LAWRENCEVILLE, N.J.,
April 15, 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 16 patients enrolled and treated, 12 were
eligible for evaluation of efficacy. Based on data available to
date, 67% of patients experienced a clinical benefit of their
highly refractory disease with a local response rate of 58%
observed in the 12 evaluable patients, notably 5 complete responses
(CR), 2 partial responses (PR) and 1 patient with stable disease
(SD). The Company remains on track to complete enrollment in
the study in the third quarter of 2015.
"The objective tumor response data including 5 complete
responses emerging from the Phase 2 DIGNITY study are extremely
impressive, particularly since the patients in the trial presented
with highly resistant chest wall tumors that had progressed on
multiple therapies, including chemotherapy, radiation and hormone
therapy," noted Dr. Nicholas Borys,
Celsion's Senior Vice President and Chief Medical Officer.
"Together with the data from earlier Phase 1 studies, these interim
results highlight the significant potential of ThermoDox® plus
hyperthermia to stabilize disease in this difficult-to-treat
patient population, and we look forward to bringing this trial to
completion later this year."
These data are consistent with the previously reported Phase 1
data for ThermoDox® plus hyperthermia in RCW breast cancer,
including combined clinical data from the Company's Phase 1 DIGNITY
Study and a Duke University sponsored
Phase 1 trial of ThermoDox®. The two similarly designed studies
enrolled patients with highly resistant tumors found on the chest
wall and who had progressed on previous therapies. There were
29 patients treated in the two trials, representing 11 patients in
the DIGNITY study and 18 patients in the Duke study. Of the 29 patients treated, 23
were eligible for evaluation of efficacy. A local response
rate of over 60% was reported in 14 of the 23 evaluable patients,
with 5 complete responses and 9 partial responses.
"We are leveraging the remarkable data from our ThermoDox®
program in RCW breast cancer to accelerate the development and
commercialization of ThermoDox® in this indication in Europe," stated Michael H.
Tardugno, Celsion's chairman, president and CEO. "The
strength of the DIGNITY data is driving investigator interest in
Europe and forming the basis for
our Euro-DIGNITY trial, which is set to begin later this
quarter. In addition, we are committed to providing patients
who are suffering from this aggressive form of breast cancer with
access to ThermoDox®, and continue to work closely with myTomorrows
to launch an Early Access Program in Europe for ThermoDox® in RCW breast
cancer."
The Euro-DIGNITY trial will evaluate ThermoDox® plus
hyperthermia in RCW 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,
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 Company expects to have ThermoDox® available for sales
at commercial prices to physicians who are treating patients with
limited therapeutic options in the second quarter of 2015. 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.
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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/celsion-announces-positive-interim-data-from-its-phase-2-dignity-study-in-breast-cancer-300066032.html
SOURCE Celsion Corporation