CELSION ANNOUNCES PUBLICATION OF THERMODOX® PHASE I CLINICAL STUDY RESULTS IN THE LANCET ONCOLOGY
– The TARDOX Study, in Collaboration with
– Imaging Studies in Patients Treated with ThermoDox® and Focused Ultrasound Demonstrated Clinical Response After a Single Dose –
– Demonstrates in Actual Patients that Tumor Concentrations of Doxorubicin Increased up to 10-fold With Targeted Heating Using Focused Ultrasound –
“Reaching therapeutic levels of cancer drugs within a tumor, while avoiding side effects for the rest of the body is a challenge for all cancer drugs, including small molecules, antibodies and viruses,” said Professor
“The findings published in The Lancet Oncology prove that ThermoDox® combined with targeted thermal therapy can increase the concentration of doxorubicin up to 10 times in actual tumors in liver cancer patients,” said
A lysolipid thermally sensitive liposome encapsulating the chemotherapy agent, doxorubicin, ThermoDox® is designed to release targeted levels of doxorubicin into and around liver tumors with heat activation. In this Phase I study, and consistent with the ThermoDox® heat-activated design, the amount of drug passively reaching the tumor was low and estimated to be below therapeutic levels before ultrasound exposure. Following focused ultrasound application with ThermoDox®, chemotherapy concentrations within the liver tumor were between two and ten times higher in seven out of 10 patients, with an average increase of 3.7 times across all patients.
“Only low levels of chemotherapy entered the tumor passively. The combined thermal and mechanical effects of ultrasound not only significantly enhanced the amount of doxorubicin that entered the tumor, but also greatly improved its distribution, enabling increased intercalation of the drug with the DNA of cancer cells,” explained Dr.
The Phase I trial evaluated patients with inoperable primary or secondary liver tumors and who had previously received chemotherapy. The procedure was carried out under general anaesthesia, and patients received a single intravenous dose of 50 mg/m2 of ThermoDox®. The target tumor was selectively heated to over 39.5o C using an approved ultrasound-guided focused ultrasound device at the
“This study adds to the ever growing body of evidence supporting thermally activated ThermoDox® has the potential to deliver potent and concentrated levels of doxorubicin to liver tumors – an effect that we believe may result in enhanced tumor killing,” said
The TARDOX Study, supported by the
¹ For today’s news release issued by
Celsion’s most advanced program is a heat-mediated, tumor-targeting drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. In one of its most advanced applications, ThermoDox®, when combined with radiofrequency thermal ablation (RFA), has the potential to address a range of cancers. For example, RFA in combination with ThermoDox® has been shown to expand the “treatment zone” with a margin of highly concentrated chemotherapy when treating individual primary liver cancer lesions. The goal of this application is to significantly improve efficacy.
Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. The first: Rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, LTLD is engineered to allow significant accumulation of liposomes at the tumor site at the time of radiofrequency ablation as these liposomes recirculate in the blood stream. The second: When the tumor tissue is heated to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that release the chemotherapeutic agent directly into the tumor and into the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method targets only the tumor and the area related to tumor invasion, supporting precise drug targeting.
About the OPTIMA Study
The Phase III OPTIMA Study is expected to enroll up to 550 patients in up to 70 clinical sites in
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