30 November 2022: Ascelia Pharma AB (publ) – a biopharmaceutical company focused on improving the life of people living with rare cancer conditions – is presenting results from its Orviglance* Food Effect study at the RSNA conference 2022– 27 November – 1 December Chicago, Illinois). The study evaluates the effect of food intake on the absorption and signal intensity of Orviglance, a manganese-based MRI contrast agent, and successfully concludes that image enhancement is not impacted by a light meal.
The Food Effect Study results show that intake of a light meal within 30 min prior to Orviglance administration provides similar image MRI enhancement of the liver compared to a fasting condition. In line with previous studies, the data also confirms strong image enhancement of the liver after Orviglance administration compared to an MRI image without a contrast agent. In clinical practice, the results support administration of Orviglance both after fasting or after consumption of a light meal.
The reporting of these final results for the Food Effect Study completes two of the three studies in Ascelia Pharma’s ongoing Phase 3 clinical program for registration of Orviglance. As previously announced, the Hepatic Impairment Study successfully concluded that Orviglance is well tolerated in patients with liver (hepatic) impairment. The plan for the ongoing Phase 3 study, SPARKLE, required for regulatory submission, is to complete patient enrolment by the end of this year.
Magnus Corfitzen, CEO at Ascelia Pharma, said: “We are very pleased to be presenting the study as an oral presentation at the Radiological Society of North America’s radiology conference, RSNA. The possibility for omitting a fasting condition improves the convenience for patients and eases the administration of Orviglance in clinical practice. Orviglance is being developed to address the unmet medical need of patients with poor kidney function who require liver imaging, and it is very encouraging that the study results support previous findings on the ability of Orviglance to provide strong image enhancement to liver MRI scans.”
Data from the Food Effect Study will be included in the marketing authorization application to health authorities, including FDA and EMA.
The Orviglance Food Effect study will be presented by Dr. Kohkan Shamsi at the RSNA on Wednesday, 30 November 2022 at 3,00pm ET.
For more information, visit www.ascelia.com.