MagniLium™ imaging agent

MagniLium™ is Xemed’s trade name for its hyperpolarized Helium-3 product. On previous pages we discussed our technology for its production, and its applications in the gas space of lungs. Here we discuss its evolution to becoming a commercial product.

During early 1990s researchers at Princeton and Stony Brook collaborated in the first demonstrations of hyperpolarized gas MRI. The Princeton group formed a spinoff company, Magnetic Imaging Techologies, Inc. (MITI), to commercialize the technology. That company developed a commercial polarizer, capable of producing roughly a liter of either Helium-3 (with polarization ~35%) or Xenon-129 (with polarization ~7%). Several patents were awarded and licensed to MITI. During the years that followed, the company was sold to Nycomed-Amersham which later became Amersham Health, which itself was later sold to GE Healthcare. During those years, this technology group produced a dozen polarizers of Helium-3, placed them at a dozen clinical sites, and began FDA trials. In May 2007 GE Healthcare announced that they were no longer pursuing hyperpolarized Helium-3 as a commercial product.

In Europe a parallel effort was underway under a different model. Researchers at the University of Mainz had undertaken a decade-long effort to scale up a physics process for producing hyperpolarized Helium-3 called Metastability Exchange Optical Pumping (MEOP). The original goal of that effort was to perform a specialized nuclear physics measurement at a high energy electron accelerator. Nevertheless, the result of that effort was the Mark III polarizer, a machine capable of producing as high as 80 bar-liters per day of hyperpolarized Helium-3 with over 60% polarization.

A consortium of clinics across Europe joined in an independent project called Polarized Helium in Lungs (PHIL), funded by the EC between 2000 and 2004. This project utilized a central production model: Gas was hyperpolarized in Mainz, transferred into high-purity glass containers, placed into magnetic boxes, and shipped to remote locations. Because the lifetime of the polarization could be as high as one hundred hours or more, the imaging agent suffered only a modest decrease in strength in transit. In 2007 this network was reconstituted as PHeLINet, now with seventeen institutions, to continue development and dissemination of hyperpolarized Helium-3 imaging.

Xemed’s hyperpolarized Helium-3 imaging agent, MagniLium™, offers researchers already conducting hyperpolarized Helium-3 research an attractive alternative. In the US, researchers using the existing GE polarizers could upgrade to a Xemed polarizer. These researchers would enjoy an increase in the productive output of their polarizer by a factor exceeding one hundred and their research would contribute to validating a drug which would one day become commercially available to patients in need. In Europe, researchers receiving periodic deliveries of hyperpolarized Helium-3 could upgrade to a Xemed polarizer. They could conduct several scans on each patient and perform several patients per day. They would also be liberated from delivery schedules and other potential uncertainties.