The US Food and Drug Administration (FDA) has granted clearance to Celsion and Royal Philips Electronics to commence a Phase II study of ThermoDox combined with Sonalleve MR-guided high intensity focused ultrasound (MR-HIFU) technology, designed to evaluate this multi-modality approach to pain palliation in patients with bone metastasis.

Celsion’s ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, while Philips’ Sonalleve MR-HIFU system is a heat-based therapy used for relieving pain associated with bone metastasis as well as treating uterine fibroids.

By using acoustic energy, Philips’ MR-HIFU system non-invasively targets lesions and creates sufficient heat to activate ThermoDox and release high concentrations of doxorubicin in the targeted treatment area.

Philips Healthcare MR therapy vice president and general manager Falko Busse said, "The combination of Philips’ MR-HIFU system, a high-precision, heat-based therapy, and ThermoDox, a heat-triggered oncolytic agent, holds great potential in that it gives us the ability to combine non-invasive thermal treatment with local delivery of high concentrations of potent, well-characterized anti-cancer drugs directly in a target area."

Celsion president and chief executive officer Michael H Tardugno said the company will evaluate ThermoDox in combination with MR-HIFU as a next generation, non-invasive treatment for lung, prostate or breast cancers.

"FDA’s clearance to clinically study the combination of ThermoDox and MR-HIFU is a cornerstone of this joint Celsion/Philips effort," Mr Tardugno added.

"As a recognized world leader in health care technology, Philips brings tremendous resources to this development pathway for ThermoDox, optimizing its role in cutting edge medicine."

The Phase II study is expected to be initiated in the second half of 2012.