LAWRENCEVILLE, N.J.,
Sept. 8, 2014 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced highlights from three
presentations by three of the world's leading liver cancer experts
and principal investigators for the Company's pivotal Phase III
OPTIMA Study of ThermoDox®, Celsion's proprietary heat-activated
liposomal encapsulation of doxorubicin, in combination with
standardized radiofrequency ablation (sRFA) in primary liver
cancer, also known as hepatocellular carcinoma (HCC). The
symposium, highly attended by physicians committed to HCC research,
was conducted at the International Liver Cancer Association (ILCA)
7th Annual Conference from September 5 - 7, 2014 in Kyoto, Japan.
The presentations, covering new paradigms in staging HCC
patients, Phase III studies in HCC, and advances in image guided
radiofrequency ablation, were made on September 6, 2014, during Celsion's symposium on
current concepts for treating intermediate HCC. The symposium was
moderated by Professor Riccardo
Lencioni, MD, FSIR, EBIR, Executive Committee member of the
ILCA Governing Board.
The presentations were made by:
- Ronnie T.P. Poon, MD, MS, PhD,
FRCS (Edin), FACS, Professor of Surgery at the University of Hong Kong Queen Mary Hospital, Lead
Asia Pacific Principal Investigator for Celsion's Phase III OPTIMA
Study and member of the ILCA Governing Board.
Professor Poon's presentation, titled "New
Paradigms in Staging HCC: BCLC vs. Hong Kong Liver Cancer Staging
System (HKLS)," covered a more aggressive strategy for treating
different stages of HCC. Intermediate stage HCC may be curable with
RFA and combining sRFA with ThermoDox® may enhance the cure
rate.
- Richard S. Finn, MD, faculty at
the Division of Hermatology and Oncology and Director of the
Translational Oncology Research Laboratory at UCLA, North American Principal Investigator for
Celsion's Phase III OPTIMA Study and member of the ILCA Governing
Board.
Dr. Finn's presentation, titled "Phase III Studies in
Intermediate Stage HCC: What Have We Learned From Recent
Failures?" reviewed results from recent Phase III clinical
studies in intermediate stage HCC patients including recent overall
survival data from Celsion's Phase III HEAT Study post-hoc
analysis, noting a subgroup of significant size, strongly suggests
positive Overall Survival (OS) in ThermoDox® treated patients when
heating cycles from the radiofrequency ablation (RFA) procedure
were optimized.
As of June 30, 2014, data from the
latest HEAT Study post-hoc analysis continued to show that
ThermoDox® may significantly improve overall survival compared to a
RFA 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. For this group, clinical results
indicate a 57% improvement in Overall Survival, a Hazard Ratio of
0.639 (95% CI 0.419 – 0.974), and a p-value of 0.037.
- Riccardo Lencioni, MD, FSIR,
EBIR, Professor and Director of the Division of Diagnostic Imaging
and Intervention at Pisa University School of Medicine in
Pisa, Italy and Lead European
Principal Investigator for Celsion's Phase III OPTIMA Study.
Dr. Lencioni's presentation, titled "Image Guided Ablations:
Current Status and Future Prospects," reviewed findings from
the HEAT Study post-hoc analysis which strongly support the
rationale for a minimum 45 minute ablation time when using
ThermoDox®. The findings from the HEAT study suggest that
there could be an important curative role for RFA and ThermoDox® in
intermediate HCC if a 45 minute heating time is applied.
"Results from the HEAT Study, among the largest clinical trials
conducted in primary liver cancer, highlight the important
potential of ThermoDox® in this indication and underscores the need
to standardize RFA with ThermoDox®," said Professor Lencioni.
"The HEAT Study clearly demonstrated that there is a place for RFA
in treating intermediate HCC and standardizing RFA with ThermoDox®,
as in Celsion's OPTIMA Study, may be the key to a curative
treatment for this deadly cancer."
The three 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 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's Executive Committee consists of Dr. Peter R. Galle, Professor Riccardo Lencioni and Dr. Morris Sherman. Celsion noted that Professor
Lencioni and Poon and Dr. Sherman and Finn are participating in the
Company's Phase III OPTIMA Study.
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 radiofrequency ablation (RFA) in HCC. The study
is expected to enroll 550 patients globally, with up to 100 sites
in the United States, Europe, China
and Asia Pacific.
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.
The pipeline also includes EGEN-001, 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
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
SOURCE Celsion Corporation