Celsion Announces Publication of Findings from Single-Site Study in China of ThermoDox® Plus RFA in the Journal of Cancer Research and Therapeutics
Data show overall survival improvement of 22.5 months with ThermoDox® plus RFA of 45 minutes or longer
Data provides additional corroboration of ThermoDox’s potential for
superior efficacy when combined with a well-executed RFA procedure
In this study, patients received 50 mg/m2 of ThermoDox® or placebo, plus RFA for 45 minutes or longer. Patients were followed for 11 to 80 months (average: 49.1 ± 24.8 months), with 18 of 22 patients completing the study. The mean OS for the ThermoDox® plus RFA group was 68.5 ± 7.2 months, which was significantly greater than the placebo plus RFA group (46.0 ± 10.6 months, pValue = 0.045). At the end of the follow-up period, the percentage of patients alive after 1, 3 and 5 years were as follows:
ThermoDox + RFA RFA Alone
% of patients alive at 1 year 90.0% 87.5%
% of patients alive at 3 years 90.0% 50.0%
% of patients alive at 5 years 77.1% 37.5%
The publication can be found in the
“Publication of Prof. Chen and colleagues’ positive findings in this peer-reviewed journal provides further proof-of-principal that ThermoDox®, in conjunction with 45 minutes or more of RFA, can have a significant positive impact on survival for certain patients with primary liver cancer,” said
“Although this was a study involving only one site as part of the Company’s Phase III HEAT Study, Prof. Chen’s results are compelling nonetheless, and support our prospective subgroup analysis of 285 patients that showed subjects receiving 45 minutes or more of RFA in combination with ThermoDox®, with a single lesion of 3-7 cm in size, had median overall survival of more than 7.5 years and an improvement over the control arm of more than 2 years. Moreover, these data, if duplicated in our Phase III OPTIMA Study, would result in a positive trial. We now eagerly await the results of the OPTIMA Study, with the first interim data analysis expected by the end of October, the design of which is based on this subgroup analysis from the HEAT Study,” added Mr. Tardugno.
“The authors concluded that RFA with heat target delivery chemotherapy facilitated better tumor coagulation necrosis without additional toxicity. This combined treatment may improve the clinical efficacy of RFA or free doxorubicin and prolong survival in patients with medium to large HCC,” said
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 of 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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