Imagion Biosystems (ASX:IBX) says it has achieved a key milestone in its progress to first-in-human testing with the commencement of a toxicology safety study of its lead nanoparticle formulation for the detection of HER2 metastatic breast cancer.
Imagion Biosystems is developing the new non-radioactive diagnostic imaging technology. The company said its MagSense technology would be a first in molecular imaging employing targeted bio-safe iron oxide nanoparticles.
The company said it engaged a contract research organisation to undertake the toxicology study based on recommendations from the US FDA. It said the study is expected to be completed in early May 2019.
The study will assess the safety profile of the company’s lead diagnostic nanoparticle formulation. It described it as "an important part of the regulatory and clinical applications" needed for first-in-human testing.
“This is a significant milestone in the development of our MagSense diagnostic imaging technology,” said executive chairman Bob Proulx. “Assessment of toxicological safety of our tumor targeting nanoparticle formulation is a big de-risking step and will be a key factor allowing us to move forward to first-in-human studies.”