Celsion Announces Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients
January 17 2017 - 8:00AM
Fourth Cohort of Patients Continues to Show
Clinically Meaningful Responses in the Evaluation of GEN-1, A Novel
IL-12 DNA-based Immunotherapy, in Combination with the Standard of
Care
Celsion Corporation (NASDAQ:CLSN) today announced data from
the fourth cohort of patients in 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 followed
by interval debulking surgery. In the first twelve patients
dosed in the OVATION Study, GEN-1 plus standard chemotherapy
produced impressive results, with no dose limiting toxicities and
highly promising efficacy signals in this difficult to treat
cancer.
“These early results have impressed our
investigators which accounts for the rapid patient accrual in the
study. 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,” said Nicholas Borys, M.D.,
Celsion's chief medical officer. “In particular, we see
improvements across a number of important and meaningful measures
used to assess ovarian cancer, which reinforce our confidence in
this IL-12 immunotherapy approach and provide a strong rationale
for continued development of GEN-1 for the treatment of ovarian
cancer. We look forward to the translational data which, along with
the clinical findings, will assist in the design of our
registrational program.”
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. The first four cohorts have each
enrolled three patients. Enrollment in the fourth cohort is
ongoing with the goal of enrolling three additional patients in
this final dose cohort. Celsion expects to complete
enrollment in the OVATION Study this quarter and report final data,
including translational data for all patients in the second quarter
of 2017. Future studies of GEN-1 will include a Phase I/II study
combining GEN-1 with Avastin® and Doxil®.
OVATION Study – Totality of Results in
the First Four Patient Cohorts
- Of the first twelve patients dosed, one patient demonstrated a
complete response (CR), eight patients demonstrated a partial
response (PR) and three patients demonstrated stable disease (SD),
as measured by RECIST criteria. This translates to a 100%
disease control rate (DCR), and 75% objective response rate
(ORR). These results compare very favorably to the current
standard of care.
- Eleven 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.
OVATION Study – Top Line Translational
Data from First Two Cohorts
Celsion previously reported initial
translational data from the first two cohorts of the OVATION
study. Tumor and blood samples collected before the start of
the neoadjuvant chemotherapy (NACT) and after the completion of
GEN-1 treatment at debulking surgery are being analyzed for immune
cell populations. Top line data demonstrates intriguing
immunological changes in the tumor that are consistent with the
activation of the immune system. For example, the ratio of
CD8+/FoxP3+ cells was increased in all four evaluable
patients. High tumor infiltrating CD8+ T-cell density, low
FoxP3+ T-cell density or high CD8+/FoxP3+ ratio demonstrate a
potential shift in tumor environment to favoring immune stimulation
following NACT + GEN-1 therapy. For the remaining two
patients the post-treatment tumor tissue was not available.
In one of those two patients there was complete pathological
response hence no tumor tissue was present to provide a
post-treatment comparison. In the other patient the debulking
surgery was not performed due to disease related complications.
Complete immune analysis of biological tissue including
cytokine ELISA from all four patient cohorts is in progress.
“These results build on the impressive clinical
findings we observed in our earlier GOG Study as well as the
translational data from this same study. As we move closer towards
the final design of a Phase I/II trial to evaluate the synergistic
anti-cancer effects of GEN-1 together with Avastin® and Doxil®,
these results also provide strong clinical evidence for the
potential of GEN-1 in ovarian cancer,” said Michael H. Tardugno,
Celsion's chairman, president and chief executive officer. “We
anticipate completion of enrollment in the fourth and final patient
cohort in the coming quarter. In parallel, we are currently
collecting full translational data from the study, which we expect
to report in the first half of this year.”
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.
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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