Celsion Corporation (NASDAQ:CLSN) today announced that its
ongoing Phase III OPTIMA trial evaluating ThermoDox® in primary
liver cancer, also known as hepatocellular carcinoma or HCC, was
featured during an oral presentation at the 7th Asia-Pacific
Primary Liver Cancer Expert (APPLE) Meeting. ThermoDox® is
the Company’s proprietary heat-activated liposomal encapsulation of
doxorubicin, for the treatment of HCC.
Soo-Young Park, M.D., Associate Professor,
Kyungpook National University, School of Medicine Division of
Gastroenterology and Hepatology, delivered the presentation,
titled, “Radiofrequency Ablation +/- Lyso-Thermosensitive Liposomal
Doxorubicin (LTLD) in Intermediate-Size Hepatocellular Carcinoma:
The Ongoing Phase III OPTIMA Study.” The OPTIMA Study is an
ongoing global, pivotal, double-blind, placebo-controlled clinical
trial evaluating ThermoDox® in combination with Radio Frequency
Ablation (RFA) standardized to a minimum of 45 minutes across all
investigators and sites for treating lesions 3 to 7 centimeters,
versus standardized RFA alone. The study was developed in
consultation with leading primary liver cancer, statistical and
regulatory experts, and is based on extensive analysis of prior
clinical and preclinical studies of ThermoDox® plus standardized
RFA.
“The OPTIMA study represents an important study
in the field of HCC, one of the most common and deadly cancers
worldwide,” said Dr. Park. “ThermoDox® plus standardized RFA has
the potential to significantly improve overall survival of newly
diagnosed patients, and I look forward to working with my
colleagues to further advance this trial.”
“Data from the earlier HEAT Study suggest that
not only does this approach potentially prolong survival, but may
also serve as a curative treatment for HCC,” stated Won Young Tak,
M.D., Professor, Kyungpook National University, School of
Medicine, Division of Gastroenterology and Hepatology. “If
positive, this study could potentially establish ThermoDox® plus
standardized RFA as a first-line treatment for HCC.”
In July 2015, Celsion reported the latest
overall survival (OS) analysis of the HEAT Study post
hoc subgroup. The OS analysis demonstrated that in a
large, well bounded, subgroup of patients (n=285 patients, 41% of
the previous 701 patient HEAT Study), treatment with a combination
of ThermoDox® and standardized RFA (defined as RFA standardized to
a minimum of 45 minutes or sRFA > 45 min) provided an
average 58% improvement in OS compared to standardized RFA alone.
The Hazard Ratio (HR) at this analysis was 0.63 (95% CI 0.43 -
0.93), with a p-value of 0.0198. In this large subgroup,
median OS for the ThermoDox® plus standardized RFA group translates
into a 25.4 month (more than 2.1 year) survival benefit over the
standardized RFA only group - totaling approximately 80 months
(6-1/2 years, which is considered a curative treatment for HCC) for
the ThermoDox® plus standardized RFA group versus 53.6 months for
the standardized RFA only group.
"The strength of the preclinical and clinical
data to date reinforces our confidence in the potential of
ThermoDox in HCC and for a successful trial outcome,” stated
Michael H. Tardugno, Celsion's chairman, president and
chief executive officer. “We are extremely encouraged with
the investigators’ interest and enthusiasm for our approach. With
the trial enrolling patients in 13 countries, and in 9 of up to 20
sites in the Peoples Republic of China, we remain focused on the
efficient execution of the only active Phase III study in newly
diagnosed HCC patients.”
The OPTIMA Study
OPTIMA, a pivotal, double-blind,
placebo-controlled Phase III clinical trial, is expected to enroll
up to 550 patients at up to 75 sites in the North
America, Europe, China and Asia
Pacific. As of June 2016, the study has been successfully
enrolling patients at more than 50 clinical sites in 13 different
countries in North America, Europe and Asia
Pacific. In December 2015, Celsion announced that it
had received a Clinical Trial Application (CTA) approval from
the China Food and Drug Administration (CFDA) to conduct
the OPTIMA Study at up to 20 additional clinical sites
in China, the country where approximately 50% of the 850,000
new cases of primary liver cancer are diagnosed each year and where
the Company aims to enroll more than 200 patients in
the China territory, the minimum number required by the
CFDA to file a New Drug Application (NDA), assuming positive
clinical results.
The primary endpoint for the OPTIMA Study is
overall survival (OS). The statistical plan calls for two interim
efficacy analyses by an independent Data Monitoring Committee
(iDMC). The design of the OPTIMA Study is supported by the
retrospective analysis of a large subgroup of 285 patients in the
Company's previous 701 patient HEAT Study in primary liver cancer.
The study is also designed to establish a clear path to approval in
major liver cancer markets worldwide, with results from the OPTIMA
Study, if successful, providing the basis for a global registration
filing and marketing approval.
About LTLD (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, LTLD, 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 with a half-life to allow
significant accumulation of liposomes at the tumor site as these
liposomes recirculate in the blood stream. The second: When
an external heating device heats the tumor tissue 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 damages 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 anticancer DNA or RNA
therapies, including TheraPlas™ and TheraSilence™. For more
information on Celsion, visit our
website: http://www.celsion.com. (CLSN-TD CLSN-HS CLSN-OS)
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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