Medical

Diagnostics | Therapeutics

Diagnostics

Luna's nanoWorks division is investigating various applications in nanomedicine with a focus on Magnetic Resonance Imaging, or MRI, a non-invasive diagnostic procedure that enables physicians to visualize organs, soft tissues, bone and virtually all other internal body structures through magnetic interactions. MRI does not use ionizing radiation (x-rays). These medical imaging procedures are enhanced by the use of contrast agents to further improve diagnosis. Click here to learn more about how MRI works.

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 and which potentially safer than current MRI agents using a new class of metal atoms Luna calls HYDROCHALARONE™. 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 with 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 publishings suggesting that cancer may be developing in some patients as a result of exposure to excessive x-rays and gamma rays through diagnostic procedures such as computed tomography (CT), also referred to as CAT scans. 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 possibilties 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.

Therapeutics

The practice of medicine is shifting to molecular therapies requiring next-generation diagnostics and therapeutics. The HYDROCHALARONE™ 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 the HYDROCHALARONE™ is the development of a portfolio of nanomedicines aimed at disease targeting and diagnostic imaging.

Luna's program in nanomedicine is focused on using proprietary antioxidant technology to identify therapeutic candidates that are targeted with nanometer-scale precision to sites where pathogenic free radicals are produced. A free radical is a molecule that has an uneven number of electrons which causes it to become reactive. The reactive molecule may attach to another molecule which is an important cell component. Free radicals are often beneficial, but, under stress, they can overwhelm the natural antioxidants present inside cells and attach to critical elements. Sometimes this starts a chain reaction that can harm the cells and may be responsible for numerous age-related diseases. Antioxidants are used to intercept free radicals and neutralize them before they cause harm. Luna is developing novel pharmaceuticals targeted to specific diseases where no other antioxidants have been effective.

Luna recently discovered its nanomedicine prototype aids in the growth of new hair follicles. Hair growth is a process that normally depends on the regeneration of tiny hair follicles. Hairless mice have a mutation that results in atrophy of hair follicles a few weeks after birth. The hair does not regenerate. The gene responsible for the mutation in the hairless mice has been identified, however the biological processes that cause the follicle to atrophy are not well understood. In addition to hair loss due to heredity, Luna's discovery may also aid in hair regeneration for loss due to other medical conditions.

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