Advertisement
News
Advertisement

University of Washington's Dr. Joo Ha Hwang to Conduct Proof of Concept Study

Tue, 05/01/2012 - 4:45am
The Associated Press

(http://www.celsion.com)

(http://www.fusfoundation.org)

Celsion Corporation (NASDAQ: CLSN) and the Focused Ultrasound

Foundation announced today their support for preclinical studies

designed to explore the use of ThermoDox@, 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@ 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@ with and without HIFU-induced

hyperthermia. The optimal HIFU exposure duration needed to maximize

doxorubicin concentration will also be evaluated, where ThermoDox@

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@ 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@

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. 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@ 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@ 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@ clinical studies may be found

at

www.clinicaltrials.gov(http://ctt.marketwire.com/?release=880697&id=1547101&type=1&url=http%3a%2f%2fwww.clinicaltrials.gov%2f).

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(http://ctt.marketwire.com/?release=880697&id=1547104&type=1&url=http%3a%2f%2fwww.fusfoundation.org%2f).

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:

http://www.celsion.com(http://ctt.marketwire.com/?release=880697&id=1547107&type=1&url=http%3a%2f%2fwww.celsion.com%2f).

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading