Imagion Biosystems Ltd (IBXXF)

[Hncher]

Finally, a positive step forward..

Imagion Biosystems Successfully Completes Toxicology Study

Imagion Biosystems has achieved a key milestone in its progress to first-in-human testing with the successful completion of a toxicology safety study of its lead MagSense™ nanoparticle formulation for the detection of HER2 metastatic breast cancer.

MELBOURNE — Imagion Biosystems Limited (ASX: IBX), a company dedicated to improving healthcare through the early detection of cancer, has achieved a key milestone in its progress to first-in-human testing with the successful completion of a toxicology safety study of its lead MagSenseTM nanoparticle formulation for the detection of HER2 metastatic breast cancer. The study was completed on time and no observable adverse effects were reported.

Based on recommendations from the U.S. Food and Drug Administration (FDA) the Company had engaged a contract research organization to undertake the toxicology study following Good Laboratory Practices (GLP). The safety demonstrated in the toxicology study report will be used to support filings with regulatory and clinical authorities to proceed to first-in-human testing.

“While we fully expected this outcome, it is good to have this hard evidence in hand,” said Bob Proulx, Executive Chairman. “The assessment of toxicological safety of our nanoparticle formulation is a big de-risking step. We will be breaking new ground in medical imaging bringing a targeted bio-safe iron-oxide nanoparticle to first-in-human studies.”