Celsion and Medidata to Present Findings on Use of Synthetic Control Arm to Estimate Treatment Effect in Ovarian Cancer Trial
April 06 2022 - 8:30AM
Celsion Corporation (NASDAQ: CLSN) a clinical-stage company focused
on DNA-based immunotherapy and next generation vaccines and
Medidata, a Dassault Systèmes company, today announced that they
will be presenting their findings on the use of a Synthetic Control
ArmⓇ (SCA) in a completed Phase Ib dose-escalating study of GEN-1
in the neoadjuvant treatment of patients with Stage III/IV ovarian
cancer (the OVATION 1 Study) at the Annual Meeting of the American
Association for Cancer Research (AACR) being held on April 8-13,
2022 in New Orleans, LA.
In a poster presentation entitled “Phase IB
trial efficacy estimates via a clinical trial synthetic control
arm”, taking place on Monday April 11th 2022 from 9 AM through
12:00 PM EST , Dr. Elizabeth Lamont will present the research
team’s findings that demonstrate how comparing patients from a
single-arm trial can help enhance understanding of treatment
effects in advance of randomized trials, inform drug development
and trial design, and increase the scientific value of early phase
trials.
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. 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.
“The Medidata Synthetic Control Arm provided
reliable estimates of the efficacy endpoints, which allowed for a
decrease in the number of patients needed to participate in the
subsequent randomized Phase II trial. In addition to decreasing the
burden on patients, this helped to accelerate trial timelines and
decrease costs,” said Dr. Nicholas Borys, Chief Medical Officer at
Celsion. “This truly important progress will lead to further
insights and advancements in future trials and, in the end, help
bring treatments to patients faster.”
A Synthetic Control Arm is a type of external
control and is formed by carefully matching patients treated with a
new investigational therapy to anonymized clinical trial patients
from Medidata’s extensive repository of historical clinical trials
using baseline demographic and disease characteristics. Using this
advanced statistical methodology, Celsion and Medidata found that
progression-free survival was prolonged for the patients treated
with the investigational therapy GEN-1 along with standard of care
chemotherapy in the OVATION 1 Study compared to well-balanced
historic control patients treated with the same standard of care
chemotherapy alone (Hazard Ratio=0.53, 95% Confidence Interval
(0.16, 1.73). This larger than expected effect size led to a
decrease in the number of planned patients for Celsion’s subsequent
Phase II trial and was used in support of Fast Track Designation
from the U.S. Food and Drug Administration (FDA) received in
February 2021.
“Medidata Acorn AI is in a unique position to
create fit-for-purpose synthetic controls because of access to a
pool of more than eight million anonymized patients from 27,000+
previous clinical trials,” said Ruthie Davi, Ph.D., vice president,
Data Science at Medidata Acorn AI. “Our AACR presentation with
Celsion will show how the SCA can provide a scientifically rigorous
comparison in scenarios where a control group is not part of the
study design or hard to recruit or retain. We are proud to be
working to decrease the patient burden, enhance scientific value,
and accelerate studies.”
About Celsion
Corporation
Celsion is a fully integrated, clinical
stage biotechnology company focused on advancing a portfolio of
innovative cancer treatments, including immunotherapies and
DNA-based therapies; and a platform for the development of nucleic
acid vaccines currently focused on SARS-CoV2. The company’s product
pipeline includes GEN-1, a DNA-based immunotherapy for the
localized treatment of ovarian cancer. Celsion also has two
platform technologies for the development of novel nucleic
acid-based immunotherapies and other anti-cancer DNA or RNA
therapies. Both are novel synthetic, non-viral vectors with
demonstrated capability in nucleic acid cellular transfection. For
more information on Celsion,
visit www.celsion.com.
Forward-Looking Statements
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:Jeffrey W. ChurchExecutive Vice President and
CFO609-482-2455jchurch@celsion.com
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