Celsion Reports Unanimous Independent Data Monitoring Committee Recommendation to Continue the Phase III OPTIMA Study of Ther...
November 04 2019 - 8:00AM
Celsion Corporation
(NASDAQ:
CLSN), an oncology drug
development company, today announced that the independent Data
Monitoring Committee (iDMC) has unanimously recommended the OPTIMA
Study continue according to protocol. The recommendation was based
on a review of blinded safety and data integrity from 556 patients
enrolled in the Company’s multinational, double-blind,
placebo-controlled pivotal Phase III study with ThermoDox® plus RFA
(radiofrequency ablation) in patients with hepatocellular carcinoma
(HCC), or primary liver cancer (the OPTIMA Study).
The iDMC pre-planned interim efficacy review
followed 128 patient events, or deaths, which occurred in August
2019. Data presented demonstrated that PFS and OS data appear to be
tracking with patient data observed at a similar point in the
Company’s subgroup of patients followed prospectively in the
earlier Phase III HEAT Study, upon which the OPTIMA Study is
based.
The data review demonstrated the following:
- 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 17.3 months as of August 2019. These blinded data compare
favorably with 16.8 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.
- At this time point, combined
Overall Survival (OS) for both treatment arms is consistent with
that observed in the 285 patient prospective HEAT Study
subgroup.
- The OPTIMA Study has lost only 4
patients to follow-up from the initiation of the trial in September
2014 through August 2019; the trial design allows for 3% loss per
year.
Michael H. Tardugno, Celsion’s chairman,
president and chief executive officer, said, “We are encouraged by
the recommendation of the iDMC to continue the OPTIMA Study
according to plan. While we have not unblinded the study to report
a hazard ratio, PFS is tracking similarly to the subgroup of
patients who received more than 45 minutes of RFA in our HEAT Study
and were followed prospectively for more than three years. This
subgroup in the HEAT Study demonstrated a 2-year overall survival
advantage and a median time to death of more than 7 ½ years. We
believe this tracking bodes well for success at our next
pre-planned interim efficacy analysis, which is intended after a
minimum of 158 patient deaths. We also note that the median
follow-up for survival was only 25 months at time of data cut-off,
which is too early for OS estimates, particularly when compared to
the median follow-up for the HEAT Study subgroup which was 67
months. The OPTIMA Study, like other oncology studies, is subject
to tumor progression, and the timing of efficacy results is
entirely event driven. We estimate that our next interim safety and
efficacy analysis will occur during the second quarter of
2020.”
“The hazard ratio for success at 158 events is
0.70. This is below the hazard ratio of 0.65 observed for the 285
patients in the HEAT Study subgroup of patients treated with RFA
> 45 minutes,” Mr. Tardugno added.
The iDMC reviews study data at regular
intervals, with the primary responsibilities of ensuring the safety
of all patients enrolled in the study, the quality of the data
collected and the continued scientific validity of the study
design.
About the OPTIMA STUDY
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 subgroup analysis of 285 subjects received a single
ThermoDox® administration in combination with a 45 minute or longer
RFA procedure in HCC 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.
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 higher, 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. The 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. For more information on Celsion, please visit
www.celsion.com.
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; 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. ChurchExecutive Vice President and CFO609-482-2455
jchurch@celsion.com
Or
LHA Investor RelationsKim Sutton
Golodetz212-838-3777kgolodetz@lhai.com
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