Celsion Corporation Receives Recommendation from Independent Data Monitoring Committee to Consider Stopping the Phase III OPT...
July 13 2020 - 08:30AM
Celsion Corporation (NASDAQ: CLSN), an oncology focused
drug-development company, today announced that it has received a
recommendation from the independent Data Monitoring Committee (DMC)
to consider stopping the global Phase III OPTIMA Study of
ThermoDox® in combination with radiofrequency ablation (RFA) for
the treatment of hepatocellular carcinoma (HCC), or primary liver
cancer.
The recommendation was made following the second
pre-planned interim safety and efficacy analysis by the DMC on July
9, 2020. The DMC analysis found that the pre-specified boundary for
stopping the trial for futility of 0.900 was crossed with an actual
value of 0.903. However, the 2-sided p-value of 0.524 for this
analysis provides uncertainty, subsequently, the DMC has left the
final decision of whether or not to stop the OPTIMA Study to
Celsion. There were no safety concerns noted during the interim
analysis.
“We are surprised and disappointed that the
OPTIMA Study results were not found to be more robust at this
analysis. Nonetheless, we intend to follow the advice of the DMC
and will consider our options either to stop the study or continue
to follow patients after a thorough review of the data, and an
evaluation of our probability of success. Timing for this decision
is made less urgent by the fact that the OPTIMA Study has been
fully enrolled since August 2018 and that the vast majority of the
trial expenses have already been incurred,” stated Michael H.
Tardugno, Celsion’s chairman, president and chief executive
officer.
“This, of course, is inconclusive and difficult
news for the medical community, HCC patients and our shareholders,
and confirms the complexity and challenge of treating primary liver
cancer,” he added. "The present development had never been
anticipated by the Company or our advisors based on both the first
pre-planned efficacy analysis and on tracking against the sub-group
analysis of the Company’s earlier HEAT Study upon which the OPTIMA
Study is based. We will conduct additional analyses of the
unblinded data from the trial to better understand the results and
to develop our plan going forward. As always, we wish to
acknowledge and thank all the patients and investigators for their
participation in the trial.”
The OPTIMA Study is a global, randomized,
double-blind, placebo-controlled clinical trial assessing the
efficacy of ThermoDox® in combination with RFA, which was
standardized to a minimum of 45 minutes for treating patients with
a lesion 3-7 cm in size, versus standardized RFA alone. The OPTIMA
Study enrolled 554 patients at 65 clinical sites in North America,
Europe, China and Asia Pacific. In addition to the primary overall
survival endpoint, progression-free survival, time to disease
progression, and safety are key secondary endpoints.
The statistical plan for the OPTIMA Study
included two interim efficacy analyses by the DMC. The first
interim analysis was announced in November 2019 following data lock
in August 2019 after the prescribed minimum number of 128 patient
events (deaths) was reached, and the second interim analysis was
conducted in July 2020 following data lock in April 2020 after the
prescribed minimum number of 158 events was reached.
Conference Call and Webcast
Celsion will be holding a conference call and
webcast on Wednesday, July 15 to discuss its current observations
about the results of the OPTIMA Study, the DMC’s recommendations
and the Company’s next steps. Further information regarding the
time of the call and dial-in instructions will be provided
separately.
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 ContactJeffrey
W. ChurchExecutive Vice President and CFO609-482-2455
jchurch@celsion.com
Or
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
# # #
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Feb 2024 to Mar 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Mar 2023 to Mar 2024