The ThermoDox and MR-HIFU program shows great promise for treating life-threatening cancers

Royal Philips Electronics (NYSE: PHG; AEX: PHI) and Celsion Corporation (NASDAQ: CLSN) today announced that their joint research program to evaluate ThermoDox® in combination with MR-HIFU (Magnetic Resonance guided High Intensity Focused Ultrasound) as a combination therapy to non-invasively treat difficult cancers has successfully completed the feasibility stage. The program has now moved into pre-clinical development and will focus on the combined use of ThermoDox® (Celsion’s heat-activated liposomal drug) and Philips’ MR-HIFU system for the treatment of pancreatic cancer and cancer metastases in bone.

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 the drug doxorubicin. This Celsion-Philips combinational treatment approach may change the paradigm for addressing a broad range of cancers.

Prominent experts in the field of MR-HIFU cancer treatment, including Dr. Bradford Wood of the National Institutes of Health Clinical Center, Dr. Chrit Moonen of the CNRS/University Victor Segalen Bordeaux, and Dr. Kullervo Hynynen of Sunnybrook Health Sciences Centre are participating in the Celsion-Philips research program. Under the leadership of Dr. Wood, these researchers will be conducting pre-clinical studies to assess doxorubicin drug delivery and to optimize MR-HIFU performance in this application. An IND (Investigational New Drug) submission is planned for early 2010, following successful completion of the pre-clinical studies.

The companies’ joint research is focused on the treatment of pancreatic cancer and cancer metastases in bone.

Pancreatic cancer is an aggressive cancer with an extremely high mortality rate. There are 37,000 annual incidences in the U.S., which ranks pancreatic cancer as the fourth leading cause of cancer deaths. Curative surgical resection (also known as the ‘Whipple’ procedure) is indicated in fewer than 20% of patients, while chemotherapeutic approaches provide modest, if any, patient survival benefit. These factors illustrate the high unmet need for better treatments and the potential significance of MR-HIFU mediated, targeted delivery of doxorubicin.

For bone metastases, ThermoDox® combined with MR-HIFU will be investigated both for tumor control as well as for palliative pain treatment. Cancer progresses to bone metastases in a majority of patients with late-stage breast, prostate or lung cancer, with estimates of between 300,000 – 500,000 cases annually in the U.S. Patients typically experience excruciating and unrelenting pain, often treated with opiate drugs and NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) with modest benefit. External beam radiation therapy has been used for tumor control, but does not provide significant pain relief for many patients.

“The drug/device combination of ThermoDox and MR-HIFU has great synergy with the potential to provide an innovative non-invasive therapy for patients with aggressive and life-threatening cancers,” said Falko Busse, vice president and general manager MR-HIFU for Philips Healthcare. “We are excited about our continued collaboration with Celsion because the combination of our technologies could provide a more effective treatment for pancreatic cancer and bone metastases.”

“Since the beginning of the collaboration in 2008, Philips and Celsion have made excellent progress to develop ThermoDox and MR-HIFU,” added Michael H. Tardugno, Celsion’s President and Chief Executive Officer. “Initial feasibility work suggests that a combination of these technologies has the potential to significantly expand the market for ThermoDox; providing promise to thousands of patients with difficult to treat disease.”