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Siemens Healthineers, Imagion to move forward on Phase 2 study of molecular MR imaging agent

by John R. Fischer, Senior Reporter | July 05, 2023
Molecular Imaging MRI
MagSense nanoparticle
Siemens Healthineers will help Imagion Biosystems Limited, an Australian manufacturer of nonradioactive and precision diagnostic molecular imaging technology, launch and conduct a new multisite Phase 2 study in Australia and the U.S. for its MagSense HER2 imaging agent.

MagSense technology is made up of magnetic nanoparticles that bind to tumors in patients with HER2-positive breast cancer to make MR scanners more sensitive and selective in pinpointing these maglignancies. According to the company, the agent will enable functional imaging, and reduce reliance on CT, X-rays, and other radiation-based imaging modalities.

Already working with the company on its MagSense Phase 1 study in Australia, Siemens Healthineers has extended this agreement for the next two years, and will provide it with clinical expertise from its American subsidiary, Siemens Medical Solutions USA, to optimize MR protocols and facilitate limited technical support at clinical sites.
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“This collaboration creates a win-win situation in which Imagion benefits from having access to the Siemens Healthineers MR research team’s knowledge and expertise, while providing Siemens Healthineers direct visibility to our work to make molecular MR a reality,” said Bob Proulx, executive chairman of Imagion Biosystems, in a statement.

Imagion presented its first clinical data in December 2022 at the San Antonio Breast Cancer Symposium, and has since released an independent review.

Earlier this year, the company announced that it would be filing an investigational new drug application with the FDA in Q4 2023 or Q1 2024.

It will collect nonclinical and clinical data supporting a phase 2 study in the U.S., and design additional MagSense HER2 imaging agent material to support the study. It will also choose clinical investigators and sites where the study will take place.

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