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Celsion Corporation Initiates Development Program for Glioblastoma Brain Tumors with ThermoDox® and HIFU



   Celsion Corporation Initiates Development Program for Glioblastoma Brain
                       Tumors with ThermoDox® and HIFU

Preclinical Studies Initiated at Brigham and Women's Hospital, Harvard Medical
School

PR Newswire

LAWRENCEVILLE, N.J., Jan. 21, 2014

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

Website: http://www.celsion.com
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