Celsion GmbH Announces Commencement of Enrollment in Oxford University’s Phase 1 Study with ThermoDox® and Focused Ultraso...
July 01 2021 - 8:00AM
Celsion Corporation (NASDAQ:
CLSN), Celsion GmbH, a wholly owned subsidiary of Celsion
Corporation, a clinical-stage biotechnology company, announces
commencement of enrollment in Oxford University’s Phase I PanDox
study with ThermoDox® in conjunction with Focused Ultrasound in
patients with pancreatic cancer. ThermoDox® is Celsion’s
proprietary heat-activated liposomal encapsulation of doxorubicin.
This investigator-led study sponsored by the
University of Oxford and supported by the National Institute for
Health Research (NIHR) Oxford Biomedical Research Centre has now
received ethics, MHRA and institutional R&D approval to
commence (ClinicalTrials.gov Identifier: NCT04852367). PanDox is
being carried out as a multi-disciplinary collaboration between
Celsion, the Oxford University Institute of Biomedical Engineering,
the Oncology Clinical Trials Office (OCTO) and the Oxford
University Hospitals NHS Foundation Trust. Prof. Mark Middleton,
MD, Head of the Department of Oncology at the University of Oxford
is the chief clinical investigator and Prof. Constantin Coussios,
FREng, PhD, Director of the Institute of Biomedical Engineering, is
the lead scientific investigator.
The primary endpoint of the two-arm 18-subject
PanDox study is enhanced uptake of doxorubicin in pancreatic tumors
using ThermoDox® and Focused Ultrasound (FUS), compared to systemic
delivery of free doxorubicin. ThermoDox®, a heat activated
liposomal doxorubicin, will be administered intravenously in 12
patients with non-resectable pancreatic ductal adenocarcinoma
(PDAC) and locally activated by focused ultrasound-mediated
hyperthermia. This will be compared to conventional systemic
delivery of doxorubicin without FUS in 6 patients.
Secondary endpoints include:
-
Comparing radiologically assessed tumor activity and response with
ThermoDox® and FUS to free drug alone.
-
Examining the impact on patient symptoms of ThermoDox® plus
FUS.
-
Assessing the safety profile of both FUS and ThermoDox®.
The PanDox study is expected to be completed by
December 2022 and is similar in design to Oxford’s 10-patient
TARDOX study, which demonstrated that ThermoDox® plus focused
ultrasound increased doxorubicin tumor concentrations by up to
10-fold and enhanced nuclear drug uptake in patients with liver
tumors. The findings of the TARDOX study are published in Lancet
Oncology (Lyon et al., 2018) and Radiology (Gray et al., 2019).
Preclinical studies conducted at the University
of Washington and published in the International Journal of
Hyperthermia describe similarly compelling results from experiments
performed in a murine model of pancreatic cancer. Those studies
demonstrated that ThermoDox® plus focused ultrasound increased
localized concentration and nuclear uptake of doxorubicin 23-fold
compared with a 2-fold increase for hyperthermia and free
doxorubicin.
Commenting on the PanDox clinical study, Dr.
Laura Spiers, lead oncology clinical research fellow on the PanDox
study, said, “Pancreatic cancer has a low five-year survival rate
of approximately 10% and drug-based treatments remain less
effective than in other cancers, in part due to the unique
challenges presented by the stroma surrounding pancreatic tumors.
Therefore, finding innovative and effective means of delivering
high concentrations of anti-cancer agents such as doxorubicin may
lead to a breakthrough for this difficult-to-treat cancer.”
Dr. Michael Gray, lead biomedical engineering
research fellow, added, “Based on the patient-specific treatment
planning approaches developed and validated during the TARDOX
trial, PanDox will deliver focused ultrasound mild hyperthermia
without either MR-based or invasive thermometry. The ultimate goal
is to develop a cost-effective and scalable approach that can be
rapidly deployed for the benefit of pancreatic cancer
patients”.
“This Phase 1 study at Oxford University is the
first new trial to be performed under the auspices of Celsion’s
wholly owned subsidiary Celsion GmbH, which was recently
established to manage all current and future investigator-sponsored
trials with ThermoDox®,” said Andreas Voss, M.D., managing director
of Celsion GmbH. “We look forward to providing ThermoDox® and other
support to Professor Coussios as he and his colleagues strive to
provide options to pancreatic cancer patients, as well as to other
investigators pursuing compelling possibilities with
ThermoDox®.”
About Celsion
GmbH
Celsion GmbH is a wholly owned subsidiary of
Celsion Corporation based in Switzerland, whose immediate
objectives are to manage all current and future
investigator-sponsored development of ThermoDox®, the Company’s
proprietary heat-activated liposomal encapsulation of doxorubicin;
and to seek partners to develop its commercial potential. Andreas
Voss, M.D., a leading oncology researcher, has been named Managing
Director of Celsion GmbH.
About Celsion Corporation
Celsion is a 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.
About the NIHR Oxford Biomedical
Research Centre
The National Institute for Health Research
(NIHR) Oxford Biomedical Research Centre (BRC) is based at the
Oxford University Hospitals NHS Foundation Trust and run-in
partnership with the University of Oxford.
The mission of the NIHR is to improve the health
and wealth of the nation through research. We do this by:
- Funding high quality, timely
research that benefits the NHS, public health and social care.
- Investing in world-class expertise,
facilities and a skilled delivery workforce to translate
discoveries into improved treatments and services.
- Partnering with patients, service
users, careers and communities, improving the relevance, quality
and impact of our research.
- Attracting, training and supporting
the best researchers to tackle complex health and social care
challenges.
- Collaborating with other public
funders, charities and industry to help shape a cohesive and
globally competitive research system.
- Funding applied global health
research and training to meet the needs of the poorest people in
low- and middle-income countries.
- NIHR is funded by the Department of
Health and Social Care. Its work in low- and middle-income
countries is principally funded through UK Aid from the UK
government.
Forward-Looking Statements
Forward-looking statements in this news 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, statements relating to
the offering and the use of proceeds therefrom, 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 or regulatory authorities; and
other risks detailed from time to time in the Celsion's periodic
filings 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.
CONTACTS:
Celsion
CorporationJeffrey W. ChurchExecutive Vice
President and CFO609-482-2455jchurch@celsion.com
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
University of OxfordMrs. Daphne
Cunningham (PA to Professor
Coussios)+44-1865-617726daphne.cunningham@eng.ox.ac.uk
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