Some interesting stuff here with the SPIONs. My background is not in imaging, so I'm not even going to pretend that I understand the underlying mechanisms here. But I will say this- if the SPIONs are very similar/basically the same as a iron infusion injection, then my takeaway is that they are very safe in humans. Make of that what you will.
Essentially, severe cases of anaemia are sometimes treated with intravenous iron infusions. Many different forms of infusions exist, including things like Ferrinject etc. I'm not familiar with Ferraheme, but it has been many years since I worked in clinical medicine! In any case, reactions to iron infusions are pretty rare. Some people do have severe allergic reactions (but that's already an issue with CT and MRI contrast anyway) and if the iron extravasates from the cannula site, it can lead to skin pigmentation.
But iron infusions have demonstrated safety in humans meaning that the SPIONs would most likely be entirely safe and non-toxic as well. People have been posting about this for a while now- but the implications here are pretty huge. MRI contrast by itself is a huge field, let alone MRX. I think IBX is really sitting at the cusp of two major paths of commercialisation.
My personal feeling is that we will have no problems demonstrating safety in the upcoming trials and will be pushing on to more comprehensive trials demonstrating efficacy soon afterwards. Let's hope that before too long we have a PS announcement saying that HREC approval has been granted.
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