Philips and Celsion Receive FDA Clearance for Phase II Study of Bone Cancer Device

Royal Philips Electronics and Celsion Corp. have announced they have received FDA clearance for the next phase of a joint development program of technology for the palliation of painful metastases to the bone caused by certain cancers, according to a news release.

 

The companies expect to initiate a Phase II study of Celsion's ThermoDox combined with Philips' Sonalleve MR-HIFU (MR-guided high intensity focused ultrasound) in the second half of 2012. The technology is intended to help treat pain associated with lung, prostate or breast cancers.

 

Philips' MR-HIFU system is designed to target lesions with acoustic energy. This would create sufficient heat to activate ThermoDox and release high concentrations of doxorubicin in the targeted treatment area, according to the companies.

 

Celsion is developing the combination of ThermoDox and MR-HIFU through a joint research agreement with Philips Healthcare, a division of Royal Philips Electronics.

 

"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," said Falko Busse, vice president and general manager, MR therapy for Philips Healthcare, in the release. "This multi-modality approach could be transformative for the treatment of a number of cancers. We remain excited about our collaboration with Celsion, and look forward to beginning the clinical study as soon as possible."

 

Royal Philips Electronics is headquartered in the Netherlands.

 

Celsion Corp. is headquartered in Lawrenceville, N.J.

 

Related Articles on FDA Clearances:

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