The investigational agent, mangaciclanol, is being developed as an alternative to gadolinium-based contrast agents and has received FDA Fast Track designation.
GE HealthCare has dosed the first patient in its Phase 2/3 LUMINA clinical trial for mangaciclanol, a manganese-based magnetic resonance imaging (MRI) contrast agent. The company announced that the international, multi-center trial initiated dosing at Mayo Clinic in Rochester, Minnesota.
If approved, mangaciclanol could provide an alternative to gadolinium-based contrast agents, the current standard of care. The investigational agent has been granted Fast Track designation by the US Food and Drug Administration (FDA) for use in adults and pediatric patients aged 2 years and older to detect and visualize lesions with abnormal vascularity.
An Alternative to Gadolinium
MRI contrast agents are used to enhance the visualization of abnormal structures and help clinicians distinguish between healthy and diseased tissue. According to GE HealthCare, mangaciclanol is intended for general-purpose MR imaging and demonstrates relaxivity comparable to the gadolinium-based agent gadobutrol, with early clinical images suggesting similar diagnostic capability.
The development of a manganese-based agent aims to address concerns associated with gadolinium, a rare-earth metal. These include gadolinium retention in the body, supply chain vulnerabilities linked to mining infrastructure, and potential environmental impacts from post-patient excretion. In contrast, manganese is an endogenous element naturally regulated by the body. The company states that the macrocyclic structure of mangaciclanol is designed to lessen the possibility of retention.
Phase 1 trial results showed the agent was well tolerated, with no serious adverse events, dose-limiting toxicities, or clinically relevant findings reported.
“Existing gadolinium-based contrast agents carry safety language associated with gadolinium retention. In comparison, mangaciclanol could offer an alternative for broad patient groups, including vulnerable patients and those requiring multiple scans, while still offering similar diagnostic performance,” says Dr Jit Saini, chief medical officer, pharmacutical diagnostics, GE HealthCare, in a release. “The FDA Fast Track designation recognizes the potential significance of mangaciclanol and aligns with our focus on advancing its development for patients.”
Addressing Market and Supply Needs
Approximately one-third of global MRI procedures, or around 65 million scans annually, require a contrast agent for diagnosis, according to the company. The supply of gadolinium is largely dependent on a few countries, while manganese is more abundantly available, potentially reducing the risk of supply challenges.
“As demand for diagnostic imaging continues to rise, we continue to advance our imaging agent pipeline to better meet the needs of patients,” says Peter Arduini, President and CEO, GE HealthCare, in a release. “This clinical milestone builds on GE HealthCare’s leadership in contrast media, as mangaciclanol has the potential to transform the MR imaging market and strengthen the resiliency of its supply chain.”
Mangaciclanol is currently in clinical development and is not approved for use.
Photo caption: Imaging depicting the use of mangaciclanol
Photo credit: GE HealthCare
