Imagion Biosystems secures ethics approval for trial
- Imagion Biosystems obtained central IRB ethics approval from Advarra for its Phase 1b/2 clinical trial.
- The company's share price remained unchanged at $0.007 following the announcement.
- Ethics clearance allows active site initiation and patient recruitment for the HER2-positive breast cancer study.
Imagion Biosystems (ASX:IBX) has secured central Institutional Review Board ethics approval from Advarra for its Phase 1b/2 clinical trial of the MagSense HER2 imaging agent.
The central ethics clearance follows the previously received Food and Drug Administration Investigational New Drug approval, completing key regulatory requirements needed to start the trial in the United States.
“Central IRB approval is an important milestone as we progress towards study activation, and it reflects the disciplined work of our team in designing and preparing for this clinical trial,” said Imagion Biosystems President of U.S. Operations Ward Detwiler.
Using a single central review process is designed to streamline trial start-up and reduce administrative delays across participating clinical sites.
Following the announcement, the Imagion Biosystems share price was unchanged at $0.007.
The medical imaging company focuses on improving healthcare outcomes through early and accurate cancer detection.
Prior to this development, the business raised $3.8 million in firm commitments to support its clinical study progress.
