Ascelia Pharma

The publication titled ‘Lesion Visualization of an Oral Manganese Contrast Agent Compared to Unenhanced MRI and Gadobenate Dimeglumine in Patients Undergoing Liver Magnetic Resonance Imaging for Evaluation of Colorectal Cancer Metastases Centralized Assessment of a Randomized, Crossover, Phase II Study’, presents the outcomes of a Phase II study previously conducted at Karolinska Institute utilizing the same independent reader methodology and approach as the Phase III SPARKLE study with Orviglance.
 
In this 20-patient study, Orviglance enhanced MRI resulted in statistically significant superior visualization and a greater number of detected focal liver lesions than unenhanced. Orviglance and gadobenate dimeglumine performed similarly in the visualization and detection of the lesions.
 
The publication is co-authored by Torkel Brismar, MD, PhD and Nikolaos Kartalis MD, PhD from the Department of Radiology, Karolinska University Hospital, Stockholm.
 
“The publication of this data in one of the leading journals in radiology demonstrates the interest in the medical and scientific community for Orviglance and its potential for clinical application. This recognition of our progress and results so far is key as we prepare to submit for regulatory approval and subsequent commercialization” said Andreas Norlin, CSO of Ascelia Pharma.
 
The publication is available online and will be in a printed issue of the journal later this year.
 
Ascelia Pharma expects to submit the New Drug Application (NDA) file for Orviglance to the US Food and Drug Administration (FDA) by mid-2025 to obtain regulatory approval.