News | August 13, 2012

FDA Clears Way for Phase II Study of ThermoDox and MR-Guided HIFU

Philips, Celsion collaborate on noninvasive, next-generation approach to palliation

August 13, 2012 — Royal Philips Electronics and Celsion Corp. announced that the U.S. Food and Drug Administration (FDA) has provided clearance to initiate a clinical study supporting a joint development program for Celsion’s ThermoDox combined with Philips' Sonalleve MR-HIFU (magnetic resonance-guided high intensity focused ultrasound) technology for the palliation of painful metastases to the bone caused by lung, prostate or breast cancers. The companies expect to initiate a phase II study in this indication in the second half of 2012.

ThermoDox combined with MR-HIFU will be investigated for pain palliation in patients with bone metastasis. Cancer progresses to the bone in a majority of patients with late-stage breast, prostate or lung cancer, with estimates of between 300,000 to 500,000 cases annually in the United States. Patients may experience excruciating and unrelenting pain, often treated with opiate drugs and NSAIDs (non-steroidal anti-inflammatory drugs) with only modest benefit. External beam radiation therapy is effective in palliating painful bone metastasis, but is limited by accumulating toxic effects to normal organs.

Philips’ MR-HIFU system has the potential to precisely and noninvasively target lesions with acoustic energy, creating sufficient heat to activate ThermoDox and preferentially release high concentrations of doxorubicin in the targeted treatment area. Celsion is developing the combination of ThermoDox and MR-HIFU through a joint research agreement with Philips Healthcare.

“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 noninvasive 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, Philips Healthcare. "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."

“Celsion is excited to evaluate ThermoDox in combination with MR-HIFU as a next-generation, noninvasive treatment for a variety of cancers. FDA’s clearance to clinically study the combination of ThermoDox and MR-HIFU is a cornerstone of this joint Celsion/Philips effort,” said Michael H. Tardugno, president and CEO of Celsion.

For more information: www.philips.com/sonalleye, www.celsion.com

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