Celsion Announces Presentation of OVATION Study Findings at the Upcoming AACR Special Conference
24 August 2017 - 11:30PM
Celsion Corporation (NASDAQ:CLSN), an oncology drug development
company, today provided an update on its OVATION Study, a Phase Ib
dose escalating clinical trial combining GEN-1, the Company's
DNA-based immunotherapy, with the standard of care for the
treatment of newly-diagnosed patients with advanced (stage III/IV)
ovarian cancer who will undergo neoadjuvant chemotherapy followed
by interval debulking surgery. GEN-1 is an IL-12 DNA plasmid
vector formulated as a nanoparticle in a non-viral delivery system
to cause the sustained local production and secretion of the
Interleukin-12 (IL-12) protein loco-regionally to the tumor
site.
The Company announced that an abstract for the
OVATION Study has been accepted for presentation at the American
Association for Cancer Research (AACR) Addressing Critical
Questions in Ovarian Cancer Research and Treatment Special
Conference, which will take place from October 1 – 4, 2017 at the
Wyndham Grand Pittsburgh Downtown in Pittsburgh, PA.
- The abstract, entitled "Immunological changes following
intraperitoneal administration of a formulated IL-12 plasmid in
combination with neoadjuvant chemotherapy in newly diagnosed
advanced ovarian cancer patients," will be presented in a poster
presentation session by Dr. Khursheed Anwer, Celsion’s executive
vice president and chief scientific officer.
- The presentation will summarize clinical findings and
translational data from all patients treated in the Phase Ib dose
escalating clinical trial. The translational data provides
further insight into GEN-1's mechanism of action through the
evaluation of dose-related changes in the tumor and peritoneal
immune cell population, as well as through the peritoneal cytokine
levels.
Celsion previously reported highly encouraging
clinical data from the first fourteen patients who have completed
treatment in the OVATION Study. GEN-1 plus standard
chemotherapy produced positive clinical results, with no dose
limiting toxicities and promising dose dependent efficacy signals
which correlate well with successful surgical outcomes as
summarized below:
- Of the fourteen patients treated to date in the entire study,
two (2) patients demonstrated a complete response, ten (10)
patients demonstrated a partial response and two (2) patients
demonstrated stable disease, as measured by RECIST criteria. This
translates to a 100% disease control rate ("DCR") and an 86%
objective response rate ("ORR"). Of the five patients treated
in the highest dose cohort, there was a 100% objective response
rate with one (1) complete response and four (4) partial
responses.
- Fourteen patients had successful resections of their tumors,
with nine (9) patients (64%) having an R0 resection, which
indicates a microscopically margin-negative resection in which no
gross or microscopic tumor remains in the tumor bed.
Seven out of eight (87%) patients in the highest two dose cohorts
experienced a R0 surgical resection. All five patients treated at
the highest dose cohort experienced a R0 surgical resection.
- All patients experienced a clinically significant decrease in
their CA-125 protein levels as of their most recent study visit.
CA-125 is used to monitor certain cancers during and after
treatment. CA-125 is present in greater concentrations in ovarian
cancer cells than in other cells.
- Of the eight patients who have received GEN-1 treatment
over one year ago and are being followed, only two patients'
cancer has progressed. This compares favorably to the
historical median progression free survival (PFS) 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 six patients who have been on the
study for over one year, their average PFS as of this date is
17 months with the longest progression-free patient at
23 months.
"We have completed enrollment of our OVATION
Study in newly diagnosed ovarian cancer patients, one goal of which
is to determine GEN-1’s activity in combination with standard
chemotherapy. The remarkable surgical outcomes among all
patients completing the prescribed eight weekly treatments
reinforce our confidence in the promise of GEN-1’s ability to work
safely and effectively in advanced ovarian cancer," said Michael H.
Tardugno, Celsion's chairman, president and CEO. “We have scheduled
an Advisory Board Meeting in late September 2017 with our clinical
investigators and scientific experts from the Roswell Park Cancer
Institute and M.D. Anderson Cancer Center to review the clinical
and translational research data from the OVATION Study in order to
determine the next steps forward for this exciting new
immunotherapy. With the endorsement and recommendations from
the Advisory Board, we fully expect to file a next phase protocol
with FDA later this year."
OVATION Study Design
The Phase Ib trial will evaluate weekly
intraperitoneal dosing of GEN-1 in combination with neoadjuvant
chemotherapy, the standard of care for patients newly diagnosed
with ovarian cancer. Concurrently with neoadjuvant chemotherapy,
enrolled patients will receive 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, with interval debulking surgery
to follow. The regimen will primarily be evaluated for its safety
and tolerability.
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 Apr 2024 to May 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From May 2023 to May 2024