Celsion Corporation today announced that an abstract discussing the
Company’s Phase III HEAT study evaluating ThermoDox® in combination
with radiofrequency ablation (RFA) was one of six selected for
presentation as part of the lecture of the Presidential Selection
at the Korean Liver Cancer Association’s 12th Annual Scientific
Meeting in Seoul, South Korea. ThermoDox® is Celsion’s proprietary,
heat-activated liposomal encapsulation of doxorubicin for the
treatment of primary liver cancer, also known as hepatocellular
carcinoma, or HCC. The presentation was given on February 9, 2018,
by Won Young Tak, M.D., Ph.D., Professor Internal Medicine,
Gastroenterology & Hepatology, Kyungpook National University
Hospital Daegu, Republic of Korea, and a lead investigator for the
HEAT Study and the Company’s ongoing second Phase III study of
ThermoDox® in combination with RFA, the OPTIMA Study.
“RFA duration appears to be a critically
important factor in treating patients with ThermoDox®,” said Dr.
Tak. “Findings from the HEAT Study suggest that ThermoDox® plus
standardized RFA has the potential to significantly prolong the
survival of, and perhaps cure, patients with liver cancer. This is
a disease state with a high mortality rate and an urgent need for
treatment options that can meaningfully improve patient survival.
Interest in the HEAT Study and the potential for improved outcomes
with ThermoDox® plus standardized RAF remains of great interest to
the treatment community, as evidenced by the academic committee’s
selection. Validation of this approach would represent a meaningful
advance for this potential new treatment option, and the ongoing
OPTIMA Study, if successful, would represent a significant step
forward toward providing a potential new treatment for patients
with HCC.” The abstract titled, “Phase III HEAT Study
Adding Lyso-Thermosensitive Liposomal Doxorubicin to Radiofrequency
Ablation in Patients with Unresectable Hepatocellular Carcinoma
Lesions,” and Dr. Tak’s discussion, detailed learnings from the
Company’s 701-patient HEAT Study and included results from
simulation studies and findings from the post hoc subgroup
analysis. Dr. Tak noted that key findings from the study and
analyses of ThermoDox® plus RFA suggested that the therapeutic
effect of ThermoDox® plus RFA may be improved when the RFA dwell
time for solitary lesions is greater than or equal to 45 minutes.
The HEAT study and post-hoc analyses are published in the October
2017 issue of Clinical Cancer Research,
at: http://clincancerres.aacrjournals.org/content/early/2017/10/10/1078-0432.CCR-16-2433.long.
Developed in consultation with leading primary
liver cancer researchers, and statistical and regulatory experts,
Celsion is conducting the Phase III OPTIMA Study, a global,
pivotal, double-blind, placebo-controlled clinical trial (Clinical
Trials.gov NCT021126560) to evaluate the safety and efficacy of
ThermoDox® in combination with RFA standardized to a minimum of 45
minutes across all investigators and sites for treating lesions 3
to 7 centimeters, versus standardized RFA alone. Enrollment in the
OPTIMA Study at year-end 2017 reached 74% of the 550 patients
necessary to ensure that its primary endpoint, overall survival,
can be evaluated with statistical significance. The statistical
plan for the OPTIMA Study calls for two interim efficacy analyses
by the independent Data Monitoring Committee. The Company currently
expects enrollment completion during the third quarter of 2018 and
the first pre-planned efficacy analysis in the first half of
2019.
Upcoming Symposium at International
Liver Congress 2018
Celsion also today announced that it will be
sponsoring an HCC symposium on April 12, 2018, at the International
Liver Congress™ 2018, in Paris, France. The International
Liver Congress is an annual conference put on by EASL (The European
Association for the Study of the Liver). The conference is being
held from April 11-15 2018 in Paris. Participating in the symposium
are liver cancer experts, Riccardo Lencioni, M.D., FSIR, EBIR,
former professor at the University of Pisa School of Medicine and
Ghassan K Abou-Alfa, M.D., a board-certified medical oncologist,
specializing in primary liver cancer (hepatocellular carcinoma),
pancreas, gallbladder, and bile duct tumors, at Memorial
Sloan-Kettering Cancer Center. Additional details about the
symposium will be made available prior to the conference.
“With incidence and prevalence rates of 32 and
114 cases per 100,000, respectively, HCC is an enormous problem in
South Korea, the importance of which is reinforced by the Korean
Liver Association’s dedication to improving care for patients with
this life limiting disease. Selection of the HEAT Study’s findings
that ThermoDox®, combined with well controlled RFA, has the
potential to be curative and is being investigated in our current
OPTIMA Study, compliments the search for medical advances that the
South Korean medical community has been recognized for worldwide,”
said Michael H. Tardugno, Celsion’s chairman, chief executive
officer and president. “Similarly in Europe, the OPTIMA Study, and
the data supporting its “intent to cure” thesis, will be presented
and discussed by internationally recognized HCC experts, Dr.
Lencioni and Dr. Abou-Alfa. We look forward to advancing our
Phase III OPTIMA Study and a first look at data early next
year.”
About the OPTIMA Study
The Phase III OPTIMA Study is expected to enroll
up to 550 patients in up to 70 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 three to seven centimeters, versus optimized
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.
ThermoDox® has received U.S. FDA Fast Track
Designation and has been granted orphan drug designation for
primary liver cancer in both the U.S. and Europe. Further, the U.S.
FDA has provided ThermoDox® with a 505(b)(2) registration
pathway. Subject to a successful trial, the OPTIMA Study has
been designed to support registration in all key primary liver
cancer markets. Celsion fully expects to submit registrational
applications in the USA, Europe and China. The Company believes
that applications will be accepted in South Korea, Taiwan and
Vietnam, three other large and important markets for ThermoDox®
subject to approval in Europe, China or the USA.
About ThermoDox®
Celsion’s most advanced program is a
heat-mediated, tumor-targeting drug delivery technology that
employs a novel heat-sensitive liposome engineered to address a
range of difficult-to-treat cancers. The first application of this
platform is ThermoDox®, a lyso-thermosensitive liposomal
doxorubicin (LTLD), whose novel mechanism of action delivers high
concentrations of doxorubicin to a region targeted with the
application of localized heat at 40°C, just above body temperature.
In one of its most advanced applications, ThermoDox®, when combined
with radiofrequency thermal ablation (RFA), has the potential to
address a range of cancers. For example, RFA in combination with
ThermoDox® has been shown to expand the “treatment zone” with a
margin of highly concentrated chemotherapy when treating individual
primary liver cancer lesions. The goal of this application is to
significantly improve efficacy.
Celsion’s LTLD technology leverages two
mechanisms of tumor biology to deliver higher concentrations of
drug directly to the tumor site. The first: Rapidly growing
tumors have leaky vasculature, which is permeable to liposomes and
enables their accumulation within tumors. Leaky vasculature
influences a number of factors within the tumor, including the
access of therapeutic agents to tumor cells. Administered
intravenously, LTLD is engineered to allow significant accumulation
of liposomes at the tumor site at the time of radiofrequency
ablation as these liposomes recirculate in the blood stream.
The second: When the tumor tissue is heated to a temperature of
40°C or greater, the heat-sensitive liposome rapidly changes
structure and the liposomal membrane selectively dissolves,
creating openings that release the chemotherapeutic agent directly
into the tumor and into the surrounding vasculature. Drug
concentration increases as a function of the accumulation of
liposomes at the tumor site, but only where the heat is present.
This method targets only the tumor and the area related to tumor
invasion, supporting precise drug targeting.
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. For more information on Celsion, visit our
website: http://www.celsion.com. (CLSN-LTSL/ThermoDox® CLSN-Optima
Study/HCC)
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.
ThermoDox® is a registered trademark of Celsion
Corporation.
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
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