Celsion Updates Clinical Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients
May 04 2017 - 8:00AM
Celsion Corporation (NASDAQ:CLSN) today announced updated
additional clinical and translational research data from its Phase
Ib dose escalating clinical trial (the OVATION Study) combining
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 neoadjuvant
chemotherapy (NACT) followed by interval debulking surgery.
Of the five evaluable patients in the first two cohorts who have
been on the study for over one year, only one patient’s cancer has
progressed after 11.7 months. This compares quite favorably
to the historical median progression free survival (PFS) of 12
months for newly-diagnosed patients with Stage III and IV ovarian
cancer who undergo neoadjuvant chemotherapy (NACT) followed by
interval debulking surgery. Of the remaining four patients in
the first two cohorts, their average PFS is 15.1 months with the
longest progression-free patient at 19.1 months. None of the
patients in the third or fourth dosing cohorts have progressed to
date.
“This new data on progression-free survival adds
to the impressive clinical findings seen across a number of
meaningful measures used to assess ovarian cancer like a 75%
objective tumor response rate and a greater than 50% R0
(margin-negative) surgical resection rate,” said Dr. Nicholas
Borys, M.D., Celsion's chief medical officer. “The consistency and
robust nature of the data across all four cohorts and the
encouraging clinical responses underscore the potential of GEN-1 to
serve as an effective, safe IL-12 immunotherapy in ovarian
cancer.”
The Company also reported preliminary
translational research findings from the first four patient
cohorts. The analysis of peritoneal fluid and blood samples
collected immediately before and 24 hours after IP administration
of multiple doses of GEN-1 (36, 47, 61, 72 mg/m2) and standard NACT
(carboplatin every 21 days and Taxol weekly) shows clear evidence
of IL-12 gene transfer by significant dose dependent increases in
IL-12 levels and immune system activity and significant increases
in IFN-gamma and decreases in VEGF levels. The
treatment-related changes in immune activating cytokines and
pro-tumor VEGF levels followed a dose-dependent trend and were
predominantly in the peritoneal fluid compartment with little to no
changes observed in the patients’ systemic blood stream.
The immuno-histochemical (IHC) analysis of tumor
tissue collected before treatment (laparoscopy) and after
completion of eight GEN-1 weekly treatments showed increased
infiltration of CD3+, CD4+ CD8+ T-cells into tumor tissue of
several patients. The most pronounced effects observed in the IHC
analysis were decreases in the density of immunosuppressive T-cell
signals (FoxP3, PD-1, PDL-1, IDO-1) in the tumor microenvironment.
The ratio of CD8+ cells to immunosuppressive cells was increased in
60-80% of patients suggesting an overall shift in the immune
environment to pro-immune stimulatory following treatment with
GEN-1.
“These translational research findings
demonstrate that GEN-1 in ovarian cancer patients is biologically
active and creates an immuno-stimulatory cytokine milieu in the
peritoneal cavity in a dose-dependent manner and promotes a
pro-immune T-cell population dynamics in the tumor
micro-environment,” said Dr. Khursheed Anwer, Celsion’s executive
vice president and chief science officer. “These distinct
immunological changes in local disease environment appear to
translate into clinical benefit and warrant the continued
development of our GEN-1 IL-12 immunotherapy as a potential
adjuvant, in both first and second-line 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 gene-mediated 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. (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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