LAWRENCEVILLE, N.J.,
Oct. 6, 2015 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN), an oncology drug development company,
today announced the upcoming presentations of data supporting the
Company's ongoing pivotal phase III OPTIMA Study of ThermoDox®, its
proprietary heat-activated liposomal encapsulation of doxorubicin
in combination with optimized radiofrequency ablation (RFA) for the
treatment of intermediate primary liver cancer. The data will
be presented on October 30-31, 2015
at the 2015 Asian Conference on Tumor Ablation (ACTA) in
Fukuoka, Japan by two leading
liver cancer experts from South
Korea and Taiwan, Professor
Won Young Tak, MD, Ph.D., Division of Gastroenterology and
Hepatology, Department of Internal Medicine, School of Medicine,
Kyungpook National University, Daegu,
Republic of Korea and Dr. Shi-Ming
Lin, MD, co-chair ACTA 2015 and vice chairman, Department of
Gastroenterology and Hepatology, Chang
Gung Memorial Hospital, Taipei, Taiwan. Professor Tak's
presentation will highlight ThermoDox® in an oral presentation
during the Plenary Lecture Session: "Top Tips for the Liver
Tumor Ablation".
"Data underscoring the value of ThermoDox® in combination with
RFA therapy as a potentially curative treatment for primary liver
cancer, a disease with limited treatment options, will be presented
once again at an internationally recognized medical
conference. ILCA, WCIO, ECIO, ASCO, and now ACTA have each
provided a forum for liver cancer thought leaders to discuss the
promise of ThermoDox® with leading physicians and scientists from
the global oncology community. Medical, surgical and
interventional oncologists from N. America, Asia, and Europe have endorsed our pivotal phase III
OPTIMA Study, now ongoing in 11 counties worldwide," said
Michael H. Tardugno, Celsion's
chairman, president and chief executive officer. "It is a privilege
to now have Professor Tak along with Dr. Lin, two
internationally recognized liver cancer experts who have
comprehensive experience with ThermoDox® as a result of their deep
involvement in Celsion's HEAT Study, present these findings."
The three presentations include:
- "Effect of Radiofrequency Ablation (RFA) Dwell Time (+/-)
ThermoDox on Safety and Overall Survival (OS) Among 452
Intermediate Solitary HCC Patients With Lesions 3 to 7 cm: HEAT
Study Data," by Professor Won Young Tak, MD, Ph.D.,
Division of Gastroenterology and Hepatology, Department of Internal
Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea and
lead investigator in South Korea
for the Company's HEAT and OPTIMA studies. Professor
Tak will discuss data from Celsion's latest HEAT Study post-hoc
analysis, which suggests an overall survival benefit of over two
years in the large subgroup of patients treated with ThermoDox plus
optimized RFA (RFA > 45 minutes).
- "Effect of Standardizing Radiofrequency Ablation and
Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox®) on
Overall Survival (OS) Among Patients with a Solitary 3 to 7 cm HCC
Lesion: A HEAT Study Multivariate Analysis," by Dr.
Shi-Ming Lin, MD, co-chair ACTA
2015, vice-chairman, Department of Gastroenterology and Hepatology,
Chang Gung Memorial Hospital,
Taipei, Taiwan, and lead
investigator in Taiwan for the
Company's HEAT and OPTIMA studies. Dr. Lin will review the
extensive data from Celsion's HEAT Study, including the results of
multivariate analyses performed which clearly suggests that RFA
heating or dwell time greater than 45 minutes was the only
statistically significant variable that explained the significant
improvement in overall survival (79 months in the optimized RFA
plus ThermoDox® subgroup versus 53.6 months in the optimized RFA
only subgroup) in a large, well bounded subgroup of 285 patients
(41% of the HEAT Study patients).
- "Importance of Heating Time on the Local Drug Deposition
During RFA in Combination with Lyso-Thermosensitive Liposomal
Doxorubicin (LTLD) in a Porcine Model," by
Nicholas Borys, MD, Celsion's senior
vice president and chief medical officer. Dr. Borys will
review findings from a preclinical study demonstrating that in a
porcine model, a direct correlation was observed between the
duration of RFA heating, or dwell time, and the concentration of
doxorubicin localized to the liver.
The presentations will be available on Celsion's website at
http://investor.celsion.com/events.cfm.
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
860-483-1721
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation