Imagion Biosystems’ IND Application for MagSense® Phase 2 Clinical Trial Clears FDA Review
Imagion Biosystems, Ltd. (ASX: IBX) has announced that the US Food and Drug Administration (FDA) completed its review of the company’s investigational new drug (IND) application, issuing a “Study May Proceed” letter for Phase 1b/2 clinical trials of the MagSense® Imaging Agent in HER2+ breast cancer.
MagSense® is a first-of-its-class molecular MRI (mMRI) imaging agent that uses non-radioactive, bio-safe nanoparticles to help clinicians detect cancer earlier and with greater precision. Phase 1b/2 will be a combined trial designed to confirm the safety profile (Phase 1b) and evaluate efficacy in detecting nodal metastases (Phase 2) in patients with HER2+ breast cancer.
“This is a major win for our team and partners and an important milestone for the company. Molecular MRI could be a true breakthrough in medical imaging,” said Imagion Biosystems President Ward Detwiler. “We are one step closer to helping the many patients battling HER2+ breast cancer.”
Dr. Mohammad Eghtedari, section chief of Women's Imaging at City of Hope Cancer Center in Los Angeles, will serve as the trial’s principal investigator (PI). A recognized expert in diagnostic radiology, Eghtedari previously participated as an independent reviewer of MagSense® in the company’s Phase I trial.
