LAWRENCEVILLE, N.J.,
Feb. 23, 2015 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN) 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 January 15, 2015, the latest quarterly overall
survival (OS) analysis demonstrated that in a large, well bounded,
subgroup of patients (n=285, 41% of the study patients), the
combination of ThermoDox® and optimized RFA provided a 59%
improvement in OS compared to optimized RFA alone. The Hazard Ratio
at this analysis is 0.628 (95% CI 0.420 – 0.939) with a p-value of
0.02.
"The consistency of the data from the HEAT Study over the past
two years is quite compelling, demonstrating the significant
potential for ThermoDox® in combination with an optimized RFA
regimen to markedly improve overall survival in primary liver
cancer patients," stated Riccardo
Lencioni, MD, FSIR, EBIR, professor and director of the
diagnostic imaging and intervention at the Pisa University School
of Medicine in Italy. "These findings provide a strong
rationale for the ongoing OPTIMA Study and may also underscore the
interest of clinical investigators to evaluate the potential of
ThermoDox plus optimized RFA for curative intent among intermediate
stage HCC patients."
The data from the most recent quarterly HEAT Study post-hoc
analysis continued to strongly suggest that ThermoDox® may
significantly improve OS compared to a RFA control in patients
whose lesions undergo optimized 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.
"Once again, our quarterly OS analysis of the HEAT Study data
shows a meaningful, statistically significant survival benefit
among patients treated with ThermoDox® plus optimized RFA versus
optimized RFA alone, further underscoring our confidence in the
protocol for our ongoing Phase 3 OPTIMA trial," stated Michael H. Tardugno, Celsion's chairman,
president and chief executive officer. "The lessons learned from
the HEAT study together with prospective supportive preclinical
study results formed the basis for our global Phase III OPTIMA
Study evaluating ThermoDox® in combination with a standardized RFA
protocol in primary liver cancer, and we look forward to sharing
this latest data update with our investigators worldwide as we
continue to advance this program."
The Phase III OPTIMA Study is expected to enroll up to 550
patients globally in up to 100 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 3 to 7 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).
"Investigators from 14 countries have demonstrated their
confidence in ThermoDox plus optimized RFA," noted Nicholas Borys, MD, Celsion's senior vice
president and chief medical officer. "The consistent and
improving evidence of an overall survival benefit not only
reinforces their interest, but also suggests that ThermoDox should
be considered conditionally in patients presenting with
unresectable, intermediate stage disease."
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 three platform technologies for the
development of novel nucleic acid-based immunotherapies and other
anti-cancer DNA or RNA therapies, including TheraPlas™,
TheraSilence™ and RAST ™. 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 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
Senior Vice President and CFO
609-482-2455
jchurch@celsion.com
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SOURCE Celsion Corporation