Ascelia Pharma

The results from the Hepatic Impairment Study were presented at the ESGAR Annual Meeting, with a poster titled Safety and signal intensity of a novel liver-specific MRI contrast agent, Orviglance® (manganese chloride tetrahydrate), in adult subjects with mild, moderate, or severe hepatic impairment.

As previously communicated, the results of the Hepatic Impairment Study showed that Orviglance is well tolerated in patients with liver (hepatic) impairment, with only mild to moderate transient, gastrointestinal adverse events reported, such as nausea. No new safety concerns were identified. The data confirmed there was no renal excretion of Orviglance, and that excretion is primarily occurring via the liver also in this subgroup of patients. The data suggest that Orviglance can be used in patients with any degree of hepatic impairment.

Ascelia Pharma also hosted a Q&A session during ESGAR with two experts in liver imaging, Dr. Nikolaos Kartalis of Department of Radiology Huddinge, Karolinska University Hospital, and Dr. Alessandro Furlan of Radiology, Abdominal Imaging Division of University of Pittsburg Medical Center.

“We are honored to have been given the opportunity to chair this debate on liver imaging and unmet needs for patients with two of the leading key experts in liver imaging and to share with the medical community that Orviglance has the potential to also be used in patients with any degree of hepatic impairment, said Julie Waras Brogren, Deputy CEO and CCO of Ascelia Pharma. “These are part of the steps preparing us for launching Orviglance. The first step is our headline results from SPARKLE, the pivotal Phase 3 study for Orviglance. We are on track for announcing results during the middle of this year,” she continued.

In the Q&A session, moderated by Director of Global Medical Affairs at Ascelia Pharma, Dr. Nadilka Hettiarachchige, Dr. Kartalis and Dr. Furlan discussed the role of liver imaging in cancer care, the clinical practice for patients with severe kidney impairment and the trends ahead.

“With the improvement of the treatment and introduction of new treatment methods… we have a tendency to see these patients quite often. So, we follow these patients; we see them many times”, said Dr. Kartalis.

Dr. Furlan added: “It’s not infrequent to find patients that on top of having metastatic disease also have impaired renal function. In my institution, for patients that have reduced renal function, we would reduce the amount of gadolinium that we inject, since we still do not have an alternative - a non-gadolinium-based contrast agent that we can use”, and continued “we don’t have that yet in the market, but it would certainly be a great tool to have in our box”.

The video is available on the website of Ascelia Pharma at https://www.ascelia.com/ along side our updated company presentation.