Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, has announced the enrollment of the first patients in the Embrace Hydrogel Embolic System (HES) global randomized clinical trial, a pivotal study to evaluate the use of novel liquid embolic versus standard of care in treating malignant and benign hypervascular tumors.
As demonstrated previously in the completed First-in-Human (FIH) study, Embrace HES was effective at embolizing malignant and benign hypervascular tumors by blocking tumor blood supply with complete technical success and persistent embolizationi as noted in imaging follow up at 30-days.
"I am pleased to be evaluating this new technology for hypervascular tumor embolization," commented Dr. Gerard Goh, Head of Interventional Radiology at The Alfred Hospital, Melbourne Australia, and President of the Interventional Radiology Society of Australasia (IRSA). "While participating in the First-in-Human study prior to this trial, Embrace showed great promise with good control, favorable patient outcomes, and no tumor revascularization. We are excited to be the first center to enroll in this global, randomized trial."
A hypervascular tumor, which can be found in the liver, kidney, or elsewhere, has an increased number of blood vessels relative to other tissues. These tumors are often associated with low survival rates.ii Due to the increased risk of bleeding, hypervascular tumors can be challenging to remove. Transcatheter arterial embolization (TAE) and transarterial chemoembolization (cTACE) are established treatments for hypervascular tumors, particularly for patients with limited progressive disease. Embrace HES, an investigational product, is a liquid embolic designed to deeply penetrate the tumor vascular bediii, solidify, and stop blood flow. The Embrace HES embolization uses no solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment. Its main components are water and polyethylene glycol (PEG). PEG has a long history of safe use in implantable medical devices.
"We are thrilled to be the first center in the US to treat a patient on this study. Embrace's predictability helps me embolize the tumor while avoiding non-target embolization," added Dr. Edgar D. St. Amour, Interventional Radiologist from CARTI Cancer Center in Little Rock. "I look forward to continued evaluation of this new advancement in treating hypervascular tumors."
"I would like to thank Drs. Goh and St. Amour, and our other global trial sites for their efforts and collaboration in achieving this significant clinical milestone," said Amar Sawhney, Instylla CEO. "Hypervascular tumors can cause significant morbidity and mortality. At Instylla, we are focused on creating novel solutions to improve outcomes for these patients."
i Manuscript submitted for publication
ii Hotta, Naoki & Ayada, Minoru & Okumura, Akihiko & Ishikawa, Tetsuya & Sato, Ken & Oohashi, Tomohiko & Hijikata, Yasutaka & Kakumu, Shinichi. (2009). Hepatocellular Carcinoma 11 and a Half Years after the Resolution of Chronic Hepatitis C Virus Infection Successfully Treated with Interferon. Case reports in gastroenterology. 3. 175-181. 10.1159/000225244.
iii Ganguli S, Lareau R, Jarrett T, Soulen MC, A Water-based Liquid Embolic: Evaluation of Safety and Efficacy in a Rabbit Kidney Model, Journal of Vascular and Interventional Radiology (2021)
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Instylla to Enroll Patients in Clinical Trial for Treatment of Hypervascular Tumors. Appl Radiol.