LAWRENCEVILLE, N.J.,
April 26, 2016 /PRNewswire/ --
Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced that the first patient in
China has been enrolled in its
ongoing global Phase III OPTIMA Study 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 newly
diagnosed patients with primary liver cancer, also known as
hepatocellular carcinoma (HCC).
The pivotal, double-blind, placebo-controlled OPTIMA Study is
expected to enroll up to 550 patients globally, and has been
successfully enrolling patients at 50 clinical sites in 12
different countries in North
America, Europe and
Asia Pacific. In December 2015, the Company announced that it had
received a Clinical Trial Application (CTA) approval from the China
Food and Drug Administration (CFDA) to conduct the OPTIMA Study at
up to 20 additional clinical sites in China. The Company aims to enroll more than
200 patients in the China
territory, the minimum number required by the CFDA to file a New
Drug Application (NDA), assuming positive clinical results.
"The enrollment of the first patient in China represents a significant milestone for
the OPTIMA program," said Michael H.
Tardugno, Celsion's chairman, president and chief executive
officer. "With the growing incidence of primary liver cancer
in China, representing
approximately 50% of the 850,000 cases diagnosed annually, this
country is an important element of our global registration and
commercialization strategy for ThermoDox®, and we are committed to
driving patient enrollment in this region as we execute our OPTIMA
study."
"Survival data from the subgroup analysis in the HEAT study
underscore the potential of ThermoDox® in combination with sRFA to
serve as a potentially curative treatment in primary liver cancer,
where very limited treatment options currently exist," said Dr.
Nicholas Borys, Celsion's chief
medical officer. "We look forward to working with our
colleagues in China and the global
research team to further explore ThermoDox® in this setting."
The primary endpoint for the OPTIMA Study is overall survival
(OS). The statistical plan calls for two preplanned interim
efficacy analyses by an independent Data Monitoring Committee
(iDMC). The design of the OPTIMA Study is supported by a
retrospective analysis of a large subgroup of 285 patients in the
Company's previous 701 patient HEAT Study in primary liver cancer.
In a subgroup of 285 HEAT Study participants, ThermoDox® plus
standardized RFA demonstrated a statistically significant
improvement in survival of over two years compared to standardized
RFA alone. In this large subgroup, the median overall survival in
the ThermoDox® plus standardized RFA arm was approximately 80
months (6 ½ years), which is considered a curative treatment for
HCC.
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
anti-cancer DNA or RNA therapies, including TheraPlas™ and
TheraSilence™. For more information on Celsion, visit our
website: http://www.celsion.com. (CLSN-TD) (CLSN-OS)
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 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
Celsion Media Contacts
Harriet Shelare
Director, Communications
860-483-1721
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation