CORRECTING and REPLACING -- Celsion Files Immunotherapy Clinical Protocol for the Evaluation of GEN-1 to Treat Newly Diagnose...
November 13 2017 - 7:23PM
Expert Advisory Board Endorses Randomized
Phase I/II Trial in Newly Diagnosed Stage III and IV Ovarian
Cancer
In a press release issued earlier today by Celsion Corporation
(NASDAQ:CLSN), please note multiple changes were made to the
fourth bullet point of the release. The corrected release
follows:
Celsion Corporation (NASDAQ:CLSN), an oncology
drug development company, today announced the submission of its
Phase I/II clinical trial protocol to the U.S. Food and Drug
Administration (FDA) for GEN-1, the Company’s DNA-based
immunotherapy for the localized treatment of ovarian cancer.
The protocol, developed in conjunction with guidance from the
Company’s Medical Advisory Board, is designed with a single dose
escalation to evaluate the safety and biological activity of GEN-1
at 100mg/m² in newly diagnosed Stage III/IV ovarian cancer
patients, followed by a continuation at the selected dose in Phase
II in a 90 patient 1 to 1 randomized study. GEN-1 has demonstrated
encouraging safety and efficacy data in a recently completed dose
escalating Phase IB trial in combination with neoadjuvant
chemotherapy, the standard of care for patients newly diagnosed
with ovarian cancer. Concurrently with neoadjuvant
chemotherapy, enrolled patients received escalating weekly doses of
GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and
79mg/m² weekly for 8 treatments in total, followed by interval
debulking surgery.
“GEN-1 is designed to locally activate IL-12
production which can recruit and stimulate the patient’s immune
system to attack and destroy cancer,” stated Dr. Nicolas Borys,
Celsion’s senior vice president and chief medical officer.
“In preclinical and multiple Phase I clinical studies performed to
date, GEN-1 has demonstrated good safety and impressive immune
system stimulation and clinical activity. This trial will
evaluate its value as an adjuvant to current standard of care in
newly diagnosed Stage III/IV ovarian cancer patients with a
relatively healthy immune system. We look forward to initiating the
study in the first half of 2018.”
The Phase I/II study builds on the highly
promising clinical and translational research data for the recently
completed Phase IB dose-escalating OVATION Study. This next
Phase I/II study will have a dose escalating phase to 100 mg/m² to
identify a safe and tolerable dose of GEN-1 while maximizing an
immune response. The study protocol was unanimously supported
by an expert medical advisory board and lead investigators from the
Phase IB OVATION Study and is summarized below:
- Open label, 1:1 randomized design
- Enrollment up to 90 patients with Stage III/IV ovarian cancer
patients at ten U.S. centers
- Primary endpoint of improvement in progression-free survival
(PFS) comparing GEN-1 with neoadjuvant chemotherapy versus
neoadjuvant chemotherapy alone.
- PFS for patients treated per protocol in the Phase IB OVATION
Study continues to be followed. Of the eight patients who
received GEN-1 treatment over one year ago (cohort 1 – 3) and are
being followed, only three patients’ cancer has
progressed. This compares favorably to the historical median
progression-free survival of 12 months for newly-diagnosed patients
with Stage III and IV ovarian cancer that undergo neoadjuvant
chemotherapy followed by interval debulking surgery. Of the
remaining five patients who have been on the OVATION Study for
over one year, their median PFS as of October 31, 2017
is 18.8 months with the longest progression-free patient
at 24 months.
The protocol has been submitted to the FDA for
its 30 day review and comment period. Pending this review,
the Company expects to initiate enrollment of the Phase I portion
of the study in the first half of 2018. The Company expects
to have the study 50% enrolled by the end of 2018. Due to the
open label design, clinical data will be disclosed throughout the
execution of the trial as it is released by the study’s
investigators.
“GEN-1 holds the potential of tremendous promise
as a cancer treatment in the rapidly emerging area of
immuno-oncology. Unlike the toxicities, poor tolerability, and poor
pharmacokinetics of systemically administered recombinant IL-12,
the beauty of GEN-1 is that it inspires secretion of
highly-tolerable endogenous IL-12,” said Michael H. Tardugno,
Celsion’s chairman, president and chief executive officer.
“Designed in consultation with leading thought leaders, this Phase
I/II trial is expected to define an optimal dose, demonstrate
GEN-1’s clinical benefit when compared with current standard of
care, and provide insights on powering for a registration program
as the candidate progresses through development.”
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
recently completed 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. 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 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 Aug 2024 to Sep 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Sep 2023 to Sep 2024