MagniXene™ imaging agent

MagniXene™ is Xemed’s trade name for its hyperpolarized Xenon-129 product. On previous pages we discussed our technology for its production, and its diverse applications. Here we discuss its evolution to becoming a commercial product.

In February of 2004 the US FDA accepted Prof. Hersman’s sponsorship of hyperpolarized Xenon-129 as an Investigational New Drug. During the months and years that followed, Prof Hersman worked with scientific and medical collaborators to assemble infrastructure and begin clinical trials. The group of Dr. Sam Patz at the Brigham and Women’s Hospital and Harvard Medical School has been central to this effort. This collaborative effort was funded as a Bioengineering Research Partnership by the National Heart, Lung and Blood Institute, a division of the National Institutes of Health.

The hospital devoted a 0.2T GE Profile IV for the sole use of hyperpolarized imaging development, which was augmented to send and receive signals for xenon. Recruitment of healthy human subject volunteers for exploratory imaging sessions commenced in May 2005. Over a period of 18 months we tested inhalation sequences and imaging protocols for a wide range of potential applications. Over 250 measurements were conducted on 24 different volunteers with no adverse events. In January of 2007, the FDA accepted our request to proceed to Phase II, allowing recruitment of subjects with mild to moderate lung disease for our trials.

A number of elements must be specified, validated, and/or refined during an FDA Phase II trial to demonstrate efficacy of a diagnostic agent. Many of these elements are being pursued within the existing Boston-based collaboration. Xemed is encouraging participation in this Phase II demonstration from other groups with imaging expertise. Many have already expressed interest.

Xemed will coordinate the Phase II process to demonstrate the efficacy of MagniXene™ through partnerships within its MagniXene™ Imaging Network. Xemed anticipates that Phase II could require three to four years. Over that time we hope to have grown our Network to include a dozen research centers, each addressing scientific and clinical questions important to validating MagniXene™. Subsequently we will lead a Phase III clinical trial to demonstrate improved outcomes in patients with lung disease whose disease is managed with MagniXene™. Phase III would require a similar period, three to four years. After six to eight years of research and development, Xemed intends to apply to the US FDA for a New Drug Application for MagniXene™.