Celsion Announces Positive Interim Data from Phase 2 DIGNITY Trial in Breast Cancer

 Celsion Announces Positive Interim Data from Phase 2 DIGNITY Trial in Breast
                                    Cancer

ThermoDox Demonstrates Impressive Response Rate in Refractory Patients

PR Newswire

LAWRENCEVILLE, N.J., Feb. 27, 2014

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

Website: http://www.celsion.com
 
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