Principal Investigator Professor Riccardo Lencioni Presents Celsion ThermoDox® Trial Data at SPECTRUM 2020 Interventional Oncology Conference
Company reaffirms its projection for second pre-planned interim efficacy analysis for Phase III OPTIMA Study in the second quarter of 2020
“The significant attention ThermoDox® is receiving among key opinion leaders at important medical conferences has helped build awareness of our drug in combination with RFA for treating HCC,” said
The Company’s OPTIMA Study was based on the prospective analysis of the HEAT Study subgroup of patients who received 45 minutes or more of RFA energy. The OPTIMA Study was fully enrolled in
The Company re-affirms its projection that its second pre-planned interim efficacy analysis will occur during the second quarter of 2020, following 158 patient events, or deaths. The hazard ratio for success at 158 events is 0.70, which is below the hazard ratio of 0.65 observed for the 285 patients in the HEAT Study subgroup of patients treated with RFA of 45 minutes or longer.
Mr. Tardugno added, “We were pleased that the HCC part of the SPECTRUM program featured invited faculty with ties to
The annual SPECTRUM conference offers attendees a comprehensive review of a variety of oncological diseases, combined with the latest developments in medical, interventional and surgical therapeutic options across multiple disciplines. A practical overview of how to incorporate emerging therapies into practice is presented through a multidisciplinary lens, intended to achieve the highest levels of success in the fight against cancer.
Celsion’s most advanced program is a heat-mediated 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. ThermoDox® is positioned for use with multiple heating technologies and has the potential to treat a broad range of cancers including metastatic liver, recurrent chest wall breast cancer and non-muscle invading bladder cancers.
Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, 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, ThermoDox® is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and 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 damages only the tumor and the area subject to tumor invasion, supporting more precise drug targeting.
About Celsion Corporation
Forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant;
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Source: Celsion CORP