LAWRENCEVILLE, N.J.,
July 24, 2014 /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 Breast Cancer (RCWBC). The trial is
designed to enroll 20 patients at several U.S. clinical sites and
is evaluating ThermoDox in combination with mild hyperthermia. Of
the 13 patients enrolled and treated, 10 were eligible for
evaluation of efficacy. Based on data available to date, 60%
of patients experienced a stabilization of their highly refractory
disease with a local response rate of 50% observed in the 10
evaluable patients, notably 3 complete responses (CR), 2 partial
responses (PR) and 1 patient with stable disease
(SD).
These data are consistent with the previously reported positive
Phase 1 data in RCWBC. Celsion previously reported combined
clinical data from two Phase I trials, the Company's Phase 1
DIGNITY Study and the Duke University
sponsored Phase I trial of ThermoDox® plus hyperthermia in RCWBC in
December 2013. The two similarly
designed Phase I studies enrolled patients with highly resistant
tumors found on the chest wall and who had progressed on previous
therapy including chemotherapy, radiation therapy and hormone
therapy. There were 29 patients treated in the two trials (11
patients in the Company's 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.
"These clinical results are very encouraging, given the fact
that these patients have failed numerous previous treatments and
have limited or no treatment options for this aggressive form of
breast cancer. A chest wall recurrence of breast cancer has a
poor prognosis with a significant impact on the patients' quality
of life," said Imran Zoberi, M.D. at
Washington University in St. Louis, Mo, a principal investigator for
the DIGNITY trial. "I am pleased to be part of this important study
and look forward to continuing my involvement in the DIGNITY Study
and the future application of ThermoDox in this underserved patient
population."
"In this population, tumor response is a clinically meaningful
endpoint," noted Dr. Nicholas Borys,
Celsion's Senior Vice President and Chief Medical Officer.
"Unchecked, progression of recurrent chest wall lesions results in
severe and debilitating complications. ThermoDox's potential
to stabilize, and in many cases affect remission, may provide an
opportunity to improve quality of life; an option important for
patients and physicians in their battle with this difficult form of
malignancy."
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
SOURCE Celsion Corporation