Celsion Announces Resubmission With Philips Healthcare of Combined IND/IDE Application for a Phase 2 Study of ThermoDox(R) and MR-Guided HIFU in Bone Cancer

Celsion Corporation CLSN today announced a joint resubmission with Philips Healthcare of an Investigational New Drug/Investigational Device Exemption (IND/IDE) application with the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of Celsion's ThermoDox® combined with Philips' Sonalleve® MR-HIFU (MR-guided high intensity focused ultrasound) technology for the treatment of prostate cancer metastases to the bone. The companies expect to initiate the clinical study as soon as possible following FDA acceptance of the proposed program. "Since we began our collaboration, both Celsion and Philips have understood the significant potential of combining ThermoDox® and HIFU," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Many thought leaders believe that a multimodality approach is critical to the effective treatment of a variety of cancers. ThermoDox®, as a 'drop-in' therapy triggered only in the presence of heat, offers the ideal complement to potentially extend the menu of HIFU-based treatments. We look forward to completing our IND/IDE submission and, as we approach the outcome of our pivotal Phase III HEAT Study of ThermoDox® in primary liver cancer later this year, to initiating this Phase 2 study in metastases to the bone." ThermoDox® combined with MR-HIFU will be investigated for pain palliation in patients with painful 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. "A non-radioactive single-treatment therapy that acts quickly and brings significant pain relief to these debilitated patients would be a substantial step forward in the palliation of bone pain," said Nicholas Borys, MD, Celsion's Chief Medical Officer.