Celsion Corporation (NASDAQ: CLSN), an oncology drug development
company, today announced a presentation and discussion of
ThermoDox®, its proprietary heat-activated liposomal encapsulation
of doxorubicin in Phase III development for the treatment of
primary liver cancer, and the evolving treatment landscape for
hepatocellular carcinoma (HCC), as part of a company-sponsored
symposium at the International Liver Congress™ 2018, in Paris,
France. The symposium titled, “Emerging Horizons in HCC: From
Palliation to Cure,” featured presentations by co-chairs and HCC
experts, Ghassan Abou-Alfa, M.D., a board-certified medical
oncologist at Memorial Sloan Kettering Cancer Center in New York
City, and Riccardo Lencioni, M.D., FSIR, EBIR, professor at the
University of Pisa School of Medicine.
Dr. Abou-Alfa’s presentation, “New Developments
in Targeted Therapies for HCC: The Mounting Wave of
Immuno-Oncology,” discussed recent developments in treating HCC,
including the role of tyrosine kinase inhibitors (TKIs),
immuno-oncology and CAR-T therapies, as well as advancements in
chemotherapy and combination treatment with local therapy.
“HCC is a devastating disease with a poor
prognosis, affecting an estimated 850,000 people globally,” said
Dr. Abou-Alfa. “Today, the five-year survival rate is less than
10%, and new, effective treatments that can change this statistic
by meaningfully improving overall survival in patients with HCC are
urgently needed. As a clinician, I am encouraged by recent
innovations, from TKIs, advances in chemotherapy and
immuno-oncology, to therapies like Celsion’s ThermoDox®, which have
potential to provide a true patient benefit in liver cancer, and I
look forward to seeing survival outcomes from ongoing studies.”
Prof. Lencioni’s presentation, “Rethinking Our
Approach to Intermediate-Size HCC” focused on the increasing
incidence and burden of HCC globally, the limited overall survival
benefit with current therapies at later stages of disease
progression, and the potential for ThermoDox® to provide enhanced
survival benefit with standardized radiofrequency ablation
(RFA).
“ThermoDox® is the first treatment candidate for
HCC designed for image-guided drug delivery to be tested in a
large, multicenter Phase III trial,” said Prof. Lencioni. “Post-hoc
analyses of the first Phase III study of ThermoDox® – the HEAT
Study – generated important findings that demonstrated its
potential to meaningfully increase overall survival when target
tissue is adequately heated with RFA for 45 minutes or longer.
These analyses showed that ThermoDox® treatment with prolonged RFA
heating can increase doxorubicin tissue concentration and could
extend overall survival to more than two years. The company’s
ongoing second Phase III study, the OPTIMA Study, is designed to
test this survival benefit hypothesis. If this hypothesis bears out
in the OPTIMA Study, this would be very meaningful and highly
encouraging as there are few available treatments effective in
prolonging survival in HCC.”
Celsion’s 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.
“HCC is a disease characterized by high
mortality and an increasing prevalence globally. Patients with
primary liver cancer are underserved by current treatments, and
Celsion is focused on raising awareness and advancing innovation in
treating HCC,” said Michael H. Tardugno, Celsion's chairman,
president and chief executive officer. “Our Phase III OPTIMA Study
for ThermoDox® continues to make steady progress, having now
reached over 80% enrollment. We look forward to completing
enrollment in the OPTIMA Study in the third quarter of 2018, with
first interim efficacy results projected early next year.”
The slides from Prof. Lencioni’s presentation,
“Rethinking Our Approach to Intermediate-Size HCC,” are available
on Celsion’s corporate website at www.celsion.com.
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 analyses 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.
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 press 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; U.S. Food and Drug Administration 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
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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