LAWRENCEVILLE, N.J.,
Nov. 5, 2014 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN) announced today that the Phase III
OPTIMA Study was approved via Europe's centralized Voluntary Harmonization
Procedure (VHP). The approval allows Celsion to conduct the
OPTIMA Study, its Phase III trial of ThermoDox® in primary liver
cancer, also known as hepatocellular carcinoma (HCC), in
Europe. In addition to Italy, the OPTIMA Study will now include sites
in Spain and Germany. The
OPTIMA Study is the Company's global pivotal, double-blind,
placebo-controlled trial, evaluating ThermoDox®, Celsion's
proprietary heat-activated liposomal encapsulation of doxorubicin,
in combination with radiofrequency ablation standardized to 45
minutes (sRFA) versus sRFA alone to treat patients with
non-resectable HCC lesions. HCC is the largest unmet medical need
remaining in oncology with annual incidence over 750,000 and
non-resectable RFA candidates representing some 30% of the newly
diagnosed patients. The OPTIMA Study is actively recruiting and
enrolling patients at sites in the United
States, Hong Kong,
South Korea, Malaysia and Thailand. Additional
clinical sites in Canada,
Taiwan, and the Philippines are expected to begin
recruitment before the end of the year with China FDA (CFDA)
regulatory approval to follow in early 2015.
"This approval allows us to expand our clinical program into key
European countries, a critical element of our strategy to ensure
study participation and thought leader support in major liver
cancer markets worldwide," said Michael H.
Tardugno, Celsion's Chairman, President and Chief
Executive Officer. "We are aggressively recruiting
patients at sites in North America
and the Asia Pacific region, and
continue to pursue additional clinical trial application approvals
in other key markets to further support this global trial."
The Phase III OPTIMA Study is expected to enroll up to 550
patients globally, in up to 100 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 sites for treating lesions 3 to 7 centimeters, versus
standardized RFA alone. The primary endpoint for the trial is
overall survival (OS), which is supported by post-hoc analysis of
data from the Company's 701 patient HEAT Study, where optimized RFA
has demonstrated 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.
The pipeline also includes EGEN-001, a DNA-based immunotherapy for
the localized treatment of ovarian and brain cancers. Celsion
has three platform technologies for the development of novel
nucleic acid-based immunotherapies and other anti-cancer DNA or RNA
therapies, including TheraPlas™ and TheraSilence™. 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 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 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.
Investor Contact
Jeffrey W. Church
Senior Vice President and
Chief Financial Officer
609-482-2455
jchurch@celsion.com
SOURCE Celsion Corporation