News | Oncology Related Products | December 19, 2016

Phase I study will be first in U.S. to use ThermoDox in combination with noninvasive magnetic resonance-guided high-intensity focused ultrasound in children

MR-HIFU, ThermoDox, combination therapy, recurrent childhood tumors, Celsion, Children's National Health System, Phase I clinical study

December 19, 2016 — Children’s National Health System and Celsion Corp. announced in November the launch of a clinical study of the use of heat-activated chemotherapy drug ThermoDox in combination with noninvasive magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) to treat refractory or relapsed solid tumors in children and young adults.

The primary objective of the investigator-sponsored Phase I study, partially funded by a National Institutes of Health (NIH) R01 grant, is to determine a safe and tolerable dose of ThermoDox, a lyso-thermosensitive liposomal doxorubicin (LTLD), which can be administered in combination with MR-HIFU. Under the guidance of an MRI, the high-intensity focused ultrasound directs sound wave energy to heat the tumor and the area around the tumor. When heated, the liposome rapidly changes structure and releases doxorubicin directly into and around the targeted tumor.

“There is currently no known cure for many patients with refractory recurring solid tumors, despite the use of intensive therapy, so we need to identify new, smarter therapies that can improve outcomes,” said AeRang Kim, M.D., Ph.D., an oncologist and member of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National, and principal investigator for the study. “Recent advances in the use of noninvasive MR-HIFU coupled with novel therapies, such as LTLD, may provide us with a mechanism to noninvasively administer high concentrations of the drug directly to the site where it is most needed and avoid toxicity to other areas of the body.”

This is the first time LTLD is being combined with MR-HIFU and the first time it is being evaluated in children.

The study targeting the treatment of childhood sarcomas will be carried out as a multi-disciplinary collaboration between Children’s National, Celsion and an NIH team led by Bradford Wood, M.D.

This is the latest study from the Image-Guided Non-Invasive Therapeutic Energy (IGNITE) program, a collaboration of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and the pediatric health system’s Divisions of Radiology, Oncology, Surgery and Anesthesiology. The goal of the IGNITE program is to improve the quality of life and outcomes for pediatric patients through the development and clinical introduction of novel minimally invasive and noninvasive surgery technologies and combination therapy approaches. In 2015, doctors from Children’s National were the first in the U.S. to treat osteoid osteoma, a benign and painful bone tumor, using MR-HIFU.

ThermoDox is currently in late-stage clinical trials in primary liver cancer and recurrent chest wall breast cancer. It is positioned for use with multiple heating technologies, and has the potential for applications in the treatment of other forms of cancer including metastatic liver and non-muscle invading bladder cancers.

For more information: www.celsion.com

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