LAWRENCEVILLE, N.J.,
Sept. 2, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ:
CLSN), an oncology drug development company, today announced that
the first patient has been enrolled in its pivotal Phase III OPTIMA
Study of ThermoDox® in combination with optimized radiofrequency
ablation (RFA) in patients with primary liver cancer, also known as
hepatocellular carcinoma (HCC). ThermoDox® is Celsion's
proprietary, heat-activated, liposomal encapsulation of
doxorubicin.
"There is an urgent need for new treatment options that address
primary liver cancer, a rapidly progressing disease with a poor
prognosis whose worldwide incidence is growing at an alarming
rate," stated Won-Young Tak, M.D., Ph.D. at the Kyungpook
National University Hospital in
South Korea and Asia Pacific
Principal Investigator for the OPTIMA Study. "The OPTIMA Study
builds on extensive clinical and preclinical data that point to the
potential of ThermoDox®, when combined with an optimized RFA
regimen, to significantly improve patient outcomes. I look forward
to working with my colleagues to further explore the clinical
utility of ThermoDox® in this setting."
The Phase III OPTIMA Study is a global, pivotal, double-blind,
placebo-controlled clinical trial that is expected to enroll 550
patients at up to 100 sites in the North
America, Europe,
China and Asia Pacific. The study is evaluating
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. The statistical plan calls for two interim
efficacy analyses by an independent Data Monitoring Committee
(iDMC).
As of June 30, 2014, data from the
latest HEAT Study post-hoc analysis continued to strongly suggest
that ThermoDox® may significantly improve Overall Survival compared
to a RFA control in patients whose lesions undergo RFA treatment
for 45 minutes or more. These findings apply to patients with
single HCC lesions (64.4% of the HEAT Study population) from both
size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a
subgroup of 285 patients. For this group, clinical results
indicate a 57% improvement in Overall Survival, a Hazard Ratio of
0.639 (95% CI 0.419 – 0.974), and a p-value of 0.037.
"Enrollment of the first patient in our pivotal Phase III OPTIMA
Study marks a significant milestone in our effort to deliver
ThermoDox® as a novel, first-line treatment for patients with
primary liver cancer," stated Michael H.
Tardugno, Celsion's President and Chief Executive Officer.
"The trial was developed in consultation with leading primary liver
cancer, statistical and regulatory experts and is based on
extensive analysis of prior clinical and preclinical studies of
ThermoDox® plus optimized RFA. We are now focused on
successfully executing the trial, which is designed to establish a
clear path to approval in major liver cancer markets
worldwide."
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™, TheraSilence™ and RAST™. 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.
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
SOURCE Celsion Corporation