Data Monitoring Committee (DMC) Completes Planned Safety and Data Review of Celsion’s Phase III OPTIMA Study of ThermoDox®...
April 09 2018 - 8:30AM
Blinded Progression-Free Survival (PFS) Rate in the OPTIMA Study
is Consistent With the Subgroup Patient Population That Showed
Benefit in the HEAT Study
Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced that the independent Data
Monitoring Committee (DMC) for the Company's 550-patient,
multinational, double-blind, placebo-controlled, pivotal Phase III
clinical study of ThermoDox® in combination with radiofrequency
ablation (RFA) for primary liver cancer (the OPTIMA Study), has
unanimously recommended that the study continue according to
protocol to its data readout. The DMC’s recommendation was based on
the Committee’s assessment of safety and data integrity of the
first 75% of patients randomized in the trial as of February 5,
2018.
"The DMC’s latest recommendation to continue the
ongoing OPTIMA Study further supports our confidence in ThermoDox®
and the OPTIMA Study’s design to demonstrate the safety and
effectiveness of ThermoDox® plus standardized RFA therapy in the
treatment of patients with primary liver cancer,” said Nicholas
Borys, M.D., Celsion's senior vice president and chief medical
officer. “An important feature of the OPTIMA Study protocol is
investigators’ adherence to RFA heating time of greater than 45
minutes for tumors greater than three centimeters – a key
determination from the in-depth analyses of our previously
completed HEAT Study. Based on the DMC’s review of the 411 patients
enrolled in the OPTIMA Study as of February 5, 2018, it concluded
that the integrity of the study is intact and that ThermoDox® is
safe for continued enrollment of newly diagnosed,
intermediate-stage patients. We note also that in the analysis of
blinded data from the intent-to-treat population, consolidated for
both arms, median progression free survival (PFS) was 20.8 months.
This compares favorably to the HEAT Study median PFS of 13.8 months
and is consistent with the hypothesis-generating estimates from the
HEAT Study manuscript published in the October 2017 issue of the
peer-reviewed medical journal, ‘Clinical Cancer Research.’”
The DMC consists of an independent group of
medical and scientific experts responsible for reviewing and
evaluating patient safety and efficacy data for the company's Phase
III OPTIMA Study. The DMC reviews study data at regular intervals
in order to ensure the safety of all patients enrolled in the trial
and to monitor the quality and overall conduct of the trial,
including each site’s compliance with the minimum RFA heating time
of 45 minutes, which is specified in the study protocol.
The OPTIMA Study's design and statistical plan
incorporates two pre-planned interim efficacy analyses by the DMC
with the intent of evaluating safety, efficacy and futility to
determine if there is overwhelming evidence of clinical benefit or
a low probability of treatment success to continue, modify or
terminate the study.
“This DMC analysis was the last planned interim
analysis prior to enrollment completion in the OPTIMA Study, and it
represents another important milestone in our ThermoDox®
development program,” said Michael H. Tardugno, Celsion's chairman,
president and chief executive officer. “With the recent addition of
five new sites in China and Vietnam, we are rapidly approaching
enrollment completion, which is currently at 80% of the 550-patient
total necessary to statistically validate the Overall Survival
primary endpoint. We expect to complete enrollment in the third
quarter of 2018. Data from the first interim efficacy results from
this important study may be available early in the second quarter
of 2019.”
Hepatocellular Carcinoma (HCC) Symposium
at International Liver Congress 2018 on April 12, 2018
Celsion also announced today that it will be
sponsoring a symposium titled, “Emerging Horizons in HCC: From
Palliation to Cure,” on April 12, 2018, at the International Liver
Congress™ 2018, in Paris, France. The symposium will discuss the
current treatment paradigm and new developments in treating
intermediate-size HCC, including the role of tyrosine kinase
inhibitors (TKIs) and immuno-oncology. The symposium will be led 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.
The slides from Prof. Lencioni’s presentation,
“Rethinking Our Approach to Intermediate-Size HCC,” will be
available on Celsion’s corporate website at www.celsion.com
following the symposium on April 12, 2018.
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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