Alcami Supports Phase II/III Trial Supply of the Nectero EAST® System
2023-10-17
临床1期临床申请
WILMINGTON, N.C., Oct. 17, 2023 /PRNewswire/ -- Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today welcomed the recent announcement by Nectero Medical that they have received clearance from the U.S. Food and Drug Administration of their IND application to initiate Phase II/III trial of the Nectero Endovascular Aneurysm Stabilization Treatment (EAST®) System for the treatment of small- to-mid-sized abdominal aortic aneurysms (AAA).
Nectero Medical is developing a novel treatment to stabilize growth and potentially prevent rupture of smaller AAA. The Nectero EAST System is comprised of a dual-balloon delivery catheter and stabilizer 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 U.S. were recently published in the Journal of Vascular Surgery and showed that a single, localized 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 cGMP 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 Mr. 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 US 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."
Established over 40 years ago, Alcami has evolved into one of the industry's premier drug product development and manufacturing partners. Alcami offers six sterile filling suites for injectables. With co-located early development, pre-formulation capabilities, and redundant laboratory and manufacturing network, Alcami is well positioned to support oral solids and sterile drug product programs from clinical scale to commercial supply.
Nectero EAST® is a registered trademark of Nectero Medical.
About Alcami Corporation
Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Alcami serves pharmaceutical and biotech companies of all sizes for small molecules and biologics, providing customizable and innovative solutions for analytical development, clinical to commercial sterile and oral solid dose drug product manufacturing, packaging, microbiology, cGMP biostorage, environmental monitoring, and pharmaceutical support services. Alcami's private equity ownership includes GHO Capital, The Vistria Group, and Ampersand Capital Partners. For more information, please visit alcaminow.com.
SOURCE Alcami Corporation
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