LAWRENCEVILLE, N.J.,
Jan. 27, 2014 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN) today announced that the
latest overall survival data from its post-hoc analysis of results
from the Company's Phase III HEAT Study of ThermoDox®, Celsion's
proprietary heat-activated liposomal encapsulation of doxorubicin
in combination with radio frequency ablation (RFA), supports the
continued clinical development of ThermoDox® in a prospective
pivotal Phase III Study, subject to regulatory review and
agreement. This analysis followed the announcement on January 31, 2013, that the HEAT Study did not
meet its primary endpoint, progression-free survival (PFS).
As provided for in the HEAT Study's Special Protocol Assessment
(SPA) agreement with the U.S. Food and Drug Administration (FDA),
the Company continues to follow patients for overall survival, the
secondary endpoint of the Study. Data from four quarterly
reviews of overall survival have been evaluated since the
announcement of top line PFS data.
Data from the updated HEAT Study analysis suggests that
ThermoDox® may significantly improve overall survival, compared to
control, in patients whose lesions undergo RFA treatment for 45
minutes or more. These findings 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) and represent a
subgroup of 285 patients (41% of the patients in the HEAT
Study). Updated OS data from this subgroup of patients is
summarized below:
- In the patient subgroup treated in the ThermoDox® arm, whose
RFA procedure lasted longer than 45 minutes (285 patients or 63% of
single lesion patients) clinical results indicate a 55% improvement
in overall survival, a Hazard Ratio of 0.64 (95% CI 0.41 – 1.00)
and a P-value = 0.0495. Median overall survival for this subgroup
has not yet been reached.
- In contrast, the patient subgroup treated with ThermoDox® whose
RFA procedure lasted less than 45 minutes in duration (167 patients
or 37% of single lesion patients) indicated a Hazard Ratio of 1.12
(95% CI 0.68 – 1.86) and a P-value = 0.66. Median overall
survival for this subgroup has not yet been reached.
- The Hazard Ratios reported above warrants additional clinical
development and should be viewed with caution since they are based
on a retrospective analysis and the HEAT Study has not reached its
median point for overall survival analysis. Celsion will
continue to follow patients in the HEAT Study to the secondary
endpoint, overall survival, and will update the subgroup analysis
based on RFA heating duration.
"The HEAT Study post-hoc data is compelling. The
combination of ThermoDox® and an optimized RFA treatment appears to
have a significant improvement in overall survival in HCC
patients," stated Dr. Nicholas
Borys, Celsion's Chief Medical Officer. "While this
conclusion is reached based on a post-hoc evaluation, it is
nonetheless supported by the consistency of the data seen over a
one year follow-up period, and by what is now a statistically
significant outcome for overall survival. Our investigators
are convinced that RFA can and should be optimized in future
trials."
The HEAT Study and prior post-hoc analyses were presented at
three medical conferences in 2013, including the World Conference
on Interventional Oncology in May; the European Conference on
Interventional Oncology in June and the International Liver Cancer
Association Annual Conference in September. Presentations
were made by some of the most highly recognized liver cancer
researchers and key HEAT Study investigators. Quarterly
overall survival data analyses have been conducted with the full
support of these researchers and clinical
investigators.
Additionally, Celsion has been consulting with its clinical
advisors, regulatory and expert statistician consultants and the
FDA regarding the study design and statistical plan for its
proposed pivotal Phase III clinical trial. The Company
anticipates initiating a multicenter global trial in the first half
of 2014.
"These data continue to support our strong interest in
ThermoDox® and its potential as a first line treatment for a
significant percentage of the world's 750,000 newly diagnosed HCC
patients," noted Michael H.
Tardugno, Celsion's President and Chief Executive Officer.
"In addition to the FDA, the Company is pursuing regulatory
approval of its new Phase III clinical trial in multiple countries,
particularly those where HCC's prevalence represents an important
health issue. In parallel with this effort, we are recruiting
key CRO partners to initiate the Study rapidly following regulatory
agency agreement. With our strong financial resources and the
support of the global HCC community, we are confident in our
ability to conduct a timely and cash efficient pivotal
program."
About Celsion Corporation
Celsion is dedicated to the development and commercialization of
innovative cancer drugs, including tumor-targeting treatments using
focused heat energy in combination with heat-activated liposomal
drug technology. Celsion has research, license or
commercialization agreements with leading institutions, including
the National Institutes of Health, Duke
University Medical Center, University
of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the
Kyungpook National University Hospital,
the Beijing Cancer Hospital and the University of Oxford. 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.
Investor Contact
Jeffrey W.
Church
Senior Vice President and
Chief Financial Officer
609-482-2455
jchurch@celsion.com
SOURCE Celsion Corporation