Drug developer Celsion and sufferers of primary liver cancer received some good news from the FDA this week as the Columbia, MD-based company's first drug, ThermoDox, was granted fast-track status.
Developed in partnership with Duke University, Celsion's technology involves low heat-activated liposomes, which the company says enables delivery of drugs directly to cancer sites. They call them lysolipid thermally sensitive liposomes (LTSL), and they're being billed by Celsion as "the first in a new generation of liposomes." ThermoDox, enhanced with LTSL, treats primary liver cancer and recurrent chest wall breast cancer.
The specially treated liposomes concentrate at the tumor as an external microwave device gently heats the tumor tissue to 42 degrees Celsius over the course of 40 minutes. ThermoDox circulates through the bloodstream, penetrating tumors through vascular leaks. The microwave heat accentuates this leaking, opening the tumor door to more ThermoDox. According to the company, the liposome "melts" only when the microwave heat is present and releases the oncology drug doxorubicin only into the tumor in high concentrations.
Celsion says its goal is to improve standard treatment options for difficult-to-treat cancers, including non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. For liver cancer, the technique is used in conjunction with radio frequency ablation (RFA), which uses uses extremely high temperatures of 80 to 100 degrees Celsius to ablate tumors. RFA may fail to treat the outer margins of larger tumors since temperatures in the periphery are not high enough to destroy the cancer cells. That's where ThermoDox comes in.
"We are very pleased to receive the Agency's Fast-Track Designation for ThermoDox," says CEO Michael Tardugno, in a statement. "Fast Track Designation is an acknowledgement that HCC is a significant unmet medical need representing a life threatening disorder. It also recognizes the challenges facing pharmaceutical companies to develop effective new treatments for this difficult disease."
ThermoDox is currently being evaluated under a Special Protocol Assessment agreement with the FDA in a 600-patient global Phase III trial in patients with primary liver cancer. Celsion hopes to complete patient enrollment by the end of the year.