Celsion Reports that Sufficient Events Have Been Reached for the Second Interim Analysis of the Phase III OPTIMA Study of The...
April 15 2020 - 8:30AM
Celsion Corporation
(NASDAQ: CLSN), an oncology
drug-development company, announces that the prescribed minimum
number of events of 158 patient deaths has been reached for the
second pre-specified interim analysis of the OPTIMA Phase III Study
with ThermoDox® plus RFA (radiofrequency ablation) in patients with
hepatocellular carcinoma (HCC), or primary liver cancer. Following
preparation of the data, the Independent Data Monitoring Committee
(iDMC) is expected to meet in July to conduct the second interim
analysis. Celsion expects to announce iDMC recommendations as soon
as possible after the meeting.
The hazard ratio for success at 158 deaths is
0.70, which represents a 30% reduction in the risk of death
compared with RFA alone. This compares favorably with the hazard
ratio of 0.65 observed in the prospective HEAT Study subgroup upon
which the OPTIMA Study is based.
Michael Tardugno, Celsion’s chairman, president
and chief executive officer, said, “We look forward to receiving
the iDMC’s recommendation from this data analysis, and are quite
optimistic for a positive outcome. Regardless, we believe that the
OPTIMA Study is ultimately well-positioned for success. If a final
analysis is necessary, it will be based on 197 patient deaths where
the hazard ratio for success of 0.75 represents a significantly
lower hurdle than the hazard ratio that was observed in the
prospective HEAT Study subgroup. We base our confidence on
published pre-clinical data supporting the OPTIMA Study, the
National Institutes of Health’s independent analysis of and support
for the Study’s hypothesis, and the OPTIMA Study’s current timeline
for disease progression and patient death, both tracking in line
with the prospective HEAT Study subgroup. The prospective subgroup
demonstrated a remarkable 7 ½ years plus survival when treated with
ThermoDox® plus RFA. A successful study has “blockbuster” revenue
potential and more importantly, will be transformational for
patients with HCC, with over 750,000 incidence annually, the
largest unmet need in oncology.”
The OPTIMA Study was fully enrolled in August
2018 with 556 subjects from 65 clinical sites in 14 countries. The
design of the OPTIMA Study is based on the Company’s HEAT Study, in
which a prospective subgroup analysis of 285 subjects received a
single ThermoDox® administration in combination with a 45 minute or
longer RFA procedure in patients with a single lesion of 3-7 cm in
size. Followed prospectively for 3 years, those patients treated
with ThermoDox demonstrated a median survival of more than 7 ½
years and a survival benefit of more than 2 years over the control
group. These data were published in the October 2017 issue of the
peer-reviewed journal Clinical Cancer Research, and are available
here.
In November 2019, Celsion announced the iDMC
evaluation of the safety and data integrity for all 556 patients
enrolled in the OPTIMA Study in its first pre-planned interim
analysis following 128 events, which occurred in August 2019.
During that review the iDMC unanimously recommended that the OPTIMA
Study continue as planned. That data review demonstrated:
- The OPTIMA Study patient
demographics and risk factors are consistent with what the Company
observed in the HEAT Study subgroup with all data quality metrics
meeting expectations.
- Median PFS for the OPTIMA Study
reached 17 months as of August 2019. These blinded data compare
favorably with 16 months median PFS for the 285 patients in the
HEAT Study subgroup of patients treated with RFA >45 minutes and
followed prospectively for overall survival.
- Median OS for the OPTIMA Study had
not been reached as of August 5, 2019; however, median OS appears
to be consistent with the HEAT Study subgroup of patients treated
with RFA >45 minutes and followed prospectively for overall
survival.
About the OPTIMA Study
The Phase III OPTIMA Study enrolled 556 patients
at 65 clinical sites in North America, Europe, China and Asia
Pacific. The Study is evaluating ThermoDox® in combination with
optimized RFA, which will be standardized to a minimum of 45
minutes across all investigators and clinical sites for treating
lesions 3-7 cm in size, versus optimized RFA alone. The primary
endpoint for the trial is Overall Survival, which is supported by
post-hoc analyses of data from the Company's 701-patient HEAT
Study, where optimized RFA demonstrated the potential to
significantly improve survival when combined with ThermoDox®. The
statistical plan calls for two interim efficacy analyses by an
independent Data Monitoring Committee.
About ThermoDox®
Celsion’s most advanced program is a
heat-mediated drug delivery technology that employs a novel
heat-sensitive liposome engineered to address a range of
difficult-to-treat cancers. The first application of this platform
is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD)
whose novel mechanism of action delivers high concentrations of
doxorubicin to a region targeted with the application of localized
heat at 40°C, just above body temperature. ThermoDox® is positioned
for use with multiple heating technologies and has the potential to
treat of a broad range of cancers including metastatic liver,
recurrent chest wall breast cancer and non-muscle invading bladder
cancers.
Celsion’s LTLD technology leverages two
mechanisms of tumor biology to deliver higher concentrations of
drug directly to the tumor site. In the first mechanism, rapidly
growing tumors have leaky vasculature, which is permeable to
liposomes and enables their accumulation within tumors. Leaky
vasculature influences a number of factors within the tumor,
including the access of therapeutic agents to tumor cells.
Administered intravenously, ThermoDox® is engineered with a
half-life to allow significant accumulation of liposomes at the
tumor site as these liposomes recirculate in the blood stream.
In the second mechanism, when an external
heating device heats tumor tissue to a temperature of 40°C or
greater, the heat-sensitive liposome rapidly changes structure and
the liposomal membrane selectively dissolves, creating openings
that can release a chemotherapeutic agent directly into the tumor
and the surrounding vasculature. Drug concentration increases as a
function of the accumulation of liposomes at the tumor site, but
only where the heat is present. This method damages only the tumor
and the area subject to tumor invasion, supporting more precise
drug targeting.
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 development for other cancer indications. The
Company’s product 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.
Forward-looking Statements
Forward-looking statements in this news 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 or regulatory authorities; and
other risks detailed from time to time in the Celsion's periodic
filings 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. ChurchExecutive Vice President and
CFO609-482-2455 jchurch@celsion.com
Or
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
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