LAWRENCEVILLE, N.J.,
Nov. 2, 2015 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced the presentation of data from
the Company's HEAT Study, highlighting the curative potential for
ThermoDox® plus optimized radiofrequency ablation (RFA) in
intermediate primary liver cancer, also known as hepatocellular
carcinoma (HCC), as well as preclinical data on the correlation of
heating duration during RFA in combination with ThermoDox. The
clinical data were presented 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, on
October 30-31, 2015 at the 2015 Asian
Conference on Tumor Ablation (ACTA) in Fukuoka, Japan.
"There is clear evidence that the duration of the RFA regimen is
critical when treating patients with ThermoDox," said Professor
Tak, lead investigator in South
Korea for the Company's HEAT and OPTIMA studies. "Findings
from the data presented at ACTA, including the multivariate
analysis, HEAT Study data demonstrating compelling survival
outcomes and supportive preclinical data, underscore the importance
of Celsion's ongoing OPTIMA Study, which is designed to demonstrate
the potential of ThermoDox with an optimized RFA regimen in this
setting."
"The incidence rate of HCC within Asian countries is growing at
an alarming rate, with current estimates projecting that
Asia will account for
approximately 75% of newly diagnosed cases annually," said
Professor Lin, lead investigator in Taiwan for the Company's HEAT and OPTIMA
studies. "The totality of the data presented demonstrate that
ThermoDox plus optimized RFA has a strong potential to serve as a
curative therapy for patients with liver cancer, where there exists
a strong unmet need for effective treatment options."
The three presentations included:
- "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 discussed
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 reviewed 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 reviewed 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 presentation abstracts 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, including timing,
enrollment and data; 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
860-483-1721
Director, Communications
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation