Imagion Biosystems (ASX:IBX) says it has achieved a key milestone in the development of it first-in-human testing.
The company announced has successfully optimised the nanoparticle formulation for its first intended clinical product, a test for the detection of HER2 breast cancer cells in the lymph nodes, and will now move the product forward into clinical development.
The company also said its partner will proceed with manufacturing of the first batch of the HER2 nanoparticle test reagent which will be used in a toxicology study, a prerequisite to the its planned first-in-human study expected to be undertaken in early 2019.
“This milestone is a pivotal achievement and represents a significant technical advance in our development plan,” said Bob Proulx, executive chairman of Imagion Biosystems.
“As we have previously communicated, optimizing our nanoparticle formulation is a key step in moving us closer to a first-in-human clinical study. The manufacturing of this initial batch of the formulation allows us to conduct our toxicology study and keeps us on track to commence the first-inhuman study early next year.”
The company added that, during the remainder of 2018 and prior to initiation of the first-in-human study, it expects to have the nanoparticles tested for safety and toxicity, initiate production of the second batch of material for the initial human research study, and seek regulatory and institutional approval for the human research study.