LAWRENCEVILLE, N.J.,
Feb. 24, 2014 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN) announced today that the U.S. Food and
Drug Administration (FDA) has reviewed and provided clearance for
the Company's planned pivotal, double-blind, placebo-controlled
Phase III trial of ThermoDox®, its proprietary heat-activated
liposomal encapsulation of doxorubicin in combination with radio
frequency ablation (RFA) in primary liver cancer, also known as
hepatocellular carcinoma (HCC). The trial design is based on a
comprehensive analysis of data from the Company's Phase III HEAT
Study, which demonstrated that treatment with ThermoDox resulted in
a 55% improvement in overall survival in a substantial number of
HCC patients that received an optimized RFA treatment.
Celsion expects to launch the study in the first half of 2014.
The Phase III trial, known as the OPTIMA Study, was designed
with extensive input from globally recognized HCC researchers and
clinicians, and after formal consultation with FDA. The OPTIMA
Study is expected to enroll 550 patients globally, with up to 100
sites in the United States,
Europe, China and Asia
Pacific and will evaluate ThermoDox in combination with RFA,
which will be standardized to a minimum of 45 minutes across all
investigators and sites for treating lesions 3 to 7 centimeters,
versus standardized RFA alone. The primary endpoint for the trial
is overall survival (OS). The statistical plan calls for two
interim efficacy analyses by an independent Data Monitoring
Committee (iDMC).
"ThermoDox appears to hold great promise as a first-line
treatment when used in combination with optimized RFA, for
primary liver cancer, one of the most deadly and prevalent forms of
cancer worldwide," stated Nicholas
Borys, MD, Celsion's Chief Medical Officer. "Consistency of
the retrospective data emerging from the HEAT Study over the past
year has been remarkable, and underscores the potential of
ThermoDox to extend survival in primary liver cancer patients. Now
informed by critical insights from our HEAT Study, I am confident
that the OPTIMA Study is robust, well-designed and well-supported
by HCC researchers worldwide. We look forward to initiation
and timely completion of this important study."
As reported in January 2014,
post-hoc data from the Company's HEAT Study demonstrate that
the patient subgroup in the ThermoDox arm whose RFA procedure
lasted longer than 45 minutes (285 patients or 63% of single lesion
patients), experienced a 55% improvement in overall survival, with
a Hazard Ratio of 0.64 (95% CI 0.41 - 1.00) and a P-value = 0.0495.
Median overall survival for this subgroup has not yet been reached.
Celsion will continue to follow patients in the HEAT Study on a
quarterly basis.
"FDA allowance of the Phase III OPTIMA Study represents a
significant step forward in our global development strategy for
ThermoDox and establishes a clear regulatory pathway that advances
our goal of delivering a new treatment option to patients with this
devastating and underserved disease," stated Michael H. Tardugno, Celsion's President and
CEO. "In parallel with our efforts in the
United States, we continue to advance discussions with
regulators in other important global markets, including a recent
positive meeting with China FDA (CFDA) and near-term plans to meet
with European regulatory authorities."
In support of the Company's global regulatory efforts, Celsion
recently met with CFDA to discuss the Phase III trial, including
minimum patient enrollment requirements supporting ThermoDox's
registration in China. Based on
those discussions, Celsion is submitting an application for
accelerated approval of the study in China. Celsion will expand its clinical site
footprint in Europe and plans to
meet with the European Medicines Agency (EMA) in the first half of
2014.
The HEAT Study and prior post-hoc analyses were presented at
three medical conferences in 2013, including the World Conference
on Interventional Oncology in May; the European Conference on
Interventional Oncology in June and the International Liver Cancer
Association Annual Conference in September. Presentations
were made by some of the most highly recognized liver cancer
researchers and key HEAT Study investigators. Quarterly
overall survival data analyses have been conducted with the full
support of these researchers and clinical investigators.
About Celsion Corporation
Celsion is dedicated to the development and commercialization of
innovative cancer drugs, including tumor-targeting treatments using
focused heat energy in combination with heat-activated liposomal
drug technology. Celsion has research, license or
commercialization agreements with leading institutions, including
the National Institutes of Health, Duke
University Medical Center, University
of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the
Kyungpook National University Hospital,
the Beijing Cancer Hospital and the University of Oxford. For
more information on Celsion, visit our website:
http://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, particularly
in small subgroups; FDA and regulatory uncertainties and risks; the
significant expense, time, and risk of failure of conducting
clinical trials; HEAT Study data is subject to further verification
and review by the HEAT Study Data Management Committee; the need
for Celsion to evaluate its future development plans; possible
acquisitions or licenses of other technologies, assets or
businesses or the possible failure to make such acquisitions or
licenses; possible actions by customers, suppliers, competitors,
regulatory authorities; and other risks detailed from time to time
in the 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
SOURCE Celsion Corporation