Celsion Announces FDA Clearance of the OVATION II Study for the Evaluation of GEN-1 Immunotherapy to Treat Newly Diagnosed...
January 04 2018 - 7:00AM
GEN-1 to Enter the Clinic in Mid-2018 Following a
Phase IB Trial Which Demonstrated 100% Disease Control, 86%
Objective Response Rate and 86% R0 & R1 Surgical Resection Rate
in All Patients Treated
Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced that the U.S. Food and Drug
Administration (FDA), following the customary 30 day review period,
has accepted its submission without comment, providing clearance
for the OVATION II Study, the Company’s planned Phase I/II clinical
trial of GEN-1, its DNA-based immunotherapy for the localized
treatment of ovarian cancer. The Phase I/II trial was
developed with extensive input from the Company’s Medical Advisory
Board. The OVATION II Study builds on the highly promising clinical
and translational research data from the Phase IB dose-escalating
OVATION Study where 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, in
combination with neoadjuvant chemotherapy, followed by interval
debulking surgery.
This next Phase I/II study is designed with a
single dose escalation phase to 100 mg/m² to identify a safe and
tolerable dose of GEN-1 while maximizing an immune response,
followed by a continuation at the selected dose in Phase II in an
open label, 1:1 randomized design up to 90 patients with Stage
III/IV ovarian cancer at up to fifteen U.S. centers. The
study is powered to show a 33% improvement in the primary endpoint,
progression-free survival (PFS), when comparing GEN-1 with
neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone.
Progression-free survival for patients treated
per protocol in the Phase IB OVATION Study continues to be
followed. Of the thirteen patients who received GEN-1
treatment in all four dose escalating cohorts, only four patients’
cancer has progressed to-date. 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. Summarized below are the latest PFS results for all
patients treated per protocol in the Phase IB OVATION
Study:
- Cohort 1 (36 mg/m²) – All patients have progressed; Average PFS
was 19.25 months; Longest progression-free patient in 1st cohort
was 24.8 months.
- Cohort 2 (47 mg/m²) – No patients have progressed after 21
months.
- Cohort 3 (61 mg/m²) – One patient has progressed after 14
months; Two other patients in 3rd cohort are progression free over
17 months.
- Cohort 4 (79 mg/m²) – No patients have progressed; Average PFS
for these five patients in 4th cohort is 14 months.
“In previous clinical studies performed to date,
GEN-1 has demonstrated excellent safety and impressive clinical
activity supported with dose dependent, pro-immune improvement in
the tumor micro environment. A onetime dose escalation may
prove to be even more impressive,” stated Dr. Nicholas Borys,
Celsion’s senior vice president and chief medical officer.
“As we continue to follow patients, the latest PFS analysis from
the OVATION Study is showing a median of at least 15.4 months in
the as-treated group which compares favorably to a historical
control of 12 months. Our highest dose cohort has not
demonstrated any progressions at our current 14 month follow
up. This same cohort also had a 100% R0 surgical resection
rate. One of our patients in the OVATION Study even had a
complete pathological response.”
The Company expects to initiate enrollment of
the Phase I portion of the OVATION II Study in the first half of
2018. The Company expects to have 25% of the study 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 for tremendous
promise as a cancer treatment in the rapidly emerging area of
immunotherapy. This new trial will evaluate GEN-1’s 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,” said Michael H. Tardugno, Celsion’s chairman, president
and chief executive officer. “Designed in consultation with leading
medical experts, 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 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
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