Celsion Announces Data Monitoring Committee Unanimously Recommends Continuation of Phase III OPTIMA Study of ThermoDox® for ...
November 30 2016 - 8:00AM
Celsion Corporation (NASDAQ:CLSN) today announced that
following a review of data from its multinational, randomized
pivotal Phase III clinical study of ThermoDox® in combination with
optimized radiofrequency ablation (RFA) for primary liver cancer
(the OPTIMA Study), the study's Data Monitoring Committee (DMC) has
unanimously recommended that the trial continue enrollment. With
approximately 40% of patients currently enrolled in the trial,
Celsion expects to complete patient enrollment in this 550 patient
trial by early 2018.
"Following the recent presentation by the NIH
confirming our hypothesis that ThermoDox® in combination with
optimized RFA can be a treatment with curative intent for HCC, we
could not be more pleased that the DMC has recommended continuation
of the OPTIMA Study without modification. Based on their review of
all the available study data, the DMC has concluded that ThermoDox
is safe for newly diagnosed, intermediate stage patients and that
the study is being conducted according to the highest of clinical
research standards," said Michael H. Tardugno, Celsion's chairman,
president and chief executive officer. "We remain optimistic and
encouraged by this decision, and by the potential that ThermoDox®
has consistently demonstrated in patients with primary liver
cancer, a patient population in dire need of new therapeutic
options."
The DMC is comprised of an independent group of
medical and scientific experts and is responsible for reviewing and
evaluating patient safety and efficacy data for the Company's Phase
III OPTIMA Study. The DMC reviews study data at regular intervals
in order to ensure the safety of all patients enrolled in the trial
and to monitor the quality and overall conduct of the trial
including each site’s compliance with the minimum RFA heating time
of 45 minutes specified in the study protocol. The OPTIMA Study’s
design and statistical plan calls for two interim analyses by the
DMC with the intent of evaluating its safety and efficacy to
determine if there is overwhelming evidence of clinical benefit or
a low probability of treatment success (a futility analysis) to
continue, modify or terminate the trial.
On November 29, 2016, the Company announced
results from an independent retrospective analysis conducted by the
National Institutes of Health (NIH) on the intent-to-treat
population of the 701 patient HEAT Study of ThermoDox® plus
optimized RFA for the treatment of primary liver cancer. The
NIH analysis, which sought to evaluate the correlation between RFA
burn time per tumor volume (min/ml) and clinical outcome, concluded
that increased burn time per tumor volume significantly improved
overall survival (OS) in patients with solitary lesions treated
with RFA + ThermoDox® compared to patients treated with RFA
alone. The NIH analysis included 437 patients with a single
lesion from the Company’s HEAT Study, the same patient population
being treated in the Company’s ongoing Phase III OPTIMA
study. These findings are consistent with Celsion’s own
analysis of the HEAT Study data, which demonstrated that over a 3.5
year period, there was a statistically significant two year
survival benefit for patients treated with ThermoDox® plus
optimized RFA over the optimized RFA only group.
About the OPTIMA Study
The Phase III OPTIMA Study is expected to enroll
up to 550 patients in up to 75 clinical sites in the United States,
Europe, China and Asia Pacific, and will evaluate 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 three to seven centimeters, versus
standardized RFA alone. The primary endpoint for the trial is
Overall Survival, which is supported by post-hoc analysis of data
from the Company's 701 patient HEAT Study, where optimized RFA has
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 (iDMC).
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 Phase II development for the treatment of
recurrent chest wall breast 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 anticancer DNA or RNA therapies, including TheraPlas™ and
TheraSilence™. The Company has a Cooperative Research and
Development Agreement (CRADA) with the NIH. Any reference to
NIH should not be viewed as an endorsement of Celsion, its products
or services. For more information on Celsion, visit our
website: http://www.celsion.com. (LTSL/ThermoDox®, HEAT Study/HCC,
OPTIMA Study/HCC)
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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