Celsion Announces FDA Clearance of the OPTIMA Study - A Pivotal Phase III Trial of ThermoDox in Primary Liver Cancer

  Celsion Announces FDA Clearance of the OPTIMA Study - A Pivotal Phase III
                  Trial of ThermoDox in Primary Liver Cancer

Study Developed in Consultation with Clinical Advisors, Statistical Experts
and FDA

Compelling Survival Data Supports Development

Trial Advances Global Regulatory Strategy in Key Markets

PR Newswire

LAWRENCEVILLE, N.J., Feb. 24, 2014

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

Website: http://www.celsion.com
 
Press spacebar to pause and continue. Press esc to stop.