LAWRENCEVILLE, N.J.,
Aug. 10, 2015 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN), an oncology drug development company,
today announced that it has expanded its Early Access Program (EAP)
for lyso-thermosensitive liposomal doxorubicin (LTLD), referred to
by Celsion as ThermoDox®, with myTomorrows to include patients with
primary liver cancer, also known as hepatocellular carcinoma (HCC)
and liver cancer metastases, in all countries of the European Union
(EU) territory, Switzerland,
Turkey and Israel. The
Company's original European EAP with myTomorrows, formed in
January 2015, provides eligible
patients with access to LTLD for the treatment of recurrent chest
wall (RCW) breast cancer. The EAP for LTLD was launched in
the second quarter. LTLD is Celsion's proprietary heat-activated
liposomal encapsulation of doxorubicin, known as ThermoDox®.
The expanded EAP is based, in part, on data from Celsion's Phase
III HEAT study of ThermoDox® in HCC. As of July 15, 2015, the latest overall survival (OS)
analysis demonstrated that in a large, well bounded, subgroup of
patients (n=285, 41% of the HEAT study patients), the combination
of ThermoDox® and optimized RFA provided a 58% improvement in OS
compared to optimized RFA alone. The Hazard Ratio at this analysis
is 0.63 (95% CI 0.43 - 0.93) with a p-value of 0.0198. Median
Overall Survival for the ThermoDox® group has been reached which
translates into a 25.4 month (2.1 year) survival benefit over the
optimized RFA only group (79 months for the ThermoDox® plus
optimized RFA group versus 53.6 months for the optimized RFA only
group).
"The survival data from the large subgroup of patients in our
HEAT study provides strong support for the expansion of the LTLD
EAP into this patient population that has limited treatment
options," stated Dr. Nicolas Borys,
Celsion's senior vice president and chief medical officer.
"We will be working closely with myTomorrows to set up the EAP in
this indication."
EAPs allow biopharmaceutical companies to provide eligible
patients with ethical access to investigational medicines for unmet
medical needs within the scope of the existing early access
legislation. Access is provided in response to physician
requests in a fully compliant manner, where no alternative
treatment options are available to these patients. Celsion
will provide LTLD in the EU, Switzerland, Turkey and Israel through myTomorrows. The Company
expects to have LTLD available for HCC in the second half of
2015.
"This expansion of our EAP in liver cancer reflects our
commitment to provide access to patients in desperate need of new
treatment options," said Michael H.
Tardugno, Celsion's chairman, president and chief executive
officer. "We have been pleased with establishing our Early Access
Program in RCW breast cancer, and look forward to being able to
provide expanding access to patients with HCC and liver metastases
consistent with our goal of providing effective therapies which may
significantly prolong and improve the quality of life. In
parallel with this EAP, we are also continuing to focus on
enrolling patients in our global Phase III OPTIMA study in HCC
designed to support registration in key markets worldwide. We
have expanded our HCC clinical development footprint with the
addition of 17 clinical sites in Spain, Germany and Italy."
About LTLD
Lyso-Thermosensitive Liposomal Doxorubicin (LTLD) is a
proprietary heat-activated liposomal encapsulation of doxorubicin,
an approved and frequently used oncology drug for the treatment of
a wide range of cancers. LTLD is being evaluated in a Phase III
clinical trial for primary liver cancer and a Phase II clinical
trial for recurrent chest wall breast cancer. Localized mild
hyperthermia (39.5 - 42 degrees Celsius) releases the entrapped
doxorubicin from the liposome. This delivery technology
enables high concentrations of doxorubicin to be deposited
preferentially in a targeted tumor.
About myTomorrows
myTomorrows is an online patient platform that is creating
freedom of choice for patients with unmet medical needs by offering
earlier access to medicines that show promising results during
clinical trials, but are not officially registered yet. With the
support of their doctors, patients who suffer from cancer, a
neurological disorder, a rare disease or a severe depression, can
have earlier access to such medicines. For more information about
myTomorrows, please visit the website www.mytomorrows.com.
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 and
Phase II for the treatment of recurrent chest wall breast cancer.
The pipeline also includes GEN-1, 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
Celsion Media Contacts
Harriet Shelare
Director, Communications
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation