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.
Medical-imaging company Imagion Biosystems Lodges IND with FDA for Phase 2 Trial of MagSense® HER2 targeted imaging agent
Imagion Biosystems, Ltd. (ASX: IBX) announced that the company has lodged an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its MagSense® targeted imaging agent. Following FDA approval, the company expects to start a Phase 2 clinical trial with the imaging agent for the detection of nodal metastases in HER2+ breast cancer patients.
