COLUMBIA, MD--(Marketwire - March 01, 2011) - Celsion Corporation (NASDAQ: CLSN) announced today the publication of data highlighting the preclinical efficacy for ThermoDox® with High Intensity Focused Ultrasound (HIFU) as well as the presentation of related research abstracts at two upcoming medical conferences. The article, titled “Localized drug release using MRI-controlled focused ultrasound” by lead author Robert Staruch from Centre for Research in Image-Guided Therapeutics, Sunnybrook Health Sciences Centre, in Toronto, Canada, will be published in the March 2011 issue of the International Journal of Hyperthermia. The late-breaking abstracts will be presented at both the Annual Meetings of the Society of Thermal Medicine (STM) and International Society of Therapeutic Ultrasound (ISTU). The STM Annual Meeting will be held on April 29 - May 2, 2011 in New Orleans, LA, and the ISTU Annual Meeting will be held on April 11-13, 2011 in New York City.
The publication and abstracts establish proof of concept, rationale and support for future clinical studies combining ThermoDox® with MR-guided HIFU in the treatment of certain cancers. Celsion is developing the combination of ThermoDox® and HIFU through a joint research agreement with Philips Healthcare, a division of Royal Philips Electronics. Celsion and Philips have submitted their preclinical findings with a request to initiate a clinical program in metastatic bone cancer to the U.S. Food and Drug Administration. The companies expect to initiate clinical studies later in 2011.
“Our preclinical research has shown an impressive ability to concentrate doxorubicin in tissue heated by Philips’ non-invasive, MR-Guided HIFU technology, thus expanding the area of treatment in a targeted manner,” said Michael H. Tardugno, Celsion’s President and Chief Executive Officer. “The combination of ThermoDox® and HIFU is a very promising development pathway with the potential to fill a significant gap between surgery and systemic chemotherapies in the treatment of certain cancers. These studies, conducted at leading research centers in the U.S., Canada and Europe, provide further support for our continued investment in expanding the oncology indications that can be addressed by ThermoDox®.”
Dr. Nicholas Borys, Chief Medical Officer at Celsion Corporation, commented, “Both the academic and medical communities have been very supportive of targeted drug delivery applications using MR-guided HIFU. We are excited to enter the clinic later this year and treat patients with this innovative combination therapy.”
About Philips’ MRI Guided High Intensity Focused Ultrasound (MR-HIFU)
MRI-guided High Intensity Focused Ultrasound, or MR-HIFU, is a new non-invasive technique with the potential to provide local tumor control and improve quality of life. The Philips MR-HIFU system combines the HIFU capability of non-invasively heating tissue deep inside the human body with the excellent soft tissue contrast, 3D imaging capabilities, and non-invasive temperature measurement techniques provided by MRI to plan, guide and monitor the treatment.
The Philips MR-HIFU system offers a unique technique called Volumetric Heating. With this technique, essential for localized mild hyperthermia, the ultrasound focus is moved electronically over the volume to be heated and is monitored with real-time temperature sensitive MR images to create a uniform temperature distribution. For the treatment of uterine fibroids, a prevalent condition in women of childbearing age, the Philips MR-HIFU system is currently being evaluated in a global multi-center clinical trial involving centers in North America, Europe and Asia. For more information about Philips’ MR-HIFU email: mrhifu.info@philips.com.
About ThermoDox® and the Phase III HEAT Study
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 600 patient global Phase III study at 76 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. A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT Study is complete and 190 PFS events are realized in the study population. Additional information on the Company’s ThermoDox® clinical studies may be found at http://www.clinicaltrials.gov.
About Celsion
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 drug delivery systems. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Mayo Clinic, the University of Pisa, and the North Shore Long Island Jewish Health System.
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 by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission.
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