LAWRENCEVILLE, N.J.,
July 6, 2015 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN) announced today positive interim data
from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox® in
recurrent chest wall (RCW) breast cancer. The trial is
designed to enroll up to 20 patients at several U.S. clinical sites
and is evaluating ThermoDox in combination with mild hyperthermia.
Of the 17 patients enrolled and treated, 13 were eligible for
evaluation of efficacy. Based on data available to date, every
patient experienced a clinical benefit of their highly refractory
disease within the ThermoDox treatment field, with a local response
rate of 69% observed in the 13 evaluable patients, notably five
complete responses (CR), four partial responses (PR) and four
patients with stable disease (SD). The Company will complete
enrollment in the study in the third quarter of 2015.
"We have observed durable local responses in two-thirds of the
patients treated using ThermoDox® in three clinical trials to-date,
which is significant considering the fact that these patients
present with highly resistant chest wall tumors that had progressed
on multiple previous therapies, including chemotherapy, radiation
and hormone therapy," noted Dr. Nicholas
Borys, Celsion's senior vice president and chief medical
officer. "We are aggressively pursuing opportunities to
expand this program into Europe
through the EURO-DIGNITY trial in which we expect to treat our
first patient very soon."
These data are consistent with previously published Phase 1 data
for ThermoDox® plus hyperthermia in RCW breast cancer. The two
similarly designed Phase 1 studies enrolled patients with highly
resistant tumors found on the chest wall and who had progressed on
previous therapies. Of the 29 patients treated in the two
trials, 23 were eligible for evaluation of efficacy. A local
response rate of 61% was reported in 14 of the 23 evaluable
patients, with five complete responses and nine partial
responses. A Clinical Response Rate (CR+PR+SD) was observed
in 87% of the evaluable patients.
"These extremely impressive data position us to successfully
pursue and take advantage of promising opportunities to accelerate
the development and commercialization of ThermoDox® in RCW breast
cancer patients as we turn our attention to Europe and the initiation of EURO-DIGNITY, a
multi-center study designed to evaluate ThermoDox's potential to
locally control chest wall lesions in earlier stage patients,"
stated Michael H. Tardugno, Celsion's chairman, president
and CEO. "Together, through our partnership with myTomorrows and
our Early Access Program, our goal is faster commercialization and
near-term revenue benefitting patients who are in dire need of more
rapid access to new and better options for the treatment of this
aggressive form of breast cancer."
The EURO-DIGNITY trial will evaluate ThermoDox® plus
hyperthermia and radiation in earlier stage breast cancer patients
and is designed to support a registration filing in Europe.
This study will be conducted in five countries with the support of
key European investigators and with assistance from MedLogics
Corporation, a hyperthermia device company based in Italy. 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 plus Switzerland for the
treatment of patients with RCW breast cancer. The Company expects
to have ThermoDox® available in mid-2015 for sale at commercial
prices to physicians who are treating patients with limited
therapeutic options. The EAP provides physicians with access to
products in later stage development that demonstrate evidence of
clinical benefit with an acceptable safety profile and a quality
manufacturing process in place.
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.
The pipeline also includes EGEN-001, a DNA-based immunotherapy for
the localized treatment of ovarian and brain cancers. Celsion
has three platform technologies for the development of novel
nucleic acid-based immunotherapies and other anti-cancer DNA or RNA
therapies, including TheraPlas™, TheraSilence™ and RAST™. 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; 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; HEAT Study data
is subject to further verification and review by the HEAT Study
Data Management Committee; the need for Celsion to evaluate its
future development plans; possible acquisitions or licenses of
other technologies, assets or businesses or the possible failure to
make such acquisitions or licenses; 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
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation