Instylla first-in-human clinical trial published results demonstrate success


instyllaA prospective multicentre study has evaluated the safety and efficacy of a polyethylene glycol (PEG)-based liquid embolic in treating hypervascular tumours, according to an Instylla press release.

Instylla recently announced the publication of results from the first-in-human (FIH) clinical trial of the Embrace hydrogel embolic system (HES) for the treatment of hypervascular tumours, in the Journal of Vascular and Interventional Radiology (JVIR). This prospective, single-arm multicentre study demonstrated that Embrace HES effectively embolized malignant and benign hypervascular tumours by blocking tumour blood supply with technical success and persistent embolization, as noted in imaging follow-up at 30-days, in all eight patients treated on this study.

“This phase I first-in-human study of Embrace HES in the embolization of a range of hypervascular tumours has shown promising results,” commented Gerard Goh (The Alfred Hospital and Monash University, Melbourne, Australia), lead author on the study. “Embrace HES holds great potential with its ease of use, technical success in all patients, and no tumour revascularisation in the 30-day follow-up imaging.”

Ten embolizations were performed in eight patients with a range of tumour types, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and angiomyolipoma (AML). Tumour sizes ranged from 2.1–7.5cm and were treated with Embrace HES volumes from 0.4 to 4.0ml, with an average delivery time of 15 minutes.

Jee-Fu Huang (Kaohsiung Medical University Hospital, Kaohsiung, Taiwan) added, “Taiwan has one of the highest age-adjusted incident rates of HCC in East Asia, which is also the second leading cause of cancer-related deaths. This novel liquid embolic, designed to achieve capillary-level embolization, had favourable patient outcomes in the FIH trial, including HCC tumours. We are encouraged by these results. Our centre is currently enrolling in the Instylla HES HVT pivotal study, so I look forward to continuing to assess Embrace HES in treating hypervascular tumours.”


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