Abstract for Orviglance comparison study to gadolinium accepted at the world’s largest radiology conference RSNA

2021-08-13
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Ascelia Pharma AB (publ) (ticker: ACE) today announced that the study where Orviglance® (manganese chloride tetrahydrate, former working name Mangoral) was compared against a gadolinium-based specific contrast agent has been accepted as an oral paper presentation at the world’s largest radiology conference RSNA. The conference will be held November 28 – December 3 in Chicago, Illinois.

In December 2020, Ascelia Pharma announced the results of a comparison study versus a gadolinium contrast agent. The results showed that Orviglance enhanced MRI was as effective as the gadolinium contrast agent gadobenate dimeglumine (Multihance) in terms of visualization of lesions and number of detected lesions detection. In fact, 2 out of the 3 independent readers reported higher scores for Orviglance enhanced MRI. The results also showed that Orviglance enhanced MRI provides improved diagnostic efficacy compared to MRI without a contrast agent using identical endpoints as in the ongoing pivotal Phase 3 study SPARKLE.

“We are very pleased that the study has been selected as an oral paper presentation at the prestigious radiology conference RSNA. The study provides a robust evidence of the diagnostic value that Orviglance can offer once available to patients and physicians. Orviglance is being developed to address the unmet medical need of patients with poor kidney function, and it is encouraging that Orviglance* is as effective as a gadolinium contrast agent, said Carl Bjartmar, Chief Medical Officer at Ascelia Pharma.
 
*Trademark is registered in Europe and several other markets and submitted for registration in the US.