Vergent Bioscience has completed subject enrolment for its VISUALIZE trial, which is designed to assess the efficacy and safety of abenacianine for injection (VGT-309) in lung cancer patients.
Previous clinical studies have indicated that abenacianine for injection offers surgeons a ‘molecular sight’, allowing them to visualise tumour tissue more effectively during minimally invasive surgeries (MIS), along with the robotic-assisted methods.
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The Phase II multi-centre, open-label trial involved 89 patients across six sites in the US and Australia, each receiving a 0.32mg/kg dose of the agent 12 to 36 hours before their surgery.
During the trial, each patient was administered the injection as a short infusion before surgery. Surgeons then attempted to identify tumours using standard techniques, followed by the use of a near-infrared (NIR) endoscope to confirm the presence of tumour tissue, with pathology providing further confirmation.
The trial’s primary efficacy endpoints included intraoperative visualisation of tumours, surgical margin assessment, and the identification of additional cancers/positive lymph nodes that might not have been detected preoperatively.
Vergent Bioscience CEO and president John Santini said: “The VISUALIZE trial will provide additional, valuable insights illuminating the potential of our novel imaging agent to address existing deficits in tumour visualisation during lung surgery.
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By GlobalData“Completing enrolment in the trial is an exciting milestone that reflects our team’s dedication, as well as the commitment of the VISUALIZE clinical investigators and study participants. We look forward to sharing the results of this study.”
Subsequent to the analysis of the trial data, Vergent plans to progress abenacianine for injection into a Phase III study.
Assuming positive outcomes from this phase, the company anticipates filing a new drug application for lung cancer surgery.
Abenacianine for injection, a tumour-targeted fluorescent imaging agent binds covalently to cathepsins, proteases that are overexpressed in various solid tumours.
