- Imagion Biosystems (IBX) is gearing up for the first-ever clinical-stage trial of its MagSense diagnostic imaging technology
- The FDA-designated ‘Breakthrough Device’ is being developed with the aim of improving early-stage cancer detection
- It works by using nanoparticles coated with tumour targeting antibodies which attach to the cancer cells, enabling them to be identified by sensors
- The phase one trial will assess the safety and efficacy of the MagSense nanoparticles in 15 to 20 HER2 breast cancer patients
- If human ethics approval and site contracts are secured on time, the company is expecting to begin the trial before the end of the year
- Company shares are trading 10 per cent higher for 3.3 cents each
Imagion Biosystems (IBX) is gearing up for the first-ever clinical-stage trial of its MagSense diagnostic imaging technology.
The phase one study will enrol 15 to 20 HER2 breast cancer patients and, if Human Research Ethics Committee approval is granted and study sites are contracted on time, the study will begin in the final quarter of 2020.
The Australian Food and Drug Administration-designated ‘Breakthrough Device’ is being developed with the aim of improving the early-stage detection of cancer.
It works by using nanoparticles coated with tumour targeting antibodies, which attach to the cancer cells, enabling them to be identified by MagSense sensors in a method known as super magnetic relaxometry.
Executive Chairman and CEO Bob Proulx said Australia was chosen for the first-in-human trial for several reasons, including its favourable regulatory and clinical testing environment.
“For Imagion, there are a number of advantages to conducting the study in Australia, including a lower overall cost and the ability to expand the study to include MRI and still execute within our desired timeframes, thanks to the recently announced collaboration with Siemens Healthineers.”
In May this year, Imagion secured the collaboration with Siemens to develop the use of the MagSence nanoparticles as MRI contrast agents, a product used to improve the image quality and resolution.
“While the primary objective of the study is to demonstrate that our nanoparticles are safe, it will also generate valuable data to show the effectiveness of our targeted nanoparticles in detecting the presence and spread of HER2 breast cancer using two different imaging modes. These study data will help us assess the best commercial pathway for improving nodal staging of HER2 breast cancer,” explained Mr Proulx.
“We have worked hard to hold to our goal of entering the clinic this year. As previously reported, the first phase of manufacturing has been completed on time and the second phase continues on schedule, with no impact from the global pandemic so far. We are now focused on securing the clinical sites and obtaining the necessary clearances to commence the study,” he added.
Company shares are trading 10 per cent higher for 3.3 cents each at 12:35 pm AEST.