Alcami has welcomed the recent announcement by Nectero Medical that it has received clearance from the US Food and Drug Administration (FDA) of their investigational new drug (IND) application to initiate a Phase II/III trial of the Nectero Endovascular Aneurysm Stabilisation Treatment (EAST) system for the treatment of small- to-mid-sized abdominal aortic aneurysms (AAA).
Nectero Medical is developing a novel treatment to stabilise growth and potentially prevent rupture of smaller AAA, an Alcami press release details. The Nectero EAST system is comprised of a dual-balloon delivery catheter and stabiliser mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and to potentially reduce the risk of further degradation. Early Phase I clinical results on the initial 20 patients treated outside of the USA were recently published in the Journal of Vascular Surgery and showed that a single, localised PGG administration to patients with small- to mid-sized infrarenal AAAs was safe and demonstrated the potential to slow the growth of AAAs.
“We congratulate Nectero Medical on their recent IND clearance and proudly support the work they are doing to address a significant unmet clinical need and improve outcomes in AAA patients,” commented Jamie Iudica, chief manufacturing officer of Alcami. Alcami’s support of Nectero Medical’s drug/device combination product has consisted of accelerated analytical method and process development activities and sterile drug product [Current Good Manufacturing Practice] manufacturing in support of clinical studies.” The integrated service we have provided is a testament to our technical depth, modern capabilities, and relentless focus on the success of our customers,” added Iudica.
“We thank the Alcami team for their continued support of the important work we are doing,” commented Jack Springer, president and chief executive officer of Nectero Medical. “Nectero Medical is addressing the over 1,000,000 patients in the USA with an AAA and currently no method of treatment. Alcami was able to move quickly and provide high-quality deliverables in support of our past and ongoing projects.”