LAWRENCEVILLE, N.J., 11 October 2016 – Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company, today announced a collaboration with the Children's Research Institute to conduct a clinical study of ThermoDox®, Celsion's heat activated liposomal encapsulation of doxorubicin, in combination with magnetic resonance-guided high intensity focused ultrasound (MR-HIFU) to treat relapsed or refractory solid tumors in children and young adults. This investigator-sponsored Phase I clinical study is being partially funded by the National Institutes of Health and is expected to commence in the fourth quarter of 2016.
"Even with the use of intensive therapy, the prognosis for children diagnosed with metastatic sarcoma and recurrent solid tumors remains poor and has not improved over the past three decades," stated Dr. Nicolas Borys, Celsion's chief medical officer. "Recent advances in the use of non-invasive MR-HIFU coupled with novel therapies such as ThermoDox® have demonstrated the clear potential to overcome the challenges to treating pediatric malignancies by enabling safer, more tolerable targeted therapies with the potential to change cancer treatment paradigms."
The trial targeting treatment of childhood sarcomas will be carried out as a multi-disciplinary collaboration among Celsion, the research groups of Dr. AeRang Kim, MD, PhD at the Children's National Medical Center - Department of Hematology/Oncology, and Dr. Brad Wood and Dr. Rosandra Kaplan at the National Institutes of Health.
"Celsion's experience in combining ThermoDox® with HIFU, a non-invasive next generation heating technology, supports this very important research in childhood cancers. From a safe dose, ThermoDox's proven ability to deliver high concentrations of an effective chemotherapy directly to a heated tumor makes it an ideal candidate for a trial involving children and young adults," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "This study will further define ThermoDox's potential in combination with ultrasound-induced hyperthermia, and highlight potential applications of ThermoDox® in combination with a broad range of heating technologies that could address an even larger population of patients."
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.
