Imagion Biosystems 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.
Based on recommendations from the U.S. Food and Drug Administration (FDA) the Company has engaged
a contract research organization to undertake the toxicology study following Good Laboratory Practices (GLP). The study is expected to be completed in early May 2019. The report from the study will outline the safety profile of the Company’s lead diagnostic nanoparticle formulation and will be 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 Bob Proulx, Executive Chairman. “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.”
Imagion is working to break new ground in medical imaging with the MagSense technology. Current medical imaging technologies identify regions of interest but don’t specifically identify diseased tissues. PET tracers aim to provide improved specificity but expose patients to radioactivity. Untargeted iron oxide nanoparticles have been shown to be bio-safe and are used off-label as an MRI contrast agent, but their lack of specificity has limited their diagnostic utility. Following positive results from first-in-human studies, Imagion Biosystems’
MagSense technology would be a first in molecular imaging employing targeted bio-safe iron oxide
This announcement has been lodged with the Australian Securities Exchange. View the announcement, Imagion Biosystems Initiates Toxicology Study.