LAWRENCEVILLE, N.J.,
Dec. 16, 2015 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN) today announced that it has received
Clinical Trial Application (CTA) approval from the China Food and
Drug Administration (CFDA) to conduct the ongoing Phase III OPTIMA
Study at clinical sites in China.
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 primary liver cancer, also known
as hepatocellular carcinoma (HCC). Celsion Corporation is a
fully-integrated oncology company focused on the development of a
portfolio of innovative cancer treatments, including directed
chemotherapies, immunotherapies and RNA- or DNA-based therapies for
the treatment of cancer and other difficult-to-treat
diseases.
"The OPTIMA Study is the only global Phase III clinical trial
being conducted in HCC, and the China market is an important element of our
global development strategy for ThermoDox®, representing
approximately 50% of the 850,000 new cases of primary liver cancer
diagnosed each year," noted Michael H.
Tardugno, Celsion's chairman, president and chief
executive officer. "We believe that this approval by the China FDA
represents another important validation of our development program
for ThermoDox®, which shows the potential for improvement in
overall survival in HCC patients. This approval also positions us
as a leader in research in a major global market for primary liver
cancer," Mr. Tardugno said.
The Phase III 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. The CTA approval will now allow Celsion to enroll
patients at up to 25 additional clinical sites in China. With the addition of these Chinese
clinical sites, the Company expects to complete enrollment in the
OPTIMA Study by the end of 2017. Results from the OPTIMA Study, if
successful, will provide the basis for a global registration filing
and marketing approval.
The primary endpoint for the OPTIMA Study is overall survival
(OS). The statistical plan calls for two 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 OS in the ThermoDox® plus standardized RFA arm
was approximately 80 months, which is considered a curative
treatment for HCC.
"There is significant interest in the curative potential for
ThermoDox® among leading liver cancer experts in China and the world, and we have a number of
highly-motivated sites eager to enroll patients in this important
study," Mr. Tardugno added. "We are aggressively recruiting
patients worldwide, and look forward to building our relationships
with these key study sites in China as the trial progresses."
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.
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; FDA and regulatory uncertainties and risks; the
significant expense, time, and risk of failure of conducting
clinical trials; possible acquisitions or licenses of other
technologies, assets or businesses; possible actions by 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
806-483-1721
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation