LAWRENCEVILLE, N.J.,
Feb. 27, 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 will enroll 20 patients at 5 clinical sites in the United States and is evaluating ThermoDox
in combination with mild hyperthermia. Based on data available to
date, a local response rate of 80% has been observed in the 5
evaluable patients with refractory disease, notably 2 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.
"These results are very impressive, especially given the fact
that Recurrent Chest Wall Breast Cancer is difficult to treat, has
a poor prognosis with a significant impact on quality of life, and
that these patients have failed all previous treatment attempts,"
said Professor Hope S. Rugo, MD,
UCSF School of Medicine, the lead investigator for the DIGNITY
trial. "I am particularly encouraged by the consistency of the
efficacy signals observed in this trial and the earlier Phase 1
studies, which provide further evidence that ThermoDox in
combination with hyperthermia may offer a clinically meaningful
treatment option for this underserved patient population."
"The data emerging from the Phase 2 DIGNITY program underscore
the ThermoDox value proposition and reflect the broad potential for
ThermoDox across a range of solid tumor indications," stated
Nicholas Borys, M.D., Chief Medical
Officer of Celsion. "With the trial now approximately 50% enrolled,
we are focused on driving patient recruitment and look forward to
continued updates from this trial."
In December, Celsion 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. 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. ThermoDox® in combination with mild hyperthermia was
evaluated in these patients in up to six cycles. Both studies
employed an open label 3+3 dose escalation study design to
determine the Maximum Tolerated Dose (MTD), evaluate safety and
determine early effects of ThermoDox® in combination with mild
hyperthermia. 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.
About Celsion Corporation
Celsion is dedicated to the development and commercialization of
innovative cancer drugs, including tumor-targeting treatments using
focused heat energy in combination with heat-activated liposomal
drug technology. Celsion has research, license or
commercialization agreements with leading institutions, including
the National Institutes of Health, Duke
University Medical Center, University
of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the
Kyungpook National University Hospital,
the Beijing Cancer Hospital and the University of Oxford. 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