LAWRENCEVILLE, N.J.,
Dec. 14, 2015 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN) today announced the presentation of
results from its ongoing Phase I/II US DIGNITY Study of
ThermoDox® in combination with mild hyperthermia in
patients with recurrent chest wall (RCW) breast cancer. The
data, which demonstrated a combined local response rate of 61.9%
among evaluable patients treated with ThermoDox®, were
presented on Saturday, December 12,
2015 at the San Antonio Breast Cancer Symposium during a
poster session titled New Drugs and Treatment Strategies.
Celsion Corporation is a fully-integrated oncology company
focused on the development of a portfolio of innovative cancer
treatments, including directed chemotherapies, immunotherapies and
RNA- or DNA-based therapies for the treatment of cancer and other
difficult-to-treat diseases.
"Results from this study are very encouraging and suggest that
ThermoDox® combined with superficial hyperthermia offers
a promising and well tolerated treatment option for patients with
recurrent chest wall disease from breast cancer, a highly
refractory form of breast cancer associated with poor quality of
life and limited treatment options," said Hope Rugo, M.D., Clinical Professor, Department
of Medicine and Director, Breast Oncology Clinical Trials Program
at the University of California, San
Francisco, and lead investigator of the study. "These
findings underscore the potential for this therapy to serve as a
much needed treatment for these patients, and further define the
importance of advancing development of ThermoDox® in
this indication," Dr. Rugo added.
In the Phase I/II trials, which were designed to evaluate the
safety and anti-tumor activity of ThermoDox® in
combination with mild hyperthermia in RCW breast cancer, a total of
28 patients were treated at doses of either 40 or 50
mg/m2. In addition to a local response rate of 61.9%
among evaluable patients, a combined local response rate was
observed in 46.4% of the intent-to-treat population (13/28),
notably consisting of five patients demonstrating a durable local
response lasting greater than three months, including four complete
responses (CR) and one partial response (PR). Patients dosed
at 40 mg/m2 displayed a comparable response rate and a
more favorable safety profile to that of patients receiving 50
mg/m2. As a result, 40 mg/m2 will be
the recommended dose for future clinical trials in this
indication.
"ThermoDox® in RCW breast cancer continues to yield
striking response data in this vulnerable patient population,
further validating our commitment to expanding this program,
including the initiation of the Euro-DIGNITY Trial, a multi-center
study designed to evaluate ThermoDox's potential to locally control
chest wall lesions in earlier-stage patients," said Michael H. Tardugno, Celsion's chairman,
president and CEO. "Additionally, we remain committed to providing
patients who are suffering from this aggressive form of breast
cancer with access to ThermoDox®, and are continuing to
work closely with myTomorrows to ensure the success of our Early
Access Program in Europe for
ThermoDox® in RCW breast cancer."
The Company anticipates completion of the Phase II US DIGNITY
trial by year-end, and plans to initiate a 70 patient Phase II
study in Europe and Israel in less advanced, less heavily
pretreated patients as part of the Euro-DIGNITY Trial. The
Euro-DIGNITY Trial will evaluate ThermoDox® plus
radiation and hyperthermia in RCW breast cancer patients and is
designed to support a registration filing in Europe. This
study will be initiated throughout Europe and Israel and with assistance from MedLogics
Corporation, an Italian-based hyperthermia device company. In
addition, Celsion has a license and distribution agreement with
myTomorrows to implement an Early Access Program (EAP) for
ThermoDox® in all countries of the European Union
territory plus Switzerland for the
treatment of patients with RCW breast cancer. The EAP provides
physicians with access to products in later stage development
demonstrating evidence of clinical benefit, with an acceptable
safety profile and a quality manufacturing process in place.
The poster presentation is available on Celsion's website at
http://investor.celsion.com/events.cfm.
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, including TheraPlas™ and TheraSilence™. For more
information on Celsion, visit our website:
http://www.celsion.com.
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; FDA and regulatory
uncertainties and risks; the significant expense, time, and risk of
failure of conducting clinical trials; 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 Media Contacts
Harriet Shelare
Director, Communications
860-483-1721
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation