Imagion Biosystems Limited (ASX: IBX), a clinical-stage medical imaging company dedicated to transforming how cancer is diagnosed and treated by developing MagSense®, a first-of-its-class MRI imaging agent, has announced it has secured central Institutional Review Board (IRB) ethics approval for its Phase 2 MagSense® trial. This crucial milestone clears a key ethics and regulatory hurdle for the company’s HER2-positive breast cancer study, enabling the advancement to active site initiation and patient recruitment.
Advarra, Inc. granted the central IRB approval, confirming that the study protocol, informed consent process, and participant safeguards align with U.S. ethical and regulatory standards for clinical research involving human participants. This approval, combined with the previously announced United States Food and Drug Administration (FDA) Investigational New Drug (IND) clearance, solidifies the necessary approvals to commence the trial in the United States. The strategic use of a single central IRB process is designed to streamline activation across multiple participating clinical sites, supporting more efficient site activation and patient enrolment by reducing duplicative reviews.
With these approvals in place, site activation activities are now well underway, including finalising site contract execution, investigator training, and patient recruitment planning. Patient enrolment is set to commence following the first site activation. Ward Detwiler, President of Imagion’s U.S. operations, stated, “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.” He added that with both regulatory and ethics approvals secured, the focus remains on completing site activation and advancing towards opening the study for patient enrolment to generate Phase 2 efficacy and safety data.
