Celsion Presents Data on ThermoDox® plus Optimized RFA in Intermediate Primary Liver Cancer at the 3rd Asian Conference on T...
October 31 2016 - 9:00AM
Celsion Corporation (NASDAQ:CLSN), an oncology drug development
company, today announced the presentation of data from the
Company’s HEAT Study, highlighting the curative potential for
ThermoDox® plus optimized radiofrequency ablation (RFA) in
intermediate primary liver cancer, also known as hepatocellular
carcinoma (HCC). The clinical data were presented by a leading
liver cancer expert from South Korea, Professor Won Young Tak,
M.D., Ph.D., Division of Gastroenterology and Hepatology,
Department of Internal Medicine, School of Medicine, Kyungpook
National University, Daegu, Republic of Korea, on October 29, 2016
at the 3rd Asian Conference on Tumor Ablation (ACTA) in Seoul,
Korea. Dr. Hyunchul Rhim from Samsung Medical Center in
Soeul, Korea, is the Chairman of the 3rd ACTA Conference and a
principal investigator on the Company’s OPTIMA Study.
Professor Tak's presentation, entitled
“Thermo-Sensitive Drug Assisted Ablation,”
highlighted data from Celsion's latest HEAT Study post-hoc
analysis, which suggests an overall survival benefit of over two
years in the large subgroup of patients treated with ThermoDox®
plus optimized RFA (RFA ≥ 45 minutes) as well as findings from
preclinical studies demonstrating a direct correlation between the
duration of RFA heating, or dwell time, and the concentration of
doxorubicin localized to the liver.
“There is clear evidence that the duration of
the RFA regimen is critical when treating patients with ThermoDox,
and the totality of the data presented to date demonstrate that
ThermoDox plus optimized RFA has a strong potential to serve as a
curative therapy for patients with liver cancer,“ said Professor
Tak, lead investigator in South Korea for the Company's HEAT and
OPTIMA studies. “The OPTIMA trial is designed to validate this
approach in an indication where there exists a strong unmet need
for effective treatment options.”
The Phase III OPTIMA study is a global pivotal,
double-blind, placebo-controlled study evaluating 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.
"Our OPTIMA Study investigators continue to
recognize the value of findings from the HEAT study, and their
continued interest reinforces substantial and mounting support for
and the de-risking of our ongoing global Phase III OPTIMA Study,"
said Michael H. Tardugno, Celsion's chairman, president and chief
executive officer. “The recent independent analysis conducted by
the National Institutes of Health provides further confirmatory
support indicating that the use of RFA for more than 45 minutes in
patients treated with ThermoDox can have a correlative impact on
reductions in tumor size and overall survival in patients with
primary liver cancer.”
Professor Tak’s presentation will be available
on Celsion’s website under “News & Events – Scientific
Presentations.”
Celsion notes that NIH’s analysis will be
discussed in detail during an oral session on Monday, November 28,
2016 at 1:50 pm CT during the 102nd Scientific Assembly and Annual
Meeting of the Radiological Society of North America (RSNA) to be
held on November 26 – December 2, 2016 in Chicago, IL.
About Celsion’s Phase III OPTIMA
Study
Celsion's Phase III OPTIMA Study is a global
pivotal, double-blind, placebo-controlled study. The study is
expected to enroll up to 550 patients in over 75 clinical sites in
the North America, 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 for the OPTIMA
Study 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™. For more information on Celsion, visit our website:
http://www.celsion.com. (LTSL/ThermoDox®, HEAT Study/HCC, Optima
Study/HCC)
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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