Celsion Announces Highly Encouraging Initial Clinical Results from the Phase I Portion of the Phase I/II OVATION 2 Study with...
March 19 2020 - 8:00AM
Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced highly encouraging initial
clinical data from the first 15 patients enrolled in the ongoing
Phase I/II OVATION 2 Study for patients newly diagnosed with Stage
III and IV ovarian cancer. The OVATION 2 Study combines GEN-1, the
Company's IL-12 gene-mediated immunotherapy, with standard-of-care
neoadjuvant chemotherapy (NACT). Following NACT, patients undergo
interval debulking surgery (IDS), followed by three additional
cycles of chemotherapy.
GEN-1 plus standard NACT produced positive
dose-dependent efficacy results, with no dose-limiting toxicities,
which correlates well with successful surgical outcomes as
summarized below:
- Of the 15 patients treated in the
Phase I portion of the OVATION 2 Study, nine patients were treated
with GEN-1 at a dose of 100 mg/m² plus NACT and six patients were
treated with NACT only. All 15 patients had successful resections
of their tumors, with seven out of nine patients (78%) in the GEN-1
treatment arm having an R0 resection, which indicates a
microscopically margin-negative resection in which no gross or
microscopic tumor remains in the tumor bed. Only three out of six
patients (50%) in the NACT only treatment arm had a R0
resection.
- When combining these results with
the surgical resection rates observed in the Company’s prior Phase
Ib dose-escalation trial (the OVATION 1 Study), a population of
patients with inclusion criteria identical to the OVATION 2 Study,
the data reflect the strong dose-dependent efficacy of adding GEN-1
to the current standard of care NACT:
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% of Patients with |
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R0 Resections |
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0, 36, 47 mg/m² of GEN-1 plus NACT |
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n=12 |
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42% |
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61, 79, 100 mg/m² of GEN-1 plus NACT |
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n=17 |
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82% |
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- The objective response rate (ORR)
as measured by Response Evaluation Criteria in Solid Tumors
(RECIST) criteria for the 0, 36, 47 mg/m² dose GEN-1 patients were
comparable, as expected, to the higher (61, 79, 100 mg/m²) dose
GEN-1 patients, with both groups demonstrating an approximate 80%
ORR.
As previously reported, the independent Data
Safety Monitoring Board (DSMB) for the OVATION 2 Study completed
its initial safety review of data from the first 15 patients
treated with the first four weekly doses of GEN-1 at 100 mg/m², and
confirmed that there were no apparent dose-limiting toxicities in
any of the six evaluable patients (those patients who received at
least four weekly doses of GEN-1) and that intraperitoneal
administration of GEN-1 is well tolerated even when given with
standard NACT.
The OVATION 2 Study is an open-label,
130-patient, 1-to-1 randomized Phase I/II trial, 80% powered to
show the equivalent of a 33% improvement in progression-free
survival (PFS), the primary endpoint, when comparing the treatment
arm (NACT + GEN-1) with the control arm (NACT alone). GEN-1 is a
formulation of Celsion's proprietary, synthetic, non-viral cell
transfection platform TheraPlas, which incorporates DNA plasmids
coded for the inflammatory protein interleukin-12 (IL-12). Cell
transfection is followed by persistent, local secretion of the
IL-12 protein at therapeutic levels.
The OVATION 2 Study builds on encouraging
clinical and translational research data from the Phase Ib 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 NACT, followed by IDS. These data from the OVATION
1 Study were presented at the ASCO-SITC Clinical-Oncology Symposium
by Dr. Premal H. Thaker on May 4, 2019 and can be reviewed here. 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.
“Of the nine patients treated with GEN-1 at 100
mg/m² plus NACT in the Phase I portion of the OVATION 2 Study,
seven patients had an R0 resection at the time of their interval
debulking surgery. A recent article published in the European
Journal of Obstetrics & Gynecology and Reproductive Biology1
confirms the importance of complete tumor resection to improved
survival outcome,” said Nicholas Borys, M.D., executive vice
president and chief medical officer of Celsion. "The combined data
from our previous Phase Ib dose-escalating trial (OVATION 1 Study)
plus this latest data from the Phase I portion of the OVATION 2
Study further confirms the encouraging dose-dependent efficacy of
GEN-1 plus NACT. The clinical data at the three highest doses of
GEN-1 showed an 82% R0 resection rate, compared with a 50% R0
resection rate for the NACT only control arm of the OVATION 2
Study. Historical levels of R0 resections after interval debulking
surgery range from 40% to 60%."
1 219 (2017) 100-105
“These data provide an early, but highly
encouraging trend in both Phase I studies, and even more so when
the study populations are combined to provide a larger ‘n’,” stated
Michael H. Tardugno, Celsion’s chairman, president and chief
executive officer. “Confirmation that the 100 mg/m² dose is
effective as a treatment for newly diagnosed ovarian cancer will be
determined in the Phase II portion of the OVATION 2 Study, which is
expected to begin enrollment in the 2nd half of 2020. As an open
label randomized trial, we expect to report patient data and trends
over the course of 2021, as it becomes available, with final PFS
data expected to be reported 12 months following full patient
enrollment.”
About GEN-1 Immunotherapy
GEN-1, designed using Celsion's proprietary
TheraPlas platform technology, is an IL-12 DNA plasmid vector
encased in a nanoparticle delivery system, which enables cell
transfection followed by persistent, local secretion of the IL-12
protein. IL-12 is one of the most active cytokines for the
induction of potent anti-cancer immunity acting through the
induction of T-lymphocyte and natural killer (NK) cell
proliferation. The Company has previously reported positive safety
and encouraging Phase I results with GEN-1 given as monotherapy in
patients with peritoneally metastasized ovarian cancer, and
recently completed a Phase Ib trial of GEN-1 in combination with
PEGylated doxorubicin in patients with platinum-resistant ovarian
cancer.
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. The 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 our website:
http://www.celsion.com. (CLSN-G1 CLSN-OV)
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 |
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LHA Investor
Relations |
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Jeffrey W. Church |
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Kim Sutton Golodetz |
Executive Vice President, CFO and
Corporate Secretary |
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Senior Vice President |
609-482-2455 |
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212-838-3777 |
jchurch@celsion.com |
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kgolodetz@lhai.com |
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