Celsion GmbH, a wholly-owned auxiliary of Celsion Corporation (NASDAQ: CLSN), commences enrollment in Phase I PanDox clinical trial using ThermoDox and FUS (Focused Ultrasound) patients to cure pancreatic cancer.
MHRA gives the nod for clinical trial
The oxford university-sponsored investigator-led clinical trial supported by NIHR (National Institute for Health Research) received the nod of institutional R&D and MHRA to begin PANDOX.
PANDOX is a multidisciplinary collaboration between Oxford University Institute of Biomedical Engineering, Celsion, the Oxford University Hospitals NHS Foundation Trust, and OCTO (Oncology Clinical Trials Office).
Mark Middleton will act as CCI (Chief Clinical Investigator), whereas Constantin Coussios works as the SI (Scientific Investigator) for the clinical trial.
The primary objective of the two-arm and 18 patients PANDOX clinical trial is an improved uptake of doxorubicin to cure pancreatic tumors with the help of FUS and Thermodox.
Administers Thermodox in twelve subjects
The heat-activated liposomal doxorubicin – Thermodox is given intravenously to twelve subjects with non-resectable PDAC (pancreatic ductal adenocarcinoma) and activated locally by FUS mediated hyperthermia.
Celsion will compare the data obtained from this clinical trial with conventional systemic administration of doxorubicin in six patients without FUS.
The company will compare the radiologically evaluated tumor activity/ response with FUS and Thermodox to the drug alone in the secondary endpoint.
It will assess the impact of FUS and Thermodox on patient symptoms. The team will also evaluate the safety profile of both ThermoDox and FUS.
The company expects to complete PANDOX clinical trial by the end of 2022. It is similar to TARDOX clinical trial involving ten patients.
TARDOX clinical trial results are available in Radiology and Lancet Oncology. In addition, the results of the preclinical trials conducted at the University of Washington demonstrated compelling results. Thermodox and FUS showed improved localized concentration and nuclear uptake of doxorubicin 23 times in those studies.
According to Laura Spiers, the survival rate of pancreatic cancer is less than 10%. In addition, the treatments using drugs are less effective compared to other cancers.
Therefore, finding innovative ways of administering high concentrations of anti-cancer drugs like doxorubicin would lead to a breakthrough in treating cancer and extending the patients’ survival rate.