Imagion Biosystems Limited (ASX:IBX), a company dedicated to improving healthcare through the earlier detection of cancer, is pleased to announce it has achieved a key milestone in its drive to first-in-human testing. The Company has successfully optimized 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’s manufacturing 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 Company’s 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-in-human study early next year.”
During the remainder of 2018 and prior to initiation of the first-in-human study, the Company expects to:
• Have the nanoparticles tested for safety and toxicity
• Initiate production of a second batch of material for the initial human research study
• Seek regulatory and institutional approval for the human research study
About Imagion Biosystems
Imagion Biosystems is at the crossroads of biotechnology and nanotechnology. Its novel bioimaging and nanomagnetic detection systems have been developed specifically to detect cancer and other diseases earlier and with higher specificity than is currently possible. With MagSenseTM technology, the company has the potential to optimize patient care and reduce mortality rates across various cancer indications. Imagion Biosystems listed on the Australian Securities Exchange (ASX) in June 2017.
Australian Media & Investor Relations:
Matt Wright, NWR Communications
U.S. Media Contact: