Celsion Announces DSMB Recommendation to Continue GEN-1 at 100mg/m² Dose to Complete the Phase I Portion of OVATION 2 Study ...
06 November 2019 - 12:00AM
Celsion Corporation (NASDAQ: CLSN) today announced that the
independent Data Safety Monitoring Board (DSMB) has completed its
safety review of data from the first 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 combines GEN-1, the Company's IL-12
gene-mediated immunotherapy, with the standard of care for the
treatment of newly diagnosed patients with Stage III and IV ovarian
cancer who will undergo standard neoadjuvant chemotherapy (NACT)
followed by interval debulking surgery (IDS).
The OVATION 2 Study is a randomized Phase I/II
study designed to evaluate the safety of 100 mg/m² of GEN-1 in the
Phase I portion, followed by a continuation at the safe dose in the
Phase II portion in an open-label, 1:1 randomized design. GEN-1,
designed using Celsion's proprietary TheraPlas platform technology,
is an interleukin-12 (IL-12) DNA plasmid vector encased in a
non-viral nanoparticle delivery system, which enables cell
transfection followed by persistent, local secretion of the IL-12
protein.
In the OVATION 2 Study, patients in the GEN-1
treatment arm will receive GEN-1 plus chemotherapy pre- and
post-interval debulking surgery. The OVATION 2 Study will enroll up
to 130 patients with Stage III/IV ovarian cancer, with 12 to 15
patients in the Phase I portion and up to 118 patients in the Phase
II portion. The study is powered to show a 33% improvement in
progression-free survival (PFS), the primary endpoint, when
comparing GEN-1 with NACT versus NACT alone. The PFS primary
analysis will be conducted after at least 80 events (or deaths)
have been observed, or after all patients have been followed for at
least 16 months, whichever is later.
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 I 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. 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.
"This latest DSMB review of GEN-1 at 100 mg/m²
confirmed that there were no dose limiting toxicities detected in
any of the five patients dosed with GEN-1 and that intraperitoneal
administration is well tolerated even when given with standard
NACT," said Nicholas Borys, M.D., executive vice president and
chief medical officer of Celsion. “Of the eight patients treated in
the Phase I portion of the OVATION 2 Study, five patients were
treated with GEN-1 plus NACT and three patients were treated with
NACT only. We look forward to presenting surgical results, overall
response rates, and translational data as it becomes available
later this quarter.”
Dr. Borys concluded, “OVATION 2 is designed to
define the optimal dose of GEN-1 and provide important insights
into GEN-1's clinical benefit as an adjuvant therapy both before
and after debulking surgery with the potential to stimulate an
anticancer immune response, compared to the current standard of
care alone."
In the prior Phase Ib OVATION I Study, Celsion
reported promising clinical findings including objective responses
(complete response + partial response) in all patients at the two
highest dose cohorts, along with an 87.5% rate of R0
(margin-negative) resections in the two highest dose cohorts and a
100% rate of R0 resections in the highest dose cohort at time of
debulking surgery. Additionally, translational research data
demonstrates that GEN-1 is biologically active, producing
beneficial cytokines and positively impacting T-cell population in
the tumor.
“We are very excited to advance our ovarian
cancer research, which is based on the known and highly potent
anti-cancer agent IL-12. We believe GEN-1, our novel, gene-mediated
formulation, has the potential to effectively harness IL-12’s
antitumor activity for cancer patients with a dimension of safety
not found in the free, recombinant form,” said Michael H. Tardugno,
Celsion's chairman, president and chief executive officer.
Manufacturing Technology Transfer for
GEN-1
In order to support the future clinical
development and global market strategy of GEN-1 in ovarian cancer,
the Company is finalizing technology transfer initiatives with two
premier global manufacturers in China, Zhejiang Hisun
Pharmaceutical Co. Ltd. and Hainan Poly Pharm Co., Ltd. The Company
has completed several important technology transfer activities
relating to the manufacture of GEN-1, including studies required by
National Medical Products Administration (NMPA), the China
regulatory agency, for site approval. These important initiatives
are designed to pursue an expanded partnership for the technology
transfer relating to the clinical and commercial manufacture and
supply of GEN-1 for the greater China territory, with the option to
expand into other countries in the rest of the world after all
necessary regulatory approvals are in effect.
Key provisions of the technology transfer
initiatives are as follows:
- To provide Celsion with a high-quality, affordable,
cost-effective supply for all global markets.
- To target unit costs for clinical supplies of GEN-1 that are
substantially competitive with the Company's current
suppliers.
- Once an approved drug, the cost structure for GEN-1 is expected
to support rapid market adoption and significant gross margins
across global markets.
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 |
LHA
Investor Relations |
Jeffrey W.
Church |
Kim Sutton
Golodetz |
Executive Vice
President, CFO and Corporate Secretary |
|
609-482-2455 |
212-838-3777 |
jchurch@celsion.com |
kgolodetz@lhai.com |
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