Celsion Corporation Announces Progress with ThermoDox® Development Efforts in China and Asia Pacific
December 16 2016 - 1:30PM
CFDA Indicates that Positive Phase III OPTIMA
Data Could Support Direct Regulatory Filing in China
Celsion Corporation (NASDAQ:CLSN) today provided an update on
its Phase III OPTIMA program for ThermoDox®, Celsion's proprietary
heat-activated liposomal encapsulation of doxorubicin in
combination with radiofrequency ablation (RFA) in primary liver
cancer, also known as hepatocellular carcinoma (HCC). The Phase III
OPTIMA Study is expected to enroll up to 550 patients at up to 75
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 clinical sites for treating lesions three to
seven centimeters, versus standardized RFA alone.
The Company recently met with the China Food and
Drug Administration (CFDA) to discuss the ongoing Phase 3 OPTIMA
program and regulatory pathway for ThermoDox in China. During the
meeting, Celsion presented the final overall survival data from the
Chinese patient cohort of the HEAT study, which demonstrated a
survival benefit in patients treated with ThermoDox plus optimized
RFA versus optimized RFA alone. The CFDA informed Celsion that if
the ongoing Phase 3 OPTIMA trial is successful, the trial could
serve as the basis for a direct regulatory filing in China without
the need to file for prior approval in the U.S. or European Union
which is currently required for foreign company application. This
would allow the Company to accelerate its plans for a regulatory
filing in China and, if approved, provide for a significantly
earlier launch date in China than originally expected.
“We are building momentum with our efforts for
ThermoDox in the Asia Pacific region, particularly China, which
represents a significant market opportunity with over 50% of new
diagnosed cases of this devastating cancer,” stated Michael H.
Tardugno, Celsion's chairman, president and chief executive
officer. “All Chinese sites will be fully activated by early 2017,
enrollment is on pace to meet our objective of fully enrolling the
trial by the first quarter of 2018, and we have advanced our
manufacturing in China with Hisun to support a potential future
launch in this region with impressive gross margins. We believe
that the remarkable data from the Chinese cohort of the HEAT study
underscores the potentially curative nature of ThermoDox in
patients with primary liver cancer, and we are pleased that the
CFDA has both recognized its potential and offered a
straightforward path to a regulatory filing in China.”
In support of its efforts in China, Celsion
reported that recent bioequivalence studies of ThermoDox produced
in China by Hisun are equivalent to batches of ThermoDox produced
at its United States manufacturing site.
In addition, Celsion reported that the Company’s
management team recently met with the Ministry of Health in Vietnam
and based on that meeting, it will move forward with launching
additional trial sites for the OPTIMA study in the country. Celsion
expects to have approximately 5 additional clinical trial sites in
Vietnam activated by early 2017. Vietnam represents a significant
market for ThermoDox where HCC incidence rates are among the
world’s highest.
About the OPTIMA Study
The Phase III OPTIMA Study is expected to enroll
up to 550 patients in up to 75 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 clinical sites
for treating lesions three to seven centimeters, versus
standardized RFA alone. The primary endpoint for the trial is
Overall Survival, which is supported by post-hoc analysis of data
from the Company's 701 patient HEAT Study, where optimized RFA has
demonstrated the 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 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 anticancer DNA or RNA therapies, including TheraPlas™ and
TheraSilence™. The Company has a Cooperative Research and
Development Agreement (CRADA) with the NIH. Any reference to NIH
should not be viewed as an endorsement of Celsion, its products or
services.
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; possible actions by customers, suppliers, competitors,
regulatory authorities; and other risks detailed from time to time
in 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
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