Celsion Corporation Announces Positive DSMB Review of Phase 1b OVATION Study in Ovarian Cancer
December 01 2016 - 8:00AM
Celsion Corporation (NASDAQ:CLSN) today announced that the
independent Data Safety Monitoring Board (DSMB) has completed its
safety review of data from the first four patient cohorts in the
ongoing Phase 1b OVATION Study. Based on the DSMB’s
recommendation, the study will continue as planned and the Company
will proceed with completing dosing in the fourth and final patient
cohort, which is currently enrolling patients. The OVATION
Study is a dose-escalating clinical trial combining GEN-1, the
Company's DNA-based immunotherapy, with the standard of care for
the treatment of newly-diagnosed patients with advanced ovarian
cancer who will undergo neoadjuvant chemotherapy followed by
interval debulking surgery.
“We are very encouraged by the data reported to
date. In the first three cohorts, we saw remarkable and
consistent responses across a number of clinically meaningful
measures, underscoring the potential promise of our immunotherapy
approach in this difficult-to-treat patient population,” said
Michael H. Tardugno, Celsion's chairman, CEO and president. “The
OVATION Study continues to progress on schedule and we look forward
to reporting additional clinical findings from the fourth patient
cohort, as well as translational data, later this month.
Furthermore, we expect to report final data from this study in the
first quarter of 2017.”
“Our OVATION Study is achieving its objective of
demonstrating that GEN-1 can be safely administered directly into
the peritoneum and is well tolerated by patients when combined with
standard neoadjuvant chemotherapy,” said Nicholas Borys, M.D.,
senior vice president and chief medical officer of Celsion.
“As we have previously reported, all nine patients in the first
three cohorts experienced a clinically meaningful response, ranging
from stable disease to one pathologically confirmed complete
response. Two-thirds of patients treated in the trial experienced
at objective tumor response. We also observed three cases of
no visible residual disease at time of surgery (R0
resection). In addition, we saw sustained decreases of 90% or
greater of the prospective indicator of the presence of ovarian
cancer cells, CA-125 protein, in all patients, as well as highly
impressive pathologically responses, which is associated with
prolonged survival. We hope to build on these impressive results
with our translational data, which will provide further insights on
the impact of localized IL-12 production with GEN-1.”
The OVATION Study is designed to enroll three to
six patients per dose cohort at escalating doses of GEN-1 with the
goal to identify a safe, tolerable and therapeutically active dose
of GEN-1 by recruiting and maximizing an immune response. The first
three cohorts each enrolled three patients. Enrollment in the
fourth and final cohort is underway, and Celsion expects to report
full data from the OVATION Study by the first quarter of 2017.
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. (TheraPlas/GEN-1, Ovation
Study/Ovarian Cancer)
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 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 (NASDAQ:CLSN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Apr 2023 to Apr 2024