Celsion (CLSN) Announces Publication of ThermoDox Study Results in Radiology

January 17, 2019 8:32 AM EST
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Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced that results from the Phase I TARDOX trial of ThermoDox® conducted at the University of Oxford, United Kingdom, were published in the peer-reviewed journal, Radiology. The TARDOX trial evaluated the safety and efficacy of ThermoDox®, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin, along with focused ultrasound for the treatment of liver cancer. The article, titled, “Focused Ultrasound Hyperthermia for Targeted Drug Release from Thermosensitive Liposomes: Results from a Phase I Trial,” included an evaluation of the TARDOX results and the safety, efficacy and utility of treatment with ThermoDox® plus targeted, non-invasive hyperthermic ultrasound in patients with solid liver tumors, with treatment plans based on patient-specific modeling.

“The findings published in Radiology serve as a companion paper to the groundbreaking work published by Lyons et al in Lancet Oncology in July 2018. This work by the TARDOX team at the Oxford University Institute of Biomedical Engineering clearly demonstrated the local activity of ThermoDox® in liver cancer. This is the first published study to evaluate ThermoDox® as an effective therapeutic when combined with high-intensity focused ultrasound (HIFU). The Radiology paper is also accompanied by an editorial which highlights the significance of utilizing HIFU and ThermoDox®. Namely, that high concentrations of important drugs such as doxorubicin – through ThermoDox - can be delivered locally and effectively,” said Nicholas Borys, M.D., Celsion's senior vice president and chief medical officer.“ While further studies are warranted, the medical community has advocated for the use of ThermoDox® with focused ultrasound for some time, and these observations support the potential for focused ultrasound to expand the use of ThermoDox® to the treatment of other types of cancer.”

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. The Phase I TARDOX study demonstrated that focused ultrasound exposure with ThermoDox® resulted in increased chemotherapy concentrations within liver tumors that were an average of 3.7 times greater than preheating levels across all 10 patients in the study.

“This latest publication of ThermoDox® clinical data emphasizes the significance and utility of its thermally activated delivery system and the high level of interest and support from the medical community for improved, targeted delivery of therapeutically potent levels of chemotherapy in patients with primary liver cancer, and potentially other cancers. Consistent with the US National Institutes of Health’s findings, Oxford’s clinical results add to the independent evidence of ThermoDox®’s unique and potent anti-cancer mechanism of action,” said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. “Moreover, the positive findings from the TARDOX study showed the viability of focused ultrasound to deliver potent levels of doxorubicin with ThermoDox®, suggesting that ThermoDox® could also be successful when used in combination with other heating mechanisms, beyond radiofrequency ablation (RFA). This highly reassuring research fully supports our robust clinical development program for ThermoDox® in combination with RFA. We are looking forward to the first of two planned interim efficacy analyses from our ongoing Phase III OPTIMA study in 556 patients in mid-2019.”

The Phase I TARDOX study evaluated patients with inoperable primary or secondary liver tumors who had previously received chemotherapy. In this trial, 10 patients received a single intravenous dose of 50 mg/m2 of ThermoDox®, and ultrasonic heating of target tumors was monitored in six participants using a minimally invasive temperature sensor, while four patients were treated without real-time thermometry. Safety was assessed by analysis of magnetic resonance imaging (MRI) and biopsy specimens for evidence of thermal ablation, as well as adverse event monitoring. There was no evidence of focused ultrasound-related adverse effects, including thermal ablation.

Numerous studies have demonstrated that focused ultrasound can be used to generate mild heating to facilitate the release of drug cargoes from thermosensitive liposomes (TSLs). We believe the TARDOX study is the world’s first Phase I clinical trial aimed at evaluating the effect of doxorubicin released from TSLs after focused ultrasound–induced mild hyperthermia. The study presents a model for predicting the focused ultrasound treatment parameters needed to attain mild hyperthermia and facilitate doxorubicin release from TSLs. This model may improve the current clinical use of hyperthermia by providing an alternative strategy for treatment planning based on a thermal model rather than actual thermometry, which is more invasive.

For all participants, CT images were used with the patient-specific hyperthermia model in order to define focused ultrasound treatment plans. Feasibility was assessed by comparing model-prescribed focused ultrasound powers to those implemented for treatment. The mean difference between predicted and implemented treatment powers was -0.1 W ± 17.7 SD. We believe this is a meaningful initial demonstration of the model providing accurate, successful treatment parameters. In addition, these observations support the potential for non-invasive hyperthermic ultrasound to expand the use of ThermoDox® to the treatment of other types of cancer.

The TARDOX study was carried out as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering, the Oncology Clinical Trials Office (OCTO) and the Oxford University Hospitals NHS Foundation Trust.

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