Principal Investigator Professor Riccardo Lencioni Presents Celsion ThermoDox® Trial Data at SPECTRUM 2020 Interventional On...
05 February 2020 - 12:30AM
Celsion Corporation (NASDAQ:
CLSN), an oncology drug-development company, announces
that Prof. Riccardo Lencioni, M.D., FSIR, EBIR delivered a
presentation titled “Thermally-Sensitive Ablation Enhancers: Where
Do We Stand?” at the SPECTRUM 2020 Interventional Oncology
Conference held in Miami , FLA last month. Dr. Lencioni is a
professor in the Department of Radiology at the University of Pisa
School of Medicine in Italy and is an Honorary Research Professor
of Interventional Oncology at the Miami Cancer Institute. He was
the lead principal investigator in Europe for the Company’s
completed Phase III HEAT Study in hepatocellular carcinoma (HCC),
or primary liver cancer, using radiofrequency ablation (RFA) plus
ThermoDox®, the Company’s lead product.
The SPECTRUM Conference is the only
interventional oncology conference endorsed by The American Society
of Clinical Oncology (ASCO). In his talk, Prof. Lencioni focused on
the HEAT Study subgroup analysis showing the duration of RFA
heating time per tumor volume of 45 minutes or longer plus
ThermoDox® was key to overall survival benefit in this patient
population. He noted that in early-stage HCC, nearly 50% of
patients with a solitary lesion of less than 5 cm on imaging have
microsatellites on histology. While RFA and other energy sources
are not able to treat these microsatellites, a thermosensitive drug
carrier such as ThermoDox® would deposit increased amounts of
doxorubicin in the margins of a tumor given increased ablation
time.
“The significant attention ThermoDox® is
receiving among key opinion leaders at important medical
conferences has helped build awareness of our drug in combination
with RFA for treating HCC,” said Michael H. Tardugno, Celsion’s
chairman, president and chief executive officer. “We are grateful
to Prof. Lencioni for helping Celsion create the training video on
RFA heating time for lesion sizes from 3 cm to 7 cm that is being
used by all investigators in our current Phase III OPTIMA
Study.”
The Company’s OPTIMA Study was based on the
prospective analysis of the HEAT Study subgroup of patients who
received 45 minutes or more of RFA energy. The OPTIMA Study was
fully enrolled in August 2018 with 556 subjects from 65 clinical
sites in 14 countries. At its first interim analysis in November
2019 following 128 patient events, or deaths, the independent Data
Monitoring Committee (iDMC) unanimously recommended the OPTIMA
Study continue according to protocol based on safety and data
integrity.
The Company re-affirms its projection that its
second pre-planned interim efficacy analysis will occur during the
second quarter of 2020, following 158 patient events, or deaths.
The hazard ratio for success at 158 events is 0.70, which is below
the hazard ratio of 0.65 observed for the 285 patients in the HEAT
Study subgroup of patients treated with RFA of 45 minutes or
longer.
Mr. Tardugno added, “We were pleased that the
HCC part of the SPECTRUM program featured invited faculty with ties
to Celsion, such as Dr. Josep Llovet, Founder and Director of the
Liver Cancer Program and Full Professor of Medicine at the Mount
Sinai School of Medicine in New York, who is chair of the OPTIMA
iDMC, and Dr. Ghassan Abou-Alfa of Memorial Sloan Kettering Cancer
Center and Professor, Weill Medical College at Cornell University,
both in New York City, who was a member of the HEAT Study DMC. The
medical community’s independent assessment, along with the National
Institutes of Health’s published confirmation of the hypothesis
supporting the potential for ThermoDox as a curative treatment for
the largest unmet need in oncology is gratifying indeed.”
About SPECTRUM
The annual SPECTRUM conference offers attendees
a comprehensive review of a variety of oncological diseases,
combined with the latest developments in medical, interventional
and surgical therapeutic options across multiple disciplines. A
practical overview of how to incorporate emerging therapies into
practice is presented through a multidisciplinary lens, intended to
achieve the highest levels of success in the fight against
cancer.
About ThermoDox®
Celsion’s most advanced program is a
heat-mediated 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. ThermoDox® is positioned
for use with multiple heating technologies and has the potential to
treat a broad range of cancers including metastatic liver,
recurrent chest wall breast cancer and non-muscle invading bladder
cancers.
Celsion’s LTLD technology leverages two
mechanisms of tumor biology to deliver higher concentrations of
drug directly to the tumor site. In the first mechanism, 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, ThermoDox® is engineered with a
half-life to allow significant accumulation of liposomes at the
tumor site as these liposomes recirculate in the blood stream. In
the second mechanism, when an external heating device heats 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 can release a
chemotherapeutic agent directly into the tumor and 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
subject to tumor invasion, supporting more 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 development for other cancer indications. The
Company’s product pipeline also includes GEN-1, a DNA-based
immunotherapy for the localized treatment of ovarian cancer.
Celsion has two platform technologies for the development of novel
nucleic acid-based immunotherapies and other anti-cancer DNA or RNA
therapies.
Forward-looking Statements
Forward-looking statements in this news 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 or regulatory authorities; and
other risks detailed from time to time in the Celsion's periodic
filings 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. ChurchExecutive Vice President and
CFO609-482-2455 jchurch@celsion.com
Or
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
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