Celsion to Host Research and Development (R&D) Day on Thursday, October 12, 2017
October 12 2017 - 11:03AM
Celsion Corporation (NASDAQ:CLSN), an oncology development company,
today announced that it will host a Research and Development
(R&D) Day for investors and analysts on Thursday, October 12,
2017. The event will take place from 4:00 to 6:00 p.m.
Eastern Time in New York City, and will be simultaneously streamed
as a webcast. A live webcast of the presentations will be
available on Celsion's website at
http://investor.celsion.com/events.cfm beginning at approximately
4:15 p.m. Eastern Time.
The presentations will focus on the Company's
research and development programs and will feature leading experts
in directed chemotherapies and immunotherapies.
ThermoDox® - Pivotal Phase III OPTIMA
Study for Primary Liver Cancer. Lead OPTIMA
Study clinical investigators representing various geographical
regions (Asia-Pacific and Europe) and multiple medical disciplines
(hepatology, interventional radiology and surgery) will present
their past and current experiences with ThermoDox® for the
treatment of primary liver cancer.
- Won Young Tak, M.D., Ph.D., Professor Internal Medicine, GI
& Hepatology Kyungpook National University Hospital Daegu,
Republic of Korea
- Stephen N. Wong, M.D., Principle Investigator OPTIMA, Chinese
General Hospital, Philippines
- 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
GEN-1 Immunotherapy – A Powerful,
Pro-Immune Modulator of Cancer’s Microenvironment. The
lead investigator for the Company’s recently completed OVATION
Study in newly diagnosed Stage III/IV ovarian cancer patients will
review all of the clinical data from the trial and a leading
immuno-oncology expert from Roswell Park Cancer Institute will
discuss the translational research data from the OVATION Study.
- Premal H. Thaker, M.D., Associate Professor in Gynecologic
Oncology, Washington University School of Medicine, St. Louis,
Missouri
- Richard C. Koya, MD, PhD, Associate Professor of Oncology and
Immunology, Director of the Vector Development & Production
Facility, Associate Director of the Center for Immunotherapy,
Roswell Park Cancer Institute, Center for Immunotherapy, Buffalo,
NY
To ensure a timely connection, users should
register at least 15 minutes prior to the scheduled start. The
webcast will be archived for replay following the event for 90
days.
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.
About the OVATION Study
The Phase Ib trial was designed to evaluate
weekly intraperitoneal dosing of GEN-1 in combination with
neoadjuvant chemotherapy, the standard of care for patients newly
diagnosed with ovarian cancer. Concurrently with neoadjuvant
chemotherapy, enrolled patients will receive escalating weekly
doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m²,
61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval
debulking surgery to follow. The regimen will primarily be
evaluated for its safety and tolerability. GEN-1, designed
using Celsion's proprietary TheraPlas platform technology, is an
IL-12 DNA plasmid vector encased in a nanoparticle delivery system,
which enables cell transfection followed by persistent, local
secretion of the IL-12 protein. IL-12 is one of the most active
cytokines for the induction of potent anti-cancer immunity acting
through the induction of T-lymphocyte and natural killer (NK) cell
proliferation.
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
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