Policy & Regulation
Ascelia Pharma AB reports first patient enrolled in pivotal phase III clinical study SPARKLE with lead candidate Mangoral
20 February 2020 -

Ascelia Pharma AB (STO:ACE) , an oncology-dedicated orphan drug development company, announced on Wednesday the enrolment of the first patient in the company's global pivotal phase III clinical study SPARKLE with Mangoral in patients with severely reduced renal function and with known or suspected liver lesions.

Reportedly, Mangoral is the first oral imaging drug being developed for liver MRI. Mangoral is covered by an Orphan Drug Designation in the US, targeting the unmet need in patients who cannot tolerate currently marketed contrast agents due to impaired kidney function.

SPARKLE is a global multicentre, registration-enabling study of Mangoral in up to 200 patients with severely reduced renal function and with known or suspected liver lesions. Ascelia Pharma expects full study report in the first half of 2021.

According to the company, this study aims to demonstrate the efficacy and safety of Mangoral in terms of improved lesion visualisation, as compared to unenhanced MRI, with each patient being their own control subject. Primary efficacy, in terms of lesion visualisation compared to unenhanced MRI, will be evaluated by three independent blinded readers.

Also, MRI will be performed before and shortly after oral Mangoral administration, and basic safety parameters will be evaluated for five days following administration.

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