Imagion Biosystems Secures Central Ethics Approval
Key points
- Central IRB ethics approval received for Phase 2 trial in HER2-positive breast cancer
- Advarra IRB approved protocol, informed consent, and study materials
- Streamlined site activation and patient recruitment underway
Full summary
Imagion Biosystems Ltd, an ASX-listed medical imaging company, has received central Institutional Review Board (IRB) ethics approval for its Phase 2 clinical trial of MagSense® HER2 Imaging Agent. This milestone clears a key regulatory hurdle and paves the way for patient enrolment in the United States. The trial aims to improve cancer detection using non-radioactive, bio-safe magnetic nanoparticles. With IRB approval and FDA Investigational New Drug (IND) clearance secured, the company is now finalizing site activation activities, including contract execution and investigator training, with patient enrolment expected to commence shortly.
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