Imagion Biosystems is pleased to report that it has received approval from the Human Research Ethics Committee (HREC) for the MagSense® HER2 Phase I study for metastatic breast cancer. With the study now approved the Company can proceed with finalising contracts with individual study sites.
Additionally, the Company reports that manufacturing of the MagSense® HER2 nanoparticle formulation for the study remains on track, having successfully completed bulk batch production. The company expects to complete the final step of Good Manufacturing Practice (GMP) compliant packaging of the material on time to support the start of the study.
Imagion Biosystems Executive Chairman Bob Proulx said, “We are very pleased with our progress and will now be working diligently with our planned study sites to commence the study this calendar quarter as we have previously advised.”