LAWRENCEVILLE, N.J.,
Aug. 6, 2015 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced updated results from its
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). As of July 15, 2015, the latest 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 58%
improvement in OS compared to optimized RFA alone. The Hazard Ratio
(HR) at this analysis is 0.63 (95% CI 0.43 – 0.93) with a p-value
of 0.0198. Median overall survival for the ThermoDox® group
has been reached which translates into a 25.4 month (2.1 year)
survival benefit over the optimized RFA group (79 months for the
ThermoDox® plus optimized RFA group versus 53.6 months for the
optimized RFA only group).
In the most recent post-hoc analysis of the HEAT Study, data
continued 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. Findings from this analysis apply to patients with
single HCC lesions (64.4% of the HEAT Study population) from both
size cohorts of the HEAT Study (3-5 cm and 5-7 cm), representing a
subgroup of 285 patients. Additional findings from this most
recent analysis specific to the Chinese cohort of patients with
single lesions (74% of the HEAT Study Chinese patient population)
showed a 75% improvement (HR = 0.57 with a p-value of 0.08) in OS
for the ThermoDox® plus optimized RFA group compared to optimized
RFA only group. Patients in the Chinese cohort with single
lesions between 3-5 cm showed a doubling of improvement (HR = 0.50
with a p-value of 0.06) in OS when treated with ThermoDox® plus
optimized RFA.
"These results from the HEAT study reinforce the potential for
ThermoDox® in combination with an optimized RFA regimen to serve as
an effective treatment option that could significantly improve
overall survival in primary liver cancer patients," stated
Dr. Nicholas Borys, Celsion's senior
vice president and chief medical officer. "The data from our
study suggests a greater than two year median survival advantage
for the ThermoDox® plus optimized RFA group, a meaningful finding
given that few treatments are effective in prolonging survival in
HCC. We look forward to continued analyses from the maturing HEAT
Study data in China and learning
more about how this regimen can prolong survival in this deadly
cancer.
"The continuing strength of the HEAT Study data reinforces our
confidence in ThermoDox® as the first and only front line
therapy for newly diagnosed HCC patients and further improves the
risk profile of our Phase III OPTIMA Study, currently enrolling
patients in 12 countries globally," said Michael H. Tardugno, Celsion's chairman,
president and chief executive officer. "Equally important is the
maturing data and the remarkable clinical benefit seen in the
Chinese patient cohort. This large 221 patient subgroup
represents a country with over 50% of the world's incidence (over
400,000 new cases) of HCC every year. These specific
findings, along with the 25.4 months improvement in time to death
seen in the global population, strengthen our options for
discussions with the CFDA to identify a faster path to
commercialization."
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
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 three 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; 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; HEAT Study data
is subject to further verification and review by the HEAT Study
Data Management Committee; the need for Celsion to evaluate its
future development plans; possible acquisitions or licenses of
other technologies, assets or businesses or the possible failure to
make such acquisitions or licenses; 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
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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