Celsion Presents Two Posters on its GEN-1 IL-12 Gene-Mediated Immunotherapy at the ASCO-SITC Clinical Immuno-Oncology Symposi...
February 27 2017 - 8:30AM
OVATION Study Fully Enrolled, Final Patient
Enrolled in the Fourth Cohort
Celsion Corporation (NASDAQ:CLSN) today announced that
Khursheed Anwer, Ph.D., Celsion’s executive vice president and
chief science officer, presented two posters on February 23, 2017
at the American Society of Clinical Oncology (ASCO) - Society for
Immunotherapy of Cancer (SITC) Clinical Immuno-Oncology Symposium
held from February 23 – 25, 2017 in Orlando, FL. The
ASCO-SITC Clinical Immuno-Oncology Symposium focused on the latest
clinical and translational research in immuno-oncology and the
implications for clinical care.
The first poster (#155) entitled “Phase I study
and activity of formulated IL-12 plasmid administered
intraperitoneally in combination with standard neoadjuvant
chemotherapy in patients with newly diagnosed advanced stage
ovarian cancer” reported the latest clinical results from the 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 followed by interval debulking surgery.
In the first twelve patients dosed in the
OVATION Study, GEN-1 plus standard chemotherapy produced impressive
clinical results, with no dose limiting toxicities and highly
promising efficacy signals in this difficult to treat cancer.
- Of the first twelve patients dosed, one patient (8%)
demonstrated a complete response (CR), eight patients (67%)
demonstrated a partial response (PR) and three patients (25%)
demonstrated stable disease (SD), as measured by RECIST
criteria. This translates to a 100% disease control rate
(DCR), and 75% objective response rate (ORR).
- Eleven of twelve patients had successful resections of their
tumors, with six patients having an optimal R0 resection, which
indicates a microscopically margin-negative resection in which no
gross or microscopic tumor remains in the tumor bed, and four
patients with a R1 resection, indicating microscopic residual
tumor. One patient had an R2, indicating macroscopic residual
tumor. One patient in the second cohort was ineligible for
debulking surgery due to a medical complication unrelated to the
study or the study drug.
- Of the eleven surgically treated and evaluable patients, one
patient demonstrated a complete pathological response (cPR), five
patients demonstrated a micro pathological response (microPR), and
five patients demonstrated a macroPR. These data compare favorably
to historical data, which indicate that cPRs are typically seen in
less than 7% of patients receiving neoadjuvant chemotherapy
followed by surgical resection. cPRs have been associated with a
median overall survival of 72 months, which is more than three
years longer than those who do not experience a cPR. In addition,
microPRs are seen in approximately 30% of patients, and are
associated with a median overall survival of 38 months¹.
- All eleven patients who completed treatment follow-up
experienced a dramatic (greater than 90%) drop 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. A 50% reduction in CA-125 levels is considered
meaningful.
The second poster (#156) entitled “Immunological changes
following intraperitoneal administration of a formulated IL-12
plasmid in combination with standard neoadjuvant chemotherapy in
patients with newly diagnosed advanced stage ovarian cancer”
reported preliminary translational data from the OVATION Study
focusing primarily on the treatment-related changes in immune
activating and immune suppressive T-cell populations in tumor
tissue and in the levels of relevant cytokines in tumor
ascites.
- GEN-1 plus neoadjuvant chemotherapy resulted in dose-dependent
increases in IFN-g levels and decreases in VEGF levels in
peritoneal fluid, which is consistent with the results obtained
from recurrent ovarian cancer patient population treated with GEN-1
in combination with standard chemotherapy in a previous clinical
trial or in preclinical models of ovarian cancer.
- Immuno-histochemical analysis of tumor tissue for various
T-cell populations showed reduction in immunosuppressive T-cell
phenotypes in most patients. The ratio of cytotoxic CD8+ T
cells to immunosuppressive FoxP3, IDO1 and PD-1 expressing cells
was also increased in a majority of patients.
“Our hypothesis is that GEN-1 plus neoadjuvant
chemotherapy treatment will reprogram the tumor immune
microenvironment towards a potent antitumor immune response,” said
Dr. Anwer. “The available data demonstrate highly relevant
immunological changes in the tumor immune environment, which
supports the immune activating role of GEN-1 in this patient
population. We are currently analyzing the tissue
samples for additional immune cell populations and immune
cytokines, and look forward to sharing a complete set of the
clinical and translational results with the scientific and medical
community.”
The OVATION Study is designed to enroll three to
six patients per dose cohort with the goal of identifying a safe,
tolerable and immunologically active dose of GEN-1 by recruiting
and maximizing an immune response. Enrollment in the fourth and
final cohort is ongoing with the final three patients currently on
study. Celsion expects to complete the enrollment and
treatment phase of the OVATION Study early in the second quarter
and report final data, including translational data for all
patients, by the end of the second quarter of 2017.
"We are very encouraged, as have been our
Investigators, by the findings to-date in this difficult-to-treat
patient population,” said Michael H. Tardugno, Celsion's chairman,
president and CEO. “Over the past year, we have demonstrated
the potential of our GEN-1 program, in both first and second-line
ovarian cancer, and we look forward to reporting final clinical and
translational data from this important study in the second quarter
of 2017."
The two poster presentations will be available
on Celsion’s website under “News & Investors – Scientific
Presentations.”
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. 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.
¹ Petrillo M, Zannoni GF, Tortorella L, et al.
Prognostic role and predictors of complete pathologic response to
neoadjuvant chemotherapy in primary unresectable ovarian cancer.
American Journal of Obstetrics & Gynecology 2014
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
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