Xemed announced today receipt of a “Notice of Award” for its Competitive Continuation SBIR Phase 2 proposal entitled “Regulatory Advancement of HXe as a Diagnostic MRI Contrast Agent” from the National Heart Lung and Blood Institute. Principal Investigator Iulian C. Ruset, Xemed’s Director of Imaging Applications, will lead the collaboration, which includes teams from Xemed, from the University of Virginia’s Center for In-vivo Hyperpolarized Gas MR Imaging, and from the Washington University of St Louis Mallinckrodt Institute of Radiology. Our goals for this $3M three year project are to collect safety endpoints in patients with obstructive lung diseases, finalize the MagniXene™ dosing and MRI methods, and validate the MagniXene™ results by comparing with the existing clinical methods for assessing lung function and microstructure. We selected the two most mature and promising MagniXene™ techniques for inclusion in this Phase 2 trial: ventilation and diffusion imaging.
Obstructive lung diseases such as COPD and asthma have been shown to have regional abnormalities of ventilation and these abnormalities are prime targets for intervention. Thus our first aim is to validate MagniXene™ MRI for the intended use of delineating ventilated and unventilated regions of the lung in COPD and asthma patients. For our Phase 2a trial we will compare MagniXene™ ventilation MRI and 99Tc DTPA ventilation scintigraphy (a clinical standard for assessing regional lung ventilation) in 10 healthy volunteers and 70 patients with COPD and asthma. In addition to the patient safety data, we will assess total lung volume and ventilated lung volume on MRI, and the congruence of ventilated volume boundaries between MagniXene™ MRI and scintigraphy.
Our second aim is to validate MagniXene™ diffusion MR for the intended use of quantifying alveolar enlargement in emphysema, a fundamental abnormality that currently is assessed only by histology. Recently completed pilot studies show that hyperpolarized helium diffusion imaging with six b-values can separately determine diffusion coefficients along and transverse to acinar ducts, which are related to alveolar depth and duct diameter. For our Phase 2b trial we will perform diffusion MagniXene™ MRI in vivo in 18 COPD patients scheduled for lung transplant, and repeat the scan in the ex-vivo lung after it is removed, thereby establishing that in vivo and ex vivo MagniXene™ measurements are concordant. The final step in the validation of the MagniXene™ diffusion measurement is to regionally compare alveolar size with morphometric measurements via histology from the explanted lung. The completion of the proposed work represents a significant advancement towards commercialization of MagniXene™.
