Ascelia Pharma has announced the publication of a Phase II study in Investigative Radiology demonstrating that its orphan drug candidate Orviglance® significantly improves liver lesion detection compared to unenhanced MRI scans. The study, conducted at Karolinska Institute in Stockholm, evaluated the oral manganese contrast agent in patients undergoing liver MRI for colorectal cancer metastases.
The 20-patient randomized, crossover study utilized the same independent reader methodology as Ascelia's ongoing Phase III SPARKLE trial. Results showed that Orviglance-enhanced MRI achieved statistically significant superior visualization and detected more focal liver lesions than unenhanced MRI. Importantly, Orviglance performed similarly to gadobenate dimeglumine, a gadolinium-based contrast agent, in both visualization and detection capabilities.
"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," said Andreas Norlin, CSO of Ascelia Pharma. "This recognition of our progress and results so far is key as we prepare to submit for regulatory approval and subsequent commercialization."
Clinical Significance for Patients with Kidney Impairment
Orviglance represents a potential breakthrough for patients with severely reduced kidney function who need liver MRI imaging. Currently, gadolinium-based contrast agents (GBCAs) are contraindicated or used with caution in these patients due to the risk of nephrogenic systemic fibrosis, a rare but serious condition.
As an oral manganese-based alternative, Orviglance could fill a significant unmet medical need. The contrast agent is designed specifically for patients where gadolinium-based agents may be medically inadvisable, offering improved visualization without the associated risks.
Study Details and Methodology
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," was co-authored by Torkel Brismar, MD, PhD and Nikolaos Kartalis MD, PhD from the Department of Radiology at Karolinska University Hospital.
The crossover design allowed for direct comparison between imaging modalities within the same patient population, strengthening the validity of the findings. The study employed centralized assessment to ensure consistent evaluation of lesion detection and visualization quality.
Regulatory Pathway and Commercial Outlook
Ascelia Pharma expects to submit a New Drug Application (NDA) for Orviglance to the US Food and Drug Administration by mid-2025. The orphan drug designation previously granted to Orviglance provides certain benefits, including market exclusivity upon approval.
The company, headquartered in Malmö, Sweden, is focused on developing treatments for rare cancer conditions. With Orviglance and another candidate, Oncoral, in its pipeline, Ascelia aims to address significant unmet medical needs in oncology.
The full publication is currently available online and will appear in a printed issue of Investigative Radiology later this year, further validating the scientific rigor behind Orviglance's development program.
