LAWRENCEVILLE, N.J.,
Sept. 4, 2014 /PRNewswire/
-- September 4, 2014 /PRNewswire/ -- Celsion Corporation
(NASDAQ: CLSN) today announced that data from two Phase I studies
on ThermoDox® in recurrent chest wall breast cancer were published
in the International Journal of Hyperthermia. The article,
titled "Two phase 1 dose-escalation/pharmacokinetics studies of low
temperature liposomal doxorubicin (LTLD) and mild local
hyperthermia in heavily pretreated patients with local regionally
recurrent breast cancer," appears in the August 2014 issue (Volume 30, Number 5) and can
be accessed here.
"Data from the two Phase I studies published in this
peer-reviewed journal demonstrate that in heavily pretreated
patients with unresectable recurrent chest wall breast cancer
(RCWBC), treatment with 50 mg/m² of ThermoDox® combined with mild
local hyperthermia is safe and produces objective responses in
heavily pretreated RCWBC patients, a particularly
difficult-to-treat patient population," said Mark Dewhirst, DVM, Ph.D., Vice Director for
Basic Science, Duke Cancer Institute, Gustavo S. Montana Professor
of Radiation Oncology in the School of Medicine, Professor of
Pathology, Duke School of Medicine.
Nicholas Borys, M.D., Senior Vice
President and Chief Medical Officer of Celsion, added, "We believe
that the results of the Phase I studies reported in the journal are
both consistent and compelling. This adds to Celsion's recent
interim data reported from our ongoing Phase II DIGNITY trial of
ThermoDox® in recurrent chest wall recurrent breast cancer, which
further supports our belief that continued development of
ThermoDox® in patients with RCWBC is important. We look forward to
continuing to advance our ThermoDox® clinical development program
in a variety of cancers, particularly primary liver cancer, early
stage breast cancer, colorectal liver metastases, pancreatic cancer
and metastatic liver cancer."
The article describes the combined results of the two similarly
designed Phase I trials with one study conducted at Duke University and the second study conducted at
other major breast cancer centers in the U.S., in which eligible
patients with unresectable chest wall recurrences had progressed on
the chest wall after prior hormone therapy, chemotherapy, and
radiotherapy. Patients received up to six cycles of ThermoDox®
every 21-35 days, followed immediately by chest wall mild local
hyperthermia for 1 hour at 40-42°C. In the first trial, 18 subjects
received ThermoDox® at 20, 30, or 40 mg/m²; in the second trial, 11
subjects received ThermoDox® at 40 or 50 mg/m². The results showed
that the maximum tolerated dose was 50 mg/m². The rate of overall
local response was 48%, with five patients (17%) achieving complete
local responses and nine patients (31%) having partial local
responses. It was concluded that ThermoDox® at 50 mg/m² and mild
local hyperthermia was safe, and this combined therapy produces
objective responses in heavily pretreated RCWBC patients.
Importantly, these Phase I data are consistent with the
impressive interim results from Celsion's ongoing open-label Phase
II DIGNITY Study of ThermoDox® in RCWBC. The DIGNITY Study
will enroll a minimum of 20 patients at several U.S. clinical sites
and is evaluating ThermoDox® in combination with mild hyperthermia
using a treatment design equivalent to that used in the Phase I
programs. 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).
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™ and TheraSilence™. 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; 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