Advanced NanoTherapies—ANT—has announced the completion of a US$4million Series A extension from a prominent undisclosed strategic medical device company, alongside the successful treatment of the first cohort of study participants in its ADVANCE-DCB first-in-human (FIH) trial.
The trial is intended to demonstrate initial short-term safety data for the next-generation SirPlux Duo drug-coated balloon (DCB), as well as its performance in de novo coronary artery disease (CAD).
The SirPlux Duo DCB delivers low-dose, long-term release of both sirolimus and paclitaxel to inhibit cell growth. The ANT nanoparticle drug-encapsulation and delivery platform is designed to provide safe, reliable, and sustained bioavailability of the two synergistic drugs in tissue, the company said in a press release.
“Today, we celebrate two remarkable accomplishments for ANT and SirPlux Duo DCB,” said Marwan Berrada, co-founder and CEO of ANT. “I welcome the participation of a new strategic partner as this additional investment will bolster ANT’s clinical programmes and accelerate the path toward US IDE [investigational device exemption] approval for the SirPlux Duo DCB. I also thank the entire clinical team and ANT’s scientific advisory board for their efforts and expertise to reach these important milestones for the company.”
“I am pleased to be part of the initial cases of ANT’s novel technology,” says investigator Rishi Puri (Cleveland Clinic, Cleveland, USA). “This technology will allow me to offer a safe and prolonged therapy for preventing coronary restenosis without leaving a permanent implant behind.”
“The SirPlux Duo DCB could have an immense impact on how we approach coronary interventions,” commented Investigator Jith Somaratne (Auckland City Hospital and The Heart Group, Auckland, New Zealand). “Combining two potent antiproliferative drugs in a reliable nanoparticle platform may be the key to simultaneously reducing adverse events and maintaining patency. This study provides a critical step in proving the safety and clinical performance of next-generation DCBs.”
The company plans to share angiographic data from its ADVANCE-DCB FIH trial in early 2024.