LAWRENCEVILLE, N.J.,
Sept. 8, 2015 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced highlights from presentations
by three leading experts in the treatment of intermediate primary
liver cancer, also known as hepatocellular carcinoma (HCC) and
Celsion's pivotal Phase III OPTIMA Study of ThermoDox®, the
Company's proprietary heat-activated liposomal encapsulation of
doxorubicin, in combination with optimized radiofrequency ablation
(RFA). The symposium, entitled "Intermediate HCC: Cure vs.
Palliation," was held on September 5,
2015 at the International Liver Cancer Association (ILCA)
9th Annual Conference in Paris, France and was moderated by Professor
Riccardo Lencioni, MD, FSIR, EBIR,
Executive Committee member of the ILCA Governing Board.
The three presentations included:
- "Current Management of Intermediate HCC: Unmet Medical
Needs," by Ronnie T.P. Poon,
MD, MBBS, MS, PhD, FRCS (Edin), FACS, Medical Director at the Hong
Kong Integrated Oncology Center, Honorary Professor of Surgery at
the University of Hong Kong Queen Mary
Hospital, and member of the ILCA Governing Board. Dr. Poon
discussed strategies for treating different stages of HCC including
intermediate stage HCC which has been previously thought to be
incurable. New treatment strategies, most notably an optimized RFA
procedure with the investigational drug, ThermoDox®, show clear
promise as a potential cure for intermediate HCC in the years
ahead.
- "Intermediate HCC Treatment Paradigms and Lessons
Learned," by Ghassan K. Abou-Alfa, MD, Professor at
Memorial Sloan Kettering Cancer Center. Dr. Abou-Alfa reviewed
results from recent clinical studies in intermediate stage primary
liver cancer patients, including recent data from Celsion's latest
HEAT Study post-hoc analysis which suggests an overall survival
benefit of more than two years in the large subgroup of patients
treated with ThermoDox plus optimized RFA (RFA ≥
45 minutes).
- "OPTIMA Phase III Clinical Trial: Study Design and
Protocols," by Riccardo
Lencioni, MD, FSIR, EBIR, Professor and Director of
Diagnostic Imaging and Intervention at Pisa University School of
Medicine in Pisa, Italy, Lead
European Principal Investigator for Celsion's HEAT Study and member
of the ILCA Governing Board. Dr. Lencioni reviewed the latest
findings from the HEAT Study post-hoc analysis, which strongly
supports the rationale for a minimum 45 minute ablation time when
using ThermoDox® and suggests that there could be an important
curative role for optimized RFA and ThermoDox® in intermediate HCC.
Celsion is currently evaluating ThermoDox® plus optimized RFA in
its ongoing Phase III OPTIMA Study, currently enrolling patients in
over 75 clinical sites globally.
"Results from the HEAT Study, one of the largest clinical trials
ever conducted in primary liver cancer, reinforce the potential for
ThermoDox® in combination with an optimized RFA regimen as a
curative treatment for this deadly cancer," said Professor
Lencioni. "With median overall survival of more than 6.5
years, or 79 months, data from the HEAT Study post-hoc analysis
suggest a greater than two year median survival advantage for
treatment with ThermoDox® plus optimized RFA, a meaningful finding
given that few treatments are effective in prolonging survival in
HCC."
As of July 15, 2015, data from the
latest HEAT Study post-hoc overall survival 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
overall survival compared to optimized RFA alone. The Hazard Ratio
(HR) at this analysis was 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 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).
The presentations are available on Celsion's website at
http://investor.celsion.com/events.cfm.
About The International Liver Cancer Association
The International Liver Cancer Association (ILCA) is the only
international organization devoted exclusively to liver cancer
research for experts from all related disciplines – medical,
interventional and surgical oncology as well as hepatology.
ILCA aspires to advance research in the pathogenesis, prevention
and treatment of liver cancer.
About Celsion's Phase III OPTIMA Study
Celsion's Phase III OPTIMA Study is a global pivotal,
double-blind, placebo-controlled study evaluating ThermoDox®, its
proprietary heat-activated liposomal encapsulation of doxorubicin,
in combination with optimized radiofrequency ablation (RFA) in HCC.
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
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; 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 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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SOURCE Celsion Corporation