Celsion Corporation Announces Final Overall Survival Data from HEAT Study of ThermoDox® in Primary Liver Cancer
15 August 2016 - 10:00PM
Subgroup Data Continue to Show a Statistically
Significant Improvement in Overall Survival, Consistent With a Two
Year Median Survival Benefit Following Treatment with ThermoDox®
plus Optimized RFA
Celsion Corporation (NASDAQ:CLSN) today announced updated results
from its final retrospective analysis of the Company's 701-patient
HEAT Study of 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 overall survival (OS)
analysis demonstrated that in a large, well bounded, subgroup of
patients (n= 285, 41% of the HEAT Study patients), treatment with a
combination of ThermoDox® and optimized RFA provided an average 54%
risk improvement in OS compared to optimized RFA alone. The Hazard
Ratio (HR) at this analysis is 0.65 (95% CI 0.45 - 0.94) with a
p-value of 0.02. Median overall survival for the ThermoDox®
group has been reached which translates into a two year survival
benefit over the optimized RFA only group (projected to be greater
than 80 months for the ThermoDox® plus optimized RFA group compared
to less than 60 months projection for the optimized RFA only
group).
Additional findings from this most recent
analysis specific to the Chinese patient cohort of 223 patients are
summarized below:
- In the population of 154 patients with single lesions (70% of
the HEAT Study Chinese patient cohort) who received optimized RFA
treatment for 45 minutes or more showed a 53% risk improvement in
OS (HR = 0.66) when treated with ThermoDox® plus optimized
RFA.
- These data continue to support and further strengthen
ThermoDox®'s potential to significantly improve OS compared to an
RFA control in patients with lesions that undergo optimized RFA
treatment for 45 minutes or more. The clinical benefit seen
in the ITT Chinese patient cohort further confirms the importance
of RFA heating time as 72% of patients in this large patient cohort
in China received an optimized RFA treatment.
“Data from the HEAT Study have consistently been
a foundation and provides additional evidence for our thesis that
ThermoDox®, when combined with RFA standardized to a minimum of 45
minutes for intermediate size lesions has the potential to
significantly improve survival in primary liver cancer, where the
current overall survival rate is far too short,” stated Nicholas
Borys, M.D., Celsion's senior vice president and chief medical
officer. “These findings, if borne out in our ongoing OPTIMA trial,
will position ThermoDox® as a potentially curative treatment in
primary liver cancer.”
“We are delighted to present our investors and
the medical community with the findings from the final data sweep
from the HEAT Study which reinforces the substantial and mounting
support for our ongoing global Phase III OPTIMA Study,” said
Michael H. Tardugno, Celsion's chairman, president and chief
executive officer. “Particularly, with the growing incidence of
primary liver cancer in China representing approximately 50% of the
850,000 cases diagnosed annually, the data generated from the
Chinese subgroup underscore the importance of ThermoDox® and the
role that it will play as a first line therapy for this, the
largest unmet medical need in oncology. Along with our China
focused manufacturing strategy, the results from the HEAT Study
will support our regulatory and long-term commercialization
strategy for ThermoDox® in this important region.”
The OPTIMA Study is a pivotal, double-blind,
placebo-controlled Phase III clinical trial, and is expected to
enroll up to 550 patients at up to 75 sites in the North America,
Europe, China and Asia Pacific. As of July 31, 2016, the study has
been successfully enrolling patients at more than 57 clinical sites
in 13 different countries. In December 2015, Celsion 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 15 additional clinical sites in China, the country
where approximately 50% of the 850,000 new cases of primary liver
cancer are diagnosed each year and where 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.
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
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Apr 2024 to May 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From May 2023 to May 2024