MedicalDiagnostics | Therapeutics
MRI has revolutionized the physicians' ability to diagnose certain disorders effectively. The MRI contrast agent market is reported to be more than $1 billion annually and is currently dominated by gadolinium chelate-based agents. There is growing concern over chelate-based agents due to their potential to release the gadolinium from the chelate after administration. In today’s agents, the gadolinium is formulated in a chelate to prevent toxicity. The chelate binds around the gadolinium preventing toxicity. The chelate agent is designed to be in the body for a short period of time, and is cleansed through renal elimination. In kidney disease, the cleansing system slows down, allowing the chelate and the gadolinium to separate, which exposes the patient to the toxic metal molecule.
The U.S. Food and Drug Administration (FDA) has been reviewing reports about patients who have developed a new disease after receiving a chelate-based contrast agent. This debilitating disease, known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD), may affect the skin, muscles and internal organs and can cause death. The FDA has issued a black-box warning to heighten awareness about the risk of NSF/NFD, particularly in patients with kidney and liver problems. Read more on the FDA Web site.
Luna has produced and demonstrated a prototype contrast imaging agent designed to be more effective at enhancing images. Using a new class of contrast agents called HYDROCHALARONE™ nanomaterials makes Luna’s contrast imaging prototype potentially safer than current MRI agents. Luna's HYDROCHALARONE completely encapsulates the metal molecules, indicating it may eliminate the toxicity currently associated with gadolinium chelate-based agents. Additionally, HYDROCHALARONE has a relaxivity higher than current agents available today (the level of relaxivity is the characteristic of molecules that provides the image enhancement). Higher relaxivity means a quality image can be obtained using less HYDROCHALARONE. See the release Luna Innovations Successfully Demonstrates MRI Contrast Agent.
MRI is also being investigated as an alternative technology in settings where ionizing radiation is currently used. There are recent publications suggesting that cancer may be developing in some patients as a result of exposure to excessive gamma- and x-rays through diagnostic procedures such as nuclear medicine and Computed Tomography (CT), also known as CAT scans, respectively. A paper in the New England Journal of Medicine estimated that 2% of cancers are caused by diagnostic procedures that use ionizing radiation. This is a highly controversial issue as noted by the American College of Radiology.
Luna is exploring the possibilities of using its contrast agents in areas where MRI has not been used previously. Luna was recently awarded funding from the National Heart, Lung, and Blood Institute to develop a new diagnostic agent that could improve the diagnosis of coronary artery disease, or CAD, a condition that causes most heart attacks. Currently, CAD is most-commonly diagnosed through an invasive procedure known as cardiac catheterization angiography. Luna is investigating HYDROCHALARONE™ derivatives which may provide images of plaque buildup in the arterial walls of the heart. Read more here.
The practice of medicine is shifting to molecular therapies requiring next-generation diagnostics and therapeutics. HYDROCHALARONE™ molecules could offer a platform technology that may lead to the identification of a portfolio of new MRI agents, which could be targeted to provide specific diagnostic information about diseases. Targeted agents would dramatically change the settings where MRI could be used. Luna is getting the tools in place to lead this medical shift. Luna's HYDROCHALARONE has been selected for preclinical studies and a collaboration with National Cancer Institute's Nanotechnology Characterization Laboratory (NCL). The end goal of Luna's product development effort with HYDROCHALARONE™ carbon nanomaterials is the development of a portfolio of nanomedicines aimed at disease targeting and diagnostic imaging.