Contrast agents used in MRI scans to improve the clarity of imaging for diagnostic accuracy, accumulate in the brain and body of every patient, and carry an FDA “black box” warning about gadolinium, a heavy metal they use to generate contrast. Now, a revolutionary gadolinium-free contrast agent, RVP‑001, designed to provide safer contrast-enhanced MRIs for patients and to directly replace current MRI contrast agents, is being tested for the first time in a clinical trial. Reveal Pharmaceuticals has dosed the first subjects in the Phase 1 clinical trial of RVP‑001.
“The start of clinical trials is a tremendous milestone in advancing patient care,” said Vera Hoffman, CEO of Reveal. “Despite years of effort, this is the first time a general-purpose gadolinium-free contrast agent has been innovated and clinically tested.”
The Phase 1 study is designed to determine the safety, tolerability, and pharmacokinetics of RVP‑001. Each year over 40 million contrast-enhanced (CE) MRI scans are used to diagnose and manage many serious health conditions. Gadolinium used in CE‑MRI scans not only impacts patients with buildup of the heavy metal in the brain and body, but also impacts the environment by driving rising levels of gadolinium in the earth’s surface waters. Instead of gadolinium, RVP‑001 uses manganese, which is essential for life and naturally found in the body.
RVP‑001 was invented by Peter Caravan and Eric Gale at Harvard Medical School / Massachusetts General Hospital. The National Cancer Institute, part of the National Institutes of Health, is funding the US-based clinical trial.
“RVP‑001 promises to directly replace gadolinium-based contrast agents and use established radiology protocols developed over decades of CE-MRI,” said Srinivasan Mukundan, Reveal’s medical director and former chief of MRI and Neuroradiology at Brigham Health. “Physicians and patients increasingly avoid CE-MRI due to concerns about gadolinium. Gadolinium-free RVP‑001 allays these concerns and provides promise for patients to receive the imaging studies they need.”
[Source(s): Reveal Pharmaceuticals, GlobeNewswire; image courtesy of GlobeNewswire]