LAWRENCEVILLE, N.J.,
Jan. 21, 2014 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN), a leading oncology drug development
company, announced today that the company is formalizing a program
to pursue the development of ThermoDox® to investigate applications
for treating brain cancer tumors, notably Glioblastoma Multiforme
or GBM. In addition to jointly submitting multiple grant
applications, the company is also pursuing preclinical studies in
collaboration with Dr. Costas D. Arvanitis at the Brigham and
Women's Hospital and Harvard Medical School. Experiments will
study the use of ThermoDox in combination with MR guided High
Intensity Focused Ultrasound (HIFU) to treat brain tumors,
initially in animal models.
"Brain cancer tumors represent a very high unmet medical need,
and researchers have been pursuing applications with HIFU for many
years," said Nicholas Borys, MD,
Celsion's Chief Medical Officer. "We are excited to
investigate the addition of ThermoDox, our heat-activated liposomal
encapsulation of doxorubicin, which could provide some clinical
benefit for a population that desperately needs more
applications."
Dr. Arvanitis, research fellow at Brigham and Women's Hospital
and Harvard Medical School stated, "We
have investigated the use of MR-guided focused ultrasound to treat
brain tumors for many years and have identified the need for drugs
that will improve our ability to treat brain tumors. We are excited
about this drug design, which is positioned to work with heat and
specifically HIFU, and its potential to cross the blood-brain
barrier and potentially demonstrate drug concentration in ways that
other drugs cannot. We are grateful for Celsion's support in this
research and look forward to pursuing this initial, pre-clinical
research with the hope of bringing this application to the clinic
in the future."
About Glioblastoma Multiforme (GBM) Brain
Tumors
Glioblastoma multiforme (GBM), WHO classification name
"glioblastoma", is the most common and most aggressive malignant
primary brain tumor in humans, involving glial cells and accounting
for over 50% of all functional tissue brain tumor cases and nearly
20% of all intracranial tumors. In 2013, projected US
incidence of brain tumors approaches 23,000 cases, with projected
mortality at 14,000. Treatment can involve chemotherapy, radiation
and surgery. Median survival with standard-of-care radiation and
chemotherapy is normally 15 months, and Median survival
without treatment is approximately 4½ months.
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. In the
HEAT Study, ThermoDox® is administered intravenously in combination
with RFA. Localized mild hyperthermia (39.5 - 42 degrees Celsius)
created by the RFA releases the entrapped doxorubicin from the
liposome. This delivery technology enables high concentrations of
doxorubicin to be deposited preferentially in a targeted tumor.
For primary liver cancer, ThermoDox® is being evaluated in a 701
patient global Phase III study at 79 clinical sites under an FDA
Special Protocol Assessment. The study is designed to evaluate the
efficacy of ThermoDox® in combination with RFA when compared to
patients who receive RFA alone as the control. On January 31, 2013, Celsion announced that
ThermoDox® in combination with RFA did not meet the primary
endpoint of the HEAT study in patients with hepatocellular
carcinoma, also known as primary liver cancer. Celsion has
conducted a comprehensive analysis of the data from the Phase III
HEAT Study with key principal investigators, data experts and liver
cancer experts. Emerging data from the HEAT Study post hoc
analysis demonstrates that ThermoDox® markedly improves PFS and
overall survival in patients if their lesions undergo RFA for 45
minutes or more. These findings apply to HCC lesions from
both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and
represent a sizable subgroup of approximately 300 patients.
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 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; termination of the Technology Development Contract or
collaboration between Celsion and HISUN at any time; 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