Celsion Corporation Announces Positive DSMB Review of Phase 1b OVATION Study in Ovarian Cancer
15 September 2016 - 10:00PM
Celsion Corporation (NASDAQ:CLSN) today announced that the
independent Data Safety Monitoring Board (DSMB) has completed its
safety review of data from the first three patient cohorts in the
ongoing Phase Ib OVATION Study. Based on the DSMB’s
recommendation, the study will continue as planned and the Company
will proceed with dosing in its fourth and final patient cohort at
an escalated dose. 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.
“The DSMB’s recommendation and the lack of any
dose limiting toxicities in the trial to date underscore the
improved tolerability of GEN-1 over recombinant IL-12 protein-based
therapies,” said Nicholas Borys, M.D., senior vice president and
chief medical officer of Celsion. “The favorable safety profile we
have seen thus far is consistent with the translational data that
we reported earlier this year, which show that GEN-1 produces a
sustained, localized secretion of IL-12 protein and avoids the high
levels of systemic exposure which have limited the development of
recombinant IL-12 therapies in the past.”
“We could not be more excited to progress with
the OVATION Study and look forward to reporting clinical findings
from the third patient cohort, as well as translational data from
the first two cohorts, early in the fourth quarter.
Furthermore, we expect to report final data from this highly
promising study in the first quarter of 2017,” said Michael H.
Tardugno, Celsion's chairman, CEO and president. “We have been
encouraged, as have been our Investigators, by the findings to-date
in this difficult-to-treat patient population. As we have
previously reported, all six patients in the first two cohorts
experienced a clinically meaningful response, ranging from stable
disease to one pathologically confirmed complete response. 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.”
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.
Future studies of GEN-1 will include a Phase I/II study combining
GEN-1 with Avastin® and Doxil®.
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 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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