LAWRENCEVILLE, NJ and CHARLOTTESVILLE, VA, May 01, 2012 (MARKETWIRE via COMTEX)
Celsion Corporation and the Focused Ultrasound
Foundation announced today their support for preclinical studies
designed to explore the use of ThermoDox(R), Celsion’s Phase III,
proprietary, heat-activated liposomal encapsulation of doxorubicin,
in combination with MR-guided high intensity focused ultrasound
(HIFU) for the treatment of pancreatic cancer. The studies are being
conducted at the University of Washington School of Medicine by Joo
Ha Hwang, M.D., Ph.D., Director, Endoscopic Research, Associate
Professor of Medicine and Adjunct Associate Professor of
Bioengineering and Radiology.
Celsion is supporting Dr. Hwang’s research with ThermoDox(R)
supplies, and the Foundation is funding the preclinical study,
“MR-guided HIFU Enhanced Targeted Drug Delivery for Treatment of
Pancreatic Cancer.”
A healthcare research and advocacy organization, the Focused
Ultrasound Foundation solicits research proposals to address areas of
unmet medical needs where HIFU may provide benefit. Before awarding
funding to Dr. Hwang, the Foundation had identified pancreatic and
liver cancers as potential clinical applications for HIFU and
designed a research roadmap to address a set of preclinical,
mechanistic and technical questions for the development of these
applications.
“We are excited about Dr. Hwang’s research and the new treatments he
is pioneering. As always, our goal is to save and improve lives by
supporting the development of new focused ultrasound therapies for
many of today’s most deadly and debilitating conditions,” said Arik
Hananel, M.D., Scientific and Medical Director of the Focused
Ultrasound Foundation.
The University of Washington School of Medicine research is expected
to include in vitro experiments to confirm the ability of HIFU to
target high concentrations of doxorubicin in proprietary pancreatic
cancer cell lines, and in vivo studies to assess the response to
these tumors treated using ThermoDox(R) with and without HIFU-induced
hyperthermia. The optimal HIFU exposure duration needed to maximize
doxorubicin concentration will also be evaluated, where ThermoDox(R)
will be compared against other chemotherapeutic agents used in
combination with HIFU in mouse tumor models.
“Focused ultrasound has the potential to make an enormous impact on
the treatment of pancreatic cancer, both as a means of ablating
tumors and for the enhancement of therapeutic drug delivery to these
tumors,” said Dr. Hwang. “The thermal drug targeting capability of
ThermoDox makes it the ideal candidate for a combination treatment
approach, one drawing from the benefits of both treatment modalities
to provide what may be an innovative option for this large and urgent
unmet medical need. I look forward to studying the combination in a
unique animal model, one which effectively recapitulates the human
disease, then moving rapidly into the clinic.”
“We are pleased and excited to support Dr. Hwang’s research and to
study ThermoDox’s potential in a disease with a staggering rate of
mortality and few treatment options,” said Michael H. Tardugno,
Celsion’s President and Chief Executive Officer. “In preclinical
models, ThermoDox combined with HIFU has already demonstrated strong
proof of concept, rationale and support for clinical studies in
certain cancers, including bone cancer. This further illustrates
ThermoDox’s broad potential to enhance the benefit of multiple
heat-based therapies, including HIFU and radiofrequency ablation,
across a spectrum of cancers.”
Through a joint research agreement, Celsion is also working with
Philips Healthcare, a division of Royal Philips Electronics, to
develop treatments for bone cancer using ThermoDox(R) and HIFU.
About Pancreatic Cancer
According to the American Cancer Society, in 2011, an estimated
44,030 Americans were diagnosed with pancreatic cancer in the U.S.,
and over 37,660 died from the disease. Pancreatic cancer is the 4th
leading cause of cancer-related death in the United States, with the
highest mortality rate of all major cancers and a five year survival
rate of only 6%. Pancreatic cancer is one of the few cancers for
which survival has not improved substantially over nearly 40 years.
About ThermoDox(R)
ThermoDox(R) 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. Localized mild hyperthermia
(39.5 – 42 degrees Celsius) created by focused heat energy 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(R) is being evaluated in a 700
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(R) in combination with radio frequency ablation
(RFA) when compared to patients who receive RFA alone as the control.
The primary endpoint for the study is progression-free survival (PFS)
with a secondary confirmatory endpoint of overall survival.
Additional information on the Company’s ThermoDox(R) clinical studies
may be found at
www.clinicaltrials.gov .
About Focused Ultrasound
An early-stage medical technology with the potential to revolutionize
the treatment of many life threatening and disabling conditions,
focused ultrasound uses concentrated acoustic energy to treat tissue
deep in the body while leaving surrounding healthy areas intact.
Potentially, focused ultrasound could be a breakthrough in
noninvasive surgery, serve as an alternative or complement to
radiation therapy and enable the delivery of chemotherapeutics and
other drugs at higher concentrations to precise targets with less
toxicity. Researchers around the world are investigating the
technology’s use in treating many forms of cancer — including bone,
brain, breast, liver, pancreas, prostate and thyroid — and
neurological conditions such as essential tremor, Parkinson’s
disease, epilepsy, obsessive compulsive disorder and stroke. In the
United States, focused ultrasound treatment for uterine fibroids has
been approved by the FDA. Other approved treatments are available
abroad.
About The Focused Ultrasound Foundation
Based in Charlottesville, Virginia, the Focused Ultrasound Foundation
was created to improve the lives of millions of people worldwide by
accelerating the development and adoption of focused ultrasound
therapies. The Foundation works to clear the path to global adoption
of these therapies by coordinating and funding research and
educational activities, creating partnerships and fostering
collaboration among stakeholders, and building awareness of
“medicine’s best kept secret.” The Foundation is dedicated to
ensuring that focused ultrasound finds its place as a mainstream
therapy for cancer, brain tumors, Parkinson’s disease, epilepsy,
stroke and other life-threatening conditions within years, not
decades. Since its establishment in 2006, the Foundation has become
the largest non-governmental source of funding for focused ultrasound
research.
The Foundation is supporting clinical studies in essential tremor and
brain tumors, as well as pending clinical trials for Parkinson’s
disease, breast cancer and epilepsy. Complete information about the
Foundation and its work can be found online at
www.fusfoundation.org .
About Celsion Corporation
Celsion is a leading oncology company 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, Kyungpook National University Hospital and
the Beijing Cancer Hospital. For more information on Celsion, visit
our website:
https://www.celsion.com .
Celsion Contact
David Pitts
Argot Partners
212-600-1902
Email Contact
Focused Ultrasound Foundation Contact
Ellen McKenna
Director of Communications
434-326-9827
Email Contact
SOURCE Celsion Corporation
