Celsion Corporation to Hold Third Quarter 2019 Financial Results Conference Call on Friday, November 15, 2019
November 08 2019 - 8:30AM
Celsion Corporation (NASDAQ: CLSN) announced today that the Company
will host a conference call to discuss financial results for the
quarter ended September 30, 2019 and provide an update on its
development programs for ThermoDox®, its proprietary heat-activated
liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA
plasmid vector formulated into a nanoparticle with a non-viral
delivery system at 11:00 a.m. EST on Friday, November 15, 2019.
- On November 4, 2019 the Company
announced that the independent Data Monitoring Committee (iDMC)
unanimously recommended the OPTIMA Study continue according to
protocol. The recommendation was based on a review of blinded
safety and data integrity from 556 patients enrolled in the
Company’s multinational, double-blind, placebo-controlled pivotal
Phase III study with ThermoDox® plus RFA in patients with HCC.
The iDMC’s pre-planned interim efficacy review followed 128
patient events, or deaths, which occurred in August 2019. Data
presented demonstrated that progression-free survival (PFS) and
overall survival (OS) data appear to be tracking with patient data
observed at a similar point in the Company’s 285 patient,
well-balanced subgroup of patients followed prospectively in the
earlier Phase III study (the Prospective Subgroup) upon which the
OPTIMA Study is based. This Prospective Subgroup demonstrated a
2-year overall survival advantage and a median time to death of
more than 7 ½ years.
From the data review, the Company believes that
the OPTIMA Study is well positioned for success at the next
pre-planned interim efficacy analysis, which is intended after a
minimum of 158 patient deaths and is projected to occur during the
second quarter of 2020. The hazard ratio for success at 158 events
is 0.70. This is below the hazard ratio of 0.65 observed for
the 285 patients in the Prospective Subgroup of patients treated
with RFA > 45 minutes.
- On November 5, 2019, the Company
announced that the Data Safety Monitoring Board (DSMB) has
completed its safety review of data from the first eight patients
enrolled in the ongoing Phase I/II OVATION 2 Study. Based on
the DSMB's recommendation, the study will continue as planned and
the Company will proceed with completing enrollment in the Phase I
portion of the trial. The OVATION 2 Study is a Phase I/II
study designed with a single dose escalation phase to 100 mg/m² of
GEN-1 in the Phase I portion, followed by a continuation at the
selected dose in Phase II, in an open-label, 1:1 randomized
design. Developed with extensive input from the Company's
Medical Advisory Board, the OVATION 2 Study builds on promising
clinical and translational research data from the Phase IB
dose-escalation OVATION 1 Study in which enrolled patients received
escalating weekly doses of GEN-1 up to 79 mg/m² for a total of
eight treatments in combination with neoadjuvant chemotherapy
(NACT), followed by interval debulking surgery (IDS). In addition
to exploring a higher dose of GEN-1 in the OVATION 2 study,
patients will continue to receive GEN-1 after their IDS in
combination with adjuvant chemotherapy.
To participate in the call, interested parties
may dial 1-800-667-5617 (Toll-Free/North America) or 1-334-323-0501
(International/Toll) and ask for the Celsion Corporation Third
Quarter 2019 Earnings Call (Conference Code: 5419619) to register
ten minutes before the call is scheduled to begin. The call will
also be broadcast live on the internet at www.celsion.com.
The call will be archived for replay on Friday, November 15, 2019
and will remain available until November 29, 2019. The replay can
be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference
ID: 5419619. An audio replay of the call will also be
available on the Company's website, www.celsion.com, for 90 days
after 2:00 p.m. EST Friday, November 15, 2019.
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. For more information on Celsion, visit:
http://www.celsion.com. (CLSN-FIN).
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; 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.
Celsion Investor
Contact
LHA Investor
Relations
Jeffrey W.
Church
Kim Sutton Golodetz Executive Vice President & CFO
212-838-3777
609-482-2455
kgolodetz@lhai.com jchurch@celsion.com
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