Royal Philips Electronics and Celsion Corporation have received the US FDA clearance to initiate a clinical study supporting a joint development programme for Celsion’s ThermoDox combined with Philips’ Sonalleve MR-guided high intensity focused ultrasound (MR-HIFU) 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 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 US. Patients may experience excruciating and unrelenting pain, often treated with opiate drugs and non-steroidal anti-inflammatory drugs (NSAIDs) 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 non-invasively 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, 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-characterised anti-cancer drugs directly in a target area,” said Falko Busse, VP and GM, MR Therapy for Philips Healthcare. This multi-modality approach could be transformative for the treatment of a number of cancers.
“Celsion is excited to evaluate ThermoDox in combination with MR-HIFU as a next generation, non-invasive treatment for a variety of cancers; a logical step to expand ThermoDox’s great potential in oncology. 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, Celsion’s President and CEO. “As a recognised world leader in health care technology, Philips brings tremendous resources to this development pathway for ThermoDox, optimising its role in cutting edge medicine.”
EH News Bureau