In a major development, Celsion Corporation and Philips Healthcare have requested FDA permission to launch U.S. clinical studies of a new focal drug delivery treatment for metastatic bone cancer. The method uses Celsion’s ThermoDox – a heat-sensitive liposomal encapsulation of the proven and widely used cancer drug, doxorubicin – and Philips’ MR-guided focused ultrasound technology.
Celsion is developing the combination of ThermoDox and high intensity focused ultrasound (HIFU) through a joint research agreement with Philips Healthcare, a division of Royal Philips Electronics.
In the FDA filing, the companies provided preclinical data published in the March 2011 issue of the International Journal of Hyperthermia. Robert Staruch, a Ph.D. candidate at the Centre for Research in Image-Guided Therapeutics at Sunnybrook Health Sciences Centre in Toronto, Canada, is the lead author of the article, which is entitled, "Localized drug release using MRI-controlled focused ultrasound."
Study data is also scheduled for presentation at the April 11-13 meeting of the International Society of Therapeutic Ultrasound (ISTU) in New York, NY and the April 29 - May 2 meeting of the Society of Thermal Medicine (STM) in New Orleans, LA.
According to Celsion’s President and Chief Executive Officer Michael H. Tardugno, "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. 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.”
Tardugno said the data is based on studies conducted at leading research centers in the U.S., Canada and Europe. “These results provide further support for our continued investment in expanding the oncology indications that can be addressed by ThermoDox," he added.
Nicholas Borys, M.D., Celsion’s Chief Medical Officer, 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."
Click here to read an in-depth profile of Celsion published in the FUS Foundation’s March 2010 newsletter.
Written by Ellen C., McKenna