ALM-488 is a peptide-dye conjugate designed to fluorescently highlight nerves in real time during surgery
LA JOLLA, Calif. , Aug. 23, 2022 /PRNewswire/ -- Alume Biosciences, Inc, a leader in the field of nerve-targeted diagnostics and therapeutics, today announced that the first patient has been dosed in a Phase 3 pivotal study of ALM-488 (NCT05377554). ALM-488 is a peptide-dye conjugate designed to highlight nerves with fluorescence in real time during surgery.
Alume Announces First Patient Dosed in Phase 3 Pivotal Study for Intraoperative Nerve Fluorescence.
"The successful initiation of this Phase 3 pivotal study is another major milestone for Alume. It marks the final phase of clinical trial testing for ALM-488 for patients undergoing Head and Neck Surgery" said Brett Berman , MD, chief medical officer at Alume Biosciences. "This study underscores our commitment to improve intraoperative visualization of nerves, enabling Precision Surgery™".
Alume successfully completed Phase 1/2 studies of ALM-488 in patients undergoing Head and Neck Surgery in 2021. The Phase 3 studies are being conducted at multiple academic medical centers throughout the US, and they are projected to be completed in 2023. "We look forward to exploring the power of ALM-488 as an intraoperative tool to identify nerves and potentially improve outcomes for our patients," said Karthik Rajasekaran MD, principal investigator at University of Pennsylvania.
About ALM-488 ALM-488 is a proprietary fluorescent peptide-dye conjugate in the visible spectrum and can be visualized with fluorescently enabled instrumentation including filter modified loupe systems, portable handheld systems, microscopes and laparoscopes. ALM-488 binds to the extracellular matrix of nerves, allowing real-time nerve illumination during surgery. ALM-488 is expected to have broad surgical application due to unique characteristics of binding that are independent of myelin. This allows ALM-488 to highlight multiple types of nerves including motor, sensory, and autonomic. Degenerated nerves, critically important during reconstructive procedures, are also highlighted with ALM-488. Surgeries where nerves are potentially at risk include procedures in the skull base, head and neck, spine, and nerve sparing prostatectomy. In vivo studies also indicate that ALM-488 has adequate pharmacokinetic characteristics to support clinical utility for the labelling of ureters in urology, gynecology and lower abdominal surgical indications.
About Alume Biosciences Alume Biosciences is a late-stage clinical biotechnology company developing nerve specific targeting molecules. In addition to ALM-488, Alume is developing other nerve specific agents for diagnostic and therapeutic indications. The company was founded in 2017 and is headquartered in the Johnson & Johnson Innovation incubator JLABS @ San Diego. Learn more about Alume Biosciences at https://alumebiosciences.com
Media contact: Yana.Campen@alumebiosciences.com
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