Celsion Announces Presentation of OVATION Study Findings at the Upcoming ASCO 2017 Annual Meeting
April 20 2017 - 8:30AM
Celsion Corporation (NASDAQ:CLSN), an oncology drug development
company, today provided an update on its OVATION Study, a Phase Ib
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 (stage III/IV)
ovarian cancer who will undergo neoadjuvant chemotherapy followed
by interval debulking surgery. GEN-1 is an IL-12 DNA plasmid
vector formulated as a nanoparticle in a non-viral delivery system
to cause the sustained local production and secretion of the
Interleukin-12 (IL-12) protein loco-regionally to the tumor
site.
The Company announced that an abstract for the
OVATION Study has been accepted for presentation at the American
Society of Clinical Oncology (ASCO) 2017 Annual Meeting, which will
take place from June 2-6 at McCormick Place in Chicago, IL.
- The abstract, entitled "Phase 1 study of the safety and
activity of formulated IL-12 plasmid administered intraperitoneally
in combination with neoadjuvant chemotherapy in patients with newly
diagnosed advanced stage ovarian cancer," will be presented in a
poster presentation session on Saturday, June 3rd from 1:15 PM to
4:45 PM by Dr. Premal H. Thaker, Associate Professor, Obstetrics
and Gynecology Division of Gynecologic Oncology, Washington
University in St. Louis School of Medicine.
- The presentation will summarize clinical findings and
translational data from all available patients treated in the
trial. The translational data will provide further insight
into GEN-1's mechanism of action through the evaluation of
dose-related changes in the tumor and peritoneal immune cell
population, as well as through the peritoneal cytokine levels.
Celsion has previously reported highly encouraging
interim data from the first twelve patients who have completed
treatment in the OVATION Study. GEN-1 plus standard
chemotherapy produced excellent results, with no dose limiting
toxicities and promising dose dependent efficacy signals which
appear to correlate well with successful surgical outcomes as
summarized below:
- Of the twelve patients treated, one patient demonstrated a
complete response, eight (8) patients demonstrated a partial
response and three (3) patients demonstrated stable disease, as
measured by RECIST criteria. This translates to a 100% disease
control rate (“DCR”) and a 75% objective response rate
(“ORR”).
- Eleven patients had successful resections of their tumors, with
six (6) patients (55%) having an R0 resection, which indicates a
microscopically margin-negative resection in which no gross or
microscopic tumor remains in the tumor bed, and four (4) patients
(36%) having a R1 resection, indicating microscopic residual
tumor.
- One patient demonstrated a pathological complete response
(pCR). pCRs are typically seen in less than 7% of patients
receiving neoadjuvant chemotherapy followed by surgical resection,
and have been associated with a median overall survival (OS) of 72
months, which is more than three years longer than those who do not
experience a pCR.
- All patients experienced a dramatic decrease in their CA-125
protein levels as of their most recent study visit. CA-125 is used
to monitor certain cancers during and after treatment. CA-125 is
present in greater concentrations in ovarian cancer cells than in
other cells.
"We have now completed enrollment of our OVATION
Study in newly diagnosed ovarian cancer patients, one goal of which
is to determine GEN-1’s activity in combination with standard
chemotherapy. The previously reported remarkable, unexpected
surgical outcomes among all patients completing the prescribed
eight weekly treatments reinforce our confidence in the promise of
GEN-1’s ability to work safely and effectively in advanced ovarian
cancer," said Michael H. Tardugno, Celsion's chairman, president
and CEO. “We are looking forward to Dr. Thaker’s report of
comprehensive findings at the upcoming ASCO meeting and to learning
more about the utility of our gene-based immunotherapy approach as
this important study matures."
OVATION Study Design
The Phase Ib trial will evaluate weekly
intraperitoneal dosing of GEN-1 in combination with neoadjuvant
chemotherapy, the standard of care for patients newly diagnosed
with ovarian cancer. Concurrently with neoadjuvant chemotherapy,
enrolled patients will receive escalating weekly doses of GEN-1,
from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m²
weekly for 8 treatments in total, with interval debulking surgery
to follow. The regimen will primarily be evaluated for its safety
and tolerability.
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 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 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, 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 the 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
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