Celsion Provides Summary of Research and Development Day Held on Thursday, October 12, 2017
October 17 2017 - 8:30AM
Celsion Corporation (NASDAQ:CLSN), an oncology development company,
today provided a summary of ThermoDox® related presentations made
during the Company’s Research and Development (R&D) Day held on
Thursday, October 12, 2017. This summary is intended to
provide easy access to pertinent, top line information discussed
during the conference. A complete webcast of the
presentations is available on Celsion's website at
www.celsion.com under the heading News & Investors / Financial
Events / Featured Events – October 12, 2017 – Celsion to Host
Research and Development Update.
The presentations focused on the Company's
research and development program using ThermoDox®, Celsion’s
proprietary heat-activated liposomal encapsulation of doxorubicin,
for the treatment of primary liver cancer, also known as
hepatocellular carcinoma or HCC. Leading OPTIMA Study
clinical investigators representing various geographical regions
(Asia-Pacific and Europe) and multiple medical disciplines
(hepatology, interventional radiology and surgery) presented their
past and current experiences with ThermoDox® for the treatment of
primary liver cancer.
-- Nicholas Borys, M.D.,
Celsion’s Senior Vice President & Chief Medical Officer,
presented the following:
- ThermoDox’s mechanism of action and how it utilizes tumor
biology to deliver high concentrations of drug (Doxorubicin)
directly to the tumor site and the importance of heating time.
- Key learnings from the Company’s 701 patient HEAT Study
including results from (i) computer simulation studies, (ii)
preclinical animal studies and (iii) a post hoc subgroup analysis,
all of which establishes a clear understanding of a key ThermoDox®
heat-based mechanism of action: the longer the target tissue is
heated, the greater the doxorubicin tissue concentration.
- Hypothesis prompted by the HEAT Study post-hoc findings:
ThermoDox®, when used in combination with Radiofrequency Ablation
(RFA) standardized to a minimum dwell time of 45 minutes (sRFA >
45 min), appears to increase the overall survival (OS) of patients
with HCC.
- Results from an independent retrospective analysis conducted by
the National Institutes of Health on the intent-to-treat population
of the HEAT Study which sought to evaluate the correlation between
RFA burn time per tumor volume (min/ml) and clinical outcome. The
analysis concluded that increased RFA “burn time” per tumor volume
significantly improved overall survival (OS) in patients with
solitary lesions treated with sRFA + ThermoDox® compared to
patients treated with sRFA alone.
- Update on the current enrollment status of the OPTIMA Study
which is approaching 70% of the 550 patients necessary to ensure
that its primary end point, overall survival, can be evaluated with
statistical significance. The statistical plan for the OPTIMA Study
calls for two interim efficacy analyses by the IDMC. The Company
projects full patient enrollment by mid-2018 and the first
pre-planned efficacy analysis after 118 overall survival events by
the first quarter of 2019.
-- Won Young Tak, M.D., Ph.D., Professor
Internal Medicine, GI & Hepatology Kyungpook National
University Hospital Daegu, Republic of Korea presented the
following:
- RFA has limited efficacy in larger tumors due to microsatellite
nodules or viable tumors.
- Patients treated with ThermoDox® in the HEAT Study had
excellent survival outcome. Two cases presented for the HEAT
Study showed five and nine year survival benefit for patients
treated with ThermoDox® plus sRFA.
-- Stephen N. Wong, M.D., Principal
Investigator OPTIMA, Chinese General Hospital, Philippines
presented the following:
- HEAT Study patients treated with ThermoDox® demonstrated a high
complete response rate compared to other studies
- A strong correlation exists between complete response and
better survival.
-- Robert M. Eisele, M.D.,
Deputy Head of Department, Dept. of General, Visceral, Vascular and
Pediatric Surgery, Medical Faculty of the University of Saarland,
Homburg, Germany presented the following:
- HCC is a worldwide problem with high incidence that continues
to rise.
- Treatment strategies for treating HCC should be tailored.
- Until ThermoDox®, RFA was insufficient in treating intermediate
to large tumors.
- Data from the HEAT Study suggests a new role for RFA plus
ThermoDox® in HCC – a “promising option.”
About the OPTIMA Study
The Phase III OPTIMA Study is expected to enroll
up to 550 patients in up to 70 clinical sites in the United States,
Europe, China and Asia Pacific, and will evaluate ThermoDox® in
combination with optimized RFA, which will be standardized to a
minimum of 45 minutes across all investigators and clinical sites
for treating lesions three to seven centimeters, versus optimized
RFA alone. The primary endpoint for the trial is Overall Survival,
which is supported by post-hoc analysis of data from the Company's
701 patient HEAT Study, where optimized RFA has demonstrated the
potential to significantly improve survival when combined with
ThermoDox®. The statistical plan calls for two interim efficacy
analyses by an independent Data Monitoring Committee.
ThermoDox® has received U.S. FDA Fast Track
Designation and has been granted orphan drug designation for
primary liver cancer in both the U.S. and Europe. Further, the U.S.
FDA has provided ThermoDox® with a 505(b)(2) registration
pathway. Subject to a successful trial, the OPTIMA Study has
been designed to support registration in all key primary liver
cancer markets. Celsion fully expects to submit registrational
applications in the USA, Europe and China. The Company believes
that applications will be accepted in South Korea, Taiwan and
Vietnam, three other large and important markets for ThermoDox®
subject to approval in Europe, China or the USA.
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 DNA-based 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 anti-cancer DNA or RNA
therapies. For more information on Celsion, visit our
website: http://www.celsion.com. (CLSN-LTSL/ThermoDox® CLSN-Optima
Study/HCC) (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.
Celsion Investor Contact
Jeffrey W. Church Sr. Vice President and CFO 609-482-2455
jchurch@celsion.com
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Apr 2023 to Apr 2024