LAWRENCEVILLE, New Jersey,
Jan. 20, 2015 /PRNewswire/ -- Celsion
Corporation (NASDAQ:CLSN), a fully-integrated oncology company
focused on the development of a portfolio of innovative cancer
treatments, today announced that it has signed a license and
distribution agreement with myTomorrows to implement an Early
Access Program for ThermoDox®, its proprietary heat-activated
liposomal encapsulation of doxorubicin, in all countries of the
European Union (EU) territory plus Switzerland for the treatment of patients with
recurrent chest wall (RCW) breast cancer.
RCW breast cancer is difficult to treat and has a poor prognosis
with a significant impact on a patient's quality of life. Patients
with highly resistant tumors found on the chest wall often see
their cancer progress despite previous treatment attempts including
chemotherapy, radiation therapy and hormone therapy. There are
approximately 25,000 to 35,000 incidence of RCW breast cancer in
the EU alone and thermal therapy is a well-accepted strategy for
treating patients. Recent findings from two Phase I studies and an
ongoing open label Phase II study indicate that when combined with
thermal therapy, ThermoDox can demonstrate significant overall
response rates and tumor control in post mastectomy, refractory
patients.
Early Access Programs (EAP) 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 ThermoDox® to centers of excellence in the EU
and Switzerland through its Early
Access Program with myTomorrows, at prices that are comparable to
chemotherapeutics used to treat this and other aggressive form of
cancer. The Company expects to have ThermoDox® available for the
EAP in the second quarter of 2015.
"We are very excited to make ThermoDox® available to patients
with breast cancer who have few options once the tumors have
progressed to the chest wall. Patients with highly resistant tumors
found on the chest wall often see their cancer progress despite
treatment which typically involves chemotherapy, radiation therapy
and hormone therapy," stated Dr. Nicolas
Borys, Celsion's Senior Vice President and Chief Medical
Officer. "ThermoDox® coupled with mild hyperthermia therapy appears
to be active in these heavily pre-treated patients with RCW breast
cancer. I look forward to working with prescribing physicians and
myTomorrows to bring this promising and innovative medicine to the
European medical community."
"Celsion is honored and proud to be part of this important Early
Access Program that affects the lives of thousands of women each
year. This Early Access Program emphasizes our commitment to
addressing refractory RCW breast cancer and to providing patients
and their physicians with early access to our promising therapeutic
approach," said Michael H. Tardugno,
Celsion's Chairman, President and Chief Executive Officer. "In
addition to the Early Access Program, we are expanding our
development efforts in this indication and plan to initiate a
European-based Phase II clinical trial in RCW breast cancer
patients. Our common goal is to develop and provide the most
effective therapies to improve and prolong the quality of
life."
About ThermoDox®
ThermoDox® 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.
ThermoDox® 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
in Phase II development for the treatment of RCW 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
significant risks and uncertainties including, without limitation,
ThermoDox® is an investigational and not an approved drug,
unforeseen changes in the course of research and development
activities, in clinical trials, and the EAP; 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
+1-609-482-2455
jchurch@celsion.com