patients with Stage III and IV ovarian
cancer. Following NACT, patients undergo interval debulking surgery
(IDS) followed by three additional cycles of chemotherapy.
The OVATION 2 Study is an open label, 130
patient, 1 to 1 randomized Phase II trial, 80% powered to show the
equivalent of a 33% improvement in progression-free survival (PFS),
the primary endpoint, when comparing the treatment arm (NACT +
GEN-1) with the control arm (NACT alone). GEN-1, is a formulation
of Celsion's proprietary, synthetic, non-viral cell transfection
platform TheraPlas, incorporating, DNA plasmids coded for the
inflammatory protein, interleukin-12 (IL-12). Cell transfection is
followed by persistent, local secretion of the IL-12 protein,
expected at therapeutic levels.
The OVATION 2 Study builds on promising clinical
and translational research data from the Phase IB OVATION I Study,
in which enrolled patients received escalating weekly doses of
GEN-1 (from 36 mg/m² to 79 mg/m²) for a total of eight treatments
in combination with NACT, followed by IDS. These data from the
OVATION I Study were presented at the ASCO-SITC Clinical-Oncology
Symposium by Dr. Premal H. Thaker, M.D., M.S. on May 4, 2019 and
can be reviewed here. In addition to exploring a higher dose of
GEN-1 in the OVATION 2 Study, patients will continue to receive
GEN-1 after their IDS in combination with adjuvant
chemotherapy.
"This latest DSMB review of GEN-1 at 100 mg/m²
confirmed that there were no dose limiting toxicities detected in
any of the six evaluable patients (those patients who received at
least four doses of GEN-1) and that intraperitoneal GEN-1
administration is well tolerated even when given with standard
NACT," said Nicholas Borys, M.D., executive vice president and
chief medical officer of Celsion. “Of the fifteen patients treated
in the Phase I portion of the OVATION 2 Study, nine patients were
treated with GEN-1 plus NACT and six patients were treated with
NACT only. After the final six patients in the Phase I portion of
the Study have completed their interval debulking surgery, we will
be reporting surgical results and overall tumor response rates for
all fifteen patients from the Phase I portion of the trial later
this quarter.”
Dr. Borys concluded, “We anticipate that the
Phase II portion of the OVATION 2 Study will begin enrolling
patients at more than 25 clinical sites in the U.S. and Canada
beginning in the second quarter of 2020. As requested by the FDA, a
follow-on safety review will be conducted by the DSMB after all the
patients have concluded their chemotherapy dosing. The Study
protocol allows for up to 17 doses of GEN-1. Our goal is to
complete enrollment of all patients in the OVATION 2 Study by the
first quarter of 2021."
The OVATION 2 Study is supported with promising
clinical and translational data from the Company’s prior Phase Ib
OVATION I Study. In addition to a 100% objective response rate
(complete response + partial response) observed in all 9 patients
at the two highest dose cohorts, translational research data
demonstrates that GEN-1 is biologically active, producing
therapeutic levels of IL-12 cytokines and positively impacting
T-cell population in the tumor.
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. The pipeline also includes GEN-1, a DNA-based
immunotherapy for the localized treatment of ovarian cancer.
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; 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 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
LHA Investor Relations
Jeffrey W. Church
Kim Sutton
GolodetzExecutive Vice President, CFO and Corporate
Secretary609-482-2455
212-838-3777
jchurch@celsion.com
kgolodetz@lhai.com
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