Celsion Corporation (NASDAQ: CLSN), a leading oncology drug
development company, today jointly announced with Medidata, a
Dassault Systèmes company, that examining matched patient data
provided by Medidata in a synthetic control arm (SCA) with results
from the Company’s completed Phase Ib dose-escalating OVATION I
Study with GEN-1 in Stage III/IV ovarian cancer patients showed
positive results in progression-free survival (PFS). The hazard
ratio (HR) was 0.53 in the intent-to-treat (ITT) group, showing
strong signals of efficacy. 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.
Celsion believes these data may warrant
consideration of strategies to accelerate the clinical development
program for GEN-1 in newly diagnosed, advanced ovarian cancer
patients by the U.S. Food and Drug Administration (FDA). In its
March 2019 discussion with Celsion, the FDA noted that preliminary
findings from the Phase Ib OVATION I Study were exciting but lacked
a control group to evaluate GEN-1’s independent impact on
impressive tumor response, surgical results and PFS. The Agency
encouraged the Company to continue its GEN-1 development program
and consult with FDA with new findings that may have a bearing on
designations such as Fast Track and Breakthrough Therapy.
GEN-1’s strong and encouraging treatment effect,
evidenced by the synthetic control arm, suggests a potentially
remarkable improvement in PFS, an FDA recognized surrogate for
Overall Survival, and appears to confirm the science behind IL-12’s
ability to recruit the innate and adaptive elements of the immune
system to fight malignancies. The strong PFS trend is supported
with previously published translational data that clearly
demonstrates the pro-immune changes in the tumor micro-environment
associated with loco-regional GEN-1 therapy.
Celsion’s current randomized Phase II OVATION 2
Study in advanced ovarian cancer patients will commence in the 2nd
half of 2020 and is designed to demonstrate a 33% improvement in
PFS (HR=0.75) over current standard of care. PFS is the primary
endpoint for this study.
Synthetic Control Arms have the potential to
revolutionize clinical trials in certain oncology indications and
some other diseases where a randomized control is not ethical or
practical. SCAs are formed by carefully selecting control patients
from historical clinical trials to match the demographic and
disease characteristics of the patients treated with the new
investigational product.
SCAs have been shown to mimic the results of
traditional randomized controls so that the treatment effects of an
investigational product can be visible by comparison to the SCA.
SCAs can help advance the scientific validity of single arm trials,
and in certain indications, reduce time and cost, and expose fewer
patients to placebos or existing standard-of-care treatments that
might not be effective for them. Medidata is in a unique position
to create fit-for-purpose synthetic controls because of access to a
pool of more than six million anonymized patients from nearly
20,000 previous clinical trials.
“Acorn AI, by Medidata, is proud to partner with
Celsion to create a Synthetic Control Arm for this important
clinical trial in advanced ovarian cancer patients with unmet
medical needs,” said Ruthie Davi, Ph.D., vice president, Data
Science at Acorn AI, by Medidata. “This could have game-changing
implications for patients, the medical community, and the industry.
As demonstrated with the SCA for the OVATION I Study, we now have
the opportunity to gain early scientific clarity to expedite the
development of potentially life-saving treatments.”
PFS data generated from this analysis comparing
GEN-1 with SCA showed the following:
GEN-1 Population |
PFS Hazard Ratio (Confidence Interval) |
Intent-to-treat, n=15 |
0.53 (95% CI 0.16, 1.73); log-rank p=0.29 |
Per-protocol, n=14 |
0.33 (95% CI 0.08, 1.37); log-rank p=0.11 |
“The patients in the GEN-1 arm of the OVATION I
Study virtually demonstrated a doubling of control of their cancer
than the Synthetic Control Arm. Although these findings are not
statistically significant due to the small numbers, they are
impressive nonetheless,” said Dr. Nicolas Borys, Celsion’s chief
medical officer. “This preliminary evidence of a strong treatment
effect trend supports our commitment to the GEN-1 program, and we
will aggressively explore means of accelerating its development
with regulatory agencies and our investigators.”
The Phase Ib OVATION I Study evaluated
escalating doses of GEN-1 (36 mg/m2, 47 mg/m2, 61 mg/m2 and 79
mg/m2) administered intraperitoneally in combination with three
cycles of neoadjuvant chemotherapy (NACT) prior to interval
debulking surgery, followed by three cycles of NACT in the
treatment of newly diagnosed patients with Stage III/IV ovarian
cancer. Previously reported data demonstrated median PFS of 21
months in the per-protocol population and 17.1 months in the
intent-to-treat population for all dose cohorts, comparing
favorably to historically reported median PFS of 12 months.
In the OVATION I Study, complete tumor
resections (R0s) were achieved for all patients receiving the
highest (79 mg/m2) dose of GEN-1, and approximately 86% of patients
in OVATION I had a complete or partial response. All patients
experienced a clinically significant decrease in their CA-125
protein levels as of their latest 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. GEN-1 was well tolerated and no dose-limiting
toxicities were detected. Intraperitoneal administration of GEN-1
was feasible with broad patient acceptance.
“We are extremely impressed with the high
quality of the matched data from the Medidata SCA,” said Michael H.
Tardugno, Celsion’s chairman, president and chief executive
officer. “They were able to provide near-perfect matches for
patient characteristics in our Phase Ib OVATION I Study. Based on
this capability and the remarkable potential demonstrated by GEN-1,
we plan to move forward with a partial synthetic control arm for
the Phase II portion of our Phase I/II OVATION 2 Study with GEN-1
in advanced ovarian cancer. Using a SCA for a portion of the study
will reduce costs and should improve the rate of enrollment as
patients will be more likely to receive GEN-1 rather than
placebo.”
About Medidata
Medidata is leading the digital transformation
of life sciences, creating hope for millions of patients. Medidata
helps generate the evidence and insights to help pharmaceutical,
biotech, medical device and diagnostic companies, and academic
researchers accelerate value, minimize risk, and optimize outcomes.
More than one million registered users across 1,400 customers and
partners access the world's most-used platform for clinical
development, commercial, and real-world data. Medidata, a Dassault
Systèmes company (Euronext Paris: #13065, DSY.PA), is headquartered
in New York City and has offices around the world to meet the needs
of its customers. Discover more at www.medidata.com and follow us
@Medidata , The Operating System for Life SciencesTM.
About Acorn AI
Acorn AI, by Medidata, a Dassault Systèmes
company, combines data, technology, and deep expertise to help life
sciences companies deliver actionable insights across the entire
continuum of clinical development. Acorn AI’s advanced analytics
answers the most important questions in R&D and
commercialization including accelerating breakthrough innovation,
optimizing study execution and commercial success, and
demonstrating the value of therapies. Built upon the Medidata
platform comprising nearly 20,000 trials and more than six million
patients, Acorn AI products feature the industry’s largest
structured, standardized clinical trial data repository connected
with real world, translational, and other datasets. For more
information, please visit www.medidata.com/acornai.
Medidata and Acorn AI are registered trademarks
of Medidata Solutions, Inc., a wholly-owned subsidiary of Dassault
Systèmes.
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, EVP, CFO and Corporate Secretary |
Kim Sutton Golodetz |
609-482-2455 |
212-838-3777 |
jchurch@celsion.com kgolodetz@lhai.com |
|
Medidata, Acorn AI Media
ContactCaroline
Drucker347-675-3222cdrucker@medidata.com
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