Pipeline

Our lead candidate Mangoral is a liver imaging drug (i.e. a liver specific contrast agent) being developed for detection and localization of potential liver metastases, using Magnetic Resonance Imaging (“MRI”) in patients where use of the current gold standard gadolinium-based contrast agents (“GBCAs”) may be medically inadvisable or cannot be administered. Mangoral is currently ready for Phase III clinical development.

Our second drug candidate Oncoral is a novel tablet-based formulation of the well-known chemotherapeutic agent irinotecan, intended for the treatment of advanced gastric (stomach) cancer. Irinotecan is today mainly used for treating metastasized colorectal cancer. Although irinotecan is currently not approved for treating gastric cancer in the United States and in the EU, there is off-label use for this indication. Oncoral is currently being evaluated in an investigator sponsored Phase I study.

Mangoral

Our lead candidate Mangoral is a liver imaging drug (i.e. a liver specific contrast agent) being developed for detection and localization of potential liver metastases, using Magnetic Resonance Imaging (“MRI”) in patients where use of the current gold standard gadolinium-based contrast agents (“GBCAs”) may be medically inadvisable or cannot be administered. Mangoral is currently ready for Phase III clinical development.

Oncoral

Oncoral is a novel tablet-based formulation of the well-known chemotherapeutic agent irinotecan, intended for the treatment of advanced gastric (stomach) cancer. Irinotecan is today mainly used for treating metastasized colorectal cancer. Although irinotecan is currently not approved for treating gastric cancer in the United States and in the EU, there is off-label use for this indication. Oncoral has completed Phase I studies with encouraging results and is ready for Phase II studies.

DEVELOPMENT PLAN

Ascelia has established a development program for lead candidate Mangoral, consisting of a pivotal Phase III efficacy study and two supportive studies. The clinical development strategy for Oncoral, Ascelia´s second drug candidate, is to obtain Phase II data and then to partner for the further development.