Celsion Corporation, a leading oncology drug development company, announced that its ongoing collaboration with Dr. Costas Arvanitis of Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School, has been expanded through the recent award of a $1 million Career Development Award from the National Institutes of Health's Center for Biomedical Imaging and Bioengineering (NIBIB).

The grant will support preclinical studies evaluating ThermoDox, the company's heat-activated liposomal encapsulation of doxorubicin, in combination with High Intensity Focused Ultrasound (HIFU), for the treatment of brain tumours.  The grant, titled "Controlled Delivery and Release of Chemotherapy in Brain Tumours with FUS" provides on average of $200,000 in annual funding for five years, and will be used to advance preclinical development of ThermoDox for the treatment of brain cancers, including GBM, under the company's January 2014 collaboration with Brigham and Women's Hospital, Harvard Medical School.

"This peer-reviewed grant award builds upon our ongoing collaborative work to explore treatments for brain tumours," said Costas D. Arvanitis, Ph.D., Brigham and Women's Hospital, Harvard Medical School. "Delivering chemotherapeutic agents across the blood-brain barrier is particularly challenging, but in recent years we have discovered that this could be achieved using focused ultrasound, including enhanced delivery of liposomal doxorubicin.  We are hopeful that this grant will allow us to determine the potential utility of a promising therapeutic application for one of the most insidious cancers - glioblastoma."

"Glioblastoma is a highly aggressive and deadly form of brain cancer for which there are few treatment options," said Michael H. Tardugno, Celsion's President and CEO.  "Working with a prominent cancer research group like Dr. Arvanitis and his team, combined with the financial support of the NIH, will help accelerate the research required to elucidate the potential of ThermoDox combined with HIFU in this difficult to treat cancer, and provide a path forward for larger, more comprehensive phase II studies."

If promising results are obtained from these phase I studies, a phase II grant application will be submitted to include more comprehensive studies of ThermoDox and HIFU for the treatment of GBM brain tumours.

Glioblastoma multiforme (GBM), WHO classification name "glioblastoma", is the most common and most aggressive malignant primary brain tumor in humans, involving glial cells and accounting for over 50% of all functional tissue brain tumor cases and nearly 20% of all intracranial tumors.  In 2013, projected US incidence of brain tumors approaches 23,000 cases, with projected mortality at 14,000 cases. Treatment can involve chemotherapy, radiation and surgery. Median survival with standard-of-care radiation and chemotherapy is normally 15 months, and median survival without treatment is approximately 4½ months.

ThermoDox is a proprietary, heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers.  ThermoDox is being evaluated in a phase III clinical trial for primary liver cancer and a phase II clinical trial for recurrent chest wall breast cancer.  Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by radiofrequency ablation (RFA) releases the entrapped doxorubicin from the liposome.  This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumour.

Celsion is fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies.