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- Imagion Biosystems (IBX) receives positive results from its first-in-human study for the MagSense HER2 breast cancer imaging agent (MagSense), designed to detect cancer in its early stages
- The study shows no safety issues relating to the MagSense and all patients have tolerated the administration and dosage of the interjectable, and is capable of reaching the lymph nodes
- Based on the observations, Imagion plans to move forward with scale-up activities to support further development and clinical studies that would support regulatory submissions and if effective, move to the commercialisation stage
- IBX shares are up 41.9 per cent, trading at 6.1 cents per share
Imagion Biosystems (IBX) received positive results from its first-in-human study for the MagSense HER2 breast cancer imaging agent (MagSense), designed to detect cancer in its early stages.
The study is intended to investigate the potential for MagSense to be used for nodal staging of HER2 positive breast cancer by detecting if tumour cells have metastasised to the lymph nodes.
The first clinical investigation was to initially deduce if the MagSense is safe and tolerable to the patient, with each patient receiving an injection of the MagSense HER2 targeted imaging agent and evaluation by two imaging modalities: magnetic resonance imaging (MRI) and Imagion’s proprietary magnetic relaxometry (MRX) technology.
“We can say that there have been no safety issues reported related to the MagSense HER2 imaging agent and that all patients have tolerated the administration and dosage of the injectable,” Dr Jane Fox, the study Principal Investigator from Monash Health stated.
“We have observed that the imaging agent, as administered, is capable of reaching the lymph nodes.”
Bob Proulx, Executive Chairman of Imagion Biosystems says that the initial results “provide sufficient justification for [Imagion] to continue the study”.
Based on the observations, Imagion plans to move forward with scale-up activities to support further development and clinical studies that would support regulatory submissions.
If one of the imaging methods is shown to be effective in pivotal studies, the MagSense HER2 test would be commercialised as a non-invasive alternative reducing the need for biopsies for nodal staging.
IBX shares are up 41.9 per cent, trading at 6.1 cents at 11:30 am AEDT.
