Royal Philips Electronics and Celsion announced that the U.S. Food and Drug Administration (FDA) has cleared the initiation of a clinical study supporting a joint development program in MR-guided high-intensity-focused ultrasound (MR-HIFU) technology.
The phase II study will combine Celsion's ThermoDox pharmaceutical with Philips' Sonalleve MR-HIFU technology for the palliation of painful bone metastases caused by lung, prostate, or breast cancers. The companies expect to begin the study in the second half of 2012.
Philips' MR-HIFU system is intended to target lesions with acoustic energy, creating sufficient heat to activate the ThermoDox agent and release high concentrations of doxorubicin in the targeted treatment area. ThermoDox is a heat-activated liposomal encapsulation of doxorubicin, according to the firms.
Celsion is developing the combination of ThermoDox and MR-HIFU through a joint research agreement with Philips Healthcare, a division of Royal Philips Electronics. Sonalleve MR-HIFU is commercially available in Europe for the treatment of uterine fibroids; it is not available for sale in the U.S., Royal Philips Electronics said.
