Phase 1 Trial Begins for New Treatment Delivery Strategy in Pancreatic Cancer

Celsion GmbH has initiated a phase 1 trial to analyze ThermoDox with focused ultrasound for patients with pancreatic cancer.

A phase 1 trial called PanDox has begun enrolling patients with pancreatic cancer to study ThermoDox when given in conjunction with Focused Ultrasound (FUS). ThermoDox is a heat-activated liposomal encapsulation of doxorubicin, created by Celsion Corporation – the biotechnology company launching the trial.

News that enrollment has begun was shared in early July, and the researchers expect to complete the study by December 2022. ThermoDox will be administered to 12 patients intravenously – all of whom have non-resectable pancreatic ductal adenocarcinoma (PDAC). It will then be locally activated by FUS-mediated hyperthermia. The trial will have two groups – one receiving the new treatment and the other receiving conventional systemic delivery of doxorubicin without FUS.

According to preclinical studies cited in a release, ThermoDox plus FUS increased localized concentration and nuclear uptake of doxorubicin 23-fold.

“Pancreatic cancer has a low five-year survival rate of approximately 10% and drug-based treatments remain less effective than in other cancers, in part due to the unique challenges presented by the stroma surrounding pancreatic tumors,” said Dr. Laura Spiers, lead oncology clinical research fellow on the PanDox study. “Therefore, finding innovative and effective means of delivering high concentrations of anti-cancer agents such as doxorubicin may lead to a breakthrough for this difficult-to-treat cancer.”

“The ultimate goal is to develop a cost-effective and scalable approach that can be rapidly deployed for the benefit of pancreatic cancer patients,” added Dr. Michael Gray, lead biomedical engineering research fellow.

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