Multicenter Open-Label Feasibility Study of Intraoperative Nerve and Ureter Visualization With Bevonescein in Patients Undergoing Minimally Invasive Abdominopelvic Surgery

Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery

Start Date16 Oct 2024

Sponsor / Collaborator

Alume Biosciences, Inc.Startup

NCT06227585 / RecruitingPhase 2

Feasibility Study- REVEAL 475 System for Bevonescein-Assisted Intra-Operative Visualization of Nerves in Head and Neck Surgery

A feasibility study to evaluate the usability of the REVEAL 475 system in patients treated with bevonescein for nerve visualization during surgery.

Start Date29 Nov 2023

Sponsor / Collaborator

Alume Biosciences, Inc.Startup

[+1]

NCT05377554 / RecruitingPhase 3

ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate ALM-488.

Start Date29 Apr 2022

Sponsor / Collaborator

Alume Biosciences, Inc.Startup

[+1]

100 Clinical Results associated with Bevonescein

100 Translational Medicine associated with Bevonescein

100 Patents (Medical) associated with Bevonescein

Literatures (Medical) associated with Bevonescein

01 Aug 2023·Otolaryngology–Head and Neck Surgery

Identification of Degenerated Murine Facial Nerves With Fluorescence Labeling After Transection Injury

Article

Author: Hom, Marisa ; Crawford, Kayva L. ; Nguyen, Quyen T. ; Rosenthal, Eben L. ; Orosco, Ryan K. ; Lee, Yu‐Jin

AbstractObjectiveDelayed peripheral nerve repair is complicated by nerve degeneration and atrophy that can prevent identification. We use a murine facial nerve transection model to demonstrate the efficacy of ALM‐488 (bevonescein) in labeling degenerated facial nerves with quantitative image analysis and qualitative survey data.Study DesignProspective cohort study.SettingLaboratory.MethodsTen wild‐type mice underwent transection of the lower facial nerve division with subsequent degeneration. Either 9 (n = 5 mice) or 12 (n = 5 mice) weeks later, mice underwent intravenous infusion of ALM‐488 with in vivo real‐time fluorescence imaging (FL) of the facial nerve. Using ImageJ, the mean gray value of each nerve segment under white light reflectance (WLR) and FL was compared to that of adjacent soft tissue to calculate the signal‐to‐background ratio (SBR). A survey was distributed to evaluate the perceived utility of ALM‐488 in surgeon identification of degenerated nerves.ResultsThe mean SBR of degenerated nerves was 1.08 (standard deviation [SD]: 0.07) under WLR and 2.11 (SD: 0.31) under FL (p < 0.001). In mice with degenerated nerves, survey participants identified on average 3.01 (SD: 1.84) nerve branches under WLR and 5.73 (SD: 1.88) under FL (p < 0.0001). Under FL, 47 of 48 survey responses correctly identified isolated, degenerated nerves; in contrast, only 12 responses identified degenerated nerves under WLR (p < 0.0001).ConclusionPreoperative intravenous infusion of ALM‐488 with FL improves the identification of degenerated facial nerves. ALM‐488 also improves surgeon confidence in nerve identification, particularly in degenerated nerve branches that are not visible with WLR.

13 Jun 2013·The Journal of Physical Chemistry BQ3 · CHEMISTRY

Interaction of Phospholipid Langmuir Monolayers with an Antibiotic Peptide Conjugate

Q3 · CHEMISTRY

Article

Author: Kiss, Éva ; Keszthelyi, Tamás ; Hill, Katalin

The interactions between phospholipid monolayers and a peptide conjugate of the antituberculotic agent isoniazide (INH) were investigated by sum-frequency vibrational spectroscopy. The primary objective of the present work was to provide a detailed picture of the molecular interactions of the INH-peptide conjugate with phospholipid monolayers by detecting the changes in the monolayer structure resulting from these interactions. In order to gain a thorough understanding, three types of experiment were performed: (i) changes induced in the structure of the precompressed phospholipid monolayer upon injection of the INH-peptide conjugate were followed; (ii) the structures of the phospholipid monolayers spread onto the solution of the INH-peptide conjugate were characterized; (iii) the structures of mixed monolayers of phospholipid and the INH-peptide conjugate were studied. Using a chain perdeuterated phospholipid, it was possible to examine the changes in alkyl chain ordering without interference from INH-peptide conjugate vibrations and investigate the effect of the INH-peptide conjugate on the ordering of the phosphocholine headgroups. We confirmed that peptide conjugation strongly influences the interactions of INH with the lipid monolayer, resulting in enhanced cell penetration ability. The interactions formed between the INH-peptide conjugate in its ordered adsorption layer and the phospholipid molecules deposited onto this solution were found to be significantly stronger than those formed by the INH-peptide conjugate with a compressed lipid monolayer. Nonetheless, both types of interaction contribute with a condensing effect to an increased ordering of the phospholipid alkyl chains in the monolayer.

News (Medical) associated with Bevonescein

11 Jan 2023

·www.prnewswire.com

ALUME BIOSCIENCES SECURES $13 M IN SERIES B FINANCING

LA JOLLA, Calif., Jan. 10, 2023 /PRNewswire/ -- Alume Biosciences, Inc. has secured $13 million in Series B financing to advance its lead candidate, Bevonescein (ALM-488), in Phase 3 clinical trials. Alume, a leader in the field of nerve-targeted diagnostics and therapeutics, announced in August, 2022 that the first patient had been dosed in a Phase 3 pivotal study of ALM-488 for intra-operative visualization of nerves in head and neck surgery (NCT05377554). ALM-488 is a peptide-dye conjugate designed to highlight nerves with fluorescence in real-time during surgery. The Phase 3 pivotal studies are underway at major academic hospitals across the U.S. With the $13 million raised in the Series B fundraising, together with funds raised in an earlier Series A financing and additional non-dilutive funding received through grants, the Company has raised over $30 million to fund the clinical development program for its lead candidate, advance its development portfolio and support potential regulatory filings. ALUME BIOSCIENCES SECURES $13 M IN SERIES B FINANCING "This is an important milestone for Alume. This funding brings us one step closer to improving intraoperative visualization of nerves for patients undergoing surgery, enabling Precision Surgery™" said Magda Marquet, a member of Alume's Board of Directors. 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, which is an insulating layer around nerves. 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, and 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

Phase 3Financing

23 Aug 2022

·www.prnewswire.com

Alume Biosciences Announces First Patient Dosed with ALM-488 in Phase 3 Pivotal Study in Patients Undergoing Head and Neck Surgery

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. Continue Reading Alume Announces First Patient Dosed in Phase 3 Pivotal Study for Intraoperative Nerve Fluorescence. Tweet this Alume Biosciences Announces First Patient Dosed with ALM-488 in Phase 3 Pivotal Study in Patients Undergoing Head and Neck Surgery. "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 Media contact: [email protected] SOURCE Alume Biosciences

100 Deals associated with Bevonescein

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Contrast agents	Phase 3	US	Alume Biosciences, Inc.Startup	23 Aug 2022
Nerve injury	Phase 2	US	Alume Biosciences, Inc.Startup	16 Oct 2024

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