COLUMBIA, Md., Oct. 19 /PRNewswire-FirstCall/ -- Celsion Corporation (Nasdaq: CLSN) announced today that two abstracts on the ThermoDox® High Intensity Focused Ultrasound (HIFU) development program have been delivered via oral presentation at the MR-guided Focused Ultrasound 2010 2nd International Symposium. The abstracts provide strong proof of concept, as well as the rationale and support for future clinical studies, which will combine ThermoDox with MR-guided HIFU for cancer indications. The symposium is being held October 17-20, 2010 at the Westfields Marriott in Dulles, VA .
The first abstract, titled "MR-guided High Intensity Focused Ultrasound Enhances Targeted Drug Delivery of Low Temperature Sensitive Liposomes in a Rabbit Vx2 Tumor Model," is authored by Ashish Ranjan from the National Institutes of Health, Bethesda, MD, USA. The second abstract, titled "Thermally-mediated Localized Drug Release Using MRI-Controlled Focused Ultrasound Hyperthermia," is authored by Robert Staruch from Sunnybrook Health Sciences Centre and University of Toronto, Canada. Additional co-authors from the two studies are from Duke University, University of Helsinki, Finland, and Philips Healthcare. The abstracts are available on the company's website site at www.celsion.com.
"We are delighted to expand our HIFU program to leading oncology research centers in the US, Canada and Europe," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "We hope to make a seamless transition to clinical studies in these and additional countries based on the preclinical data that has been developed through our joint research agreement with Philips Healthcare. Celsion and Philips are now well positioned to submit our clinical program for FDA review. Assuming we have agreement, we expect to commence trials in bone cancers next year."
Dr. Nicholas Borys, Chief Medical Officer at Celsion Corporation commented, "The ultrasound and radiology communities have been very supportive of targeted drug delivery applications using MR-guided HIFU. What started out as a few leading researchers in the US and Europe has now grown to a very large global research community. Similar to our Phase III HEAT study, we expect future HIFU clinical studies will include Asia Pacific, as many researchers from Korea, Taiwan, and China continue to approach us with new oncology applications using MR-guided HIFU."
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 including breast cancer. ThermoDox®, which is administered intravenously and in combination with hyperthermia, has the potential to provide local tumor control and improve quality of life. Localized mild hyperthermia (39.5-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
ThermoDox® has also demonstrated evidence of efficacy in a Phase I study for primary liver cancer. Celsion has been granted FDA Orphan Drug designation for ThermoDox® and is conducting a pivotal 600 patient global Phase III study in primary liver cancer under a FDA Special Protocol Assessment.
Additional information on ThermoDox® clinical studies for RCW breast cancer and primary liver cancer can be found at: www.clinicaltrials.gov.
ThermoDox® is a registered trademark of Celsion Corporation.
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has licensed ThermoDox® to Yakult-Honsha for the Japanese market and has a partnership agreement with Phillips Medical to jointly develop the Company's heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. 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, Cleveland Clinic, 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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