Oncoral

Oncoral is a tablet formulation of the topoisomerase I inhibitor irinotecan, a chemotherapeutic drug with a well-established role in the treatment of cancer.

 

Most chemotherapeutic drugs are given intravenously over several minutes, but some may require hospitalization for 2 days or more. Intravenously administered chemotherapy is inconvenient for patients, adversely affecting the quality of life. Intravenously administered chemotherapy can be associated with significant toxicities, psychological distress, medical complications and prolonged hospital stays. Moreover, hospitalization expenses are a main chemotherapeutic cost driver, especially due to requirement for continuous infusion.

Oral chemotherapeutic drugs potentially offer a wide number of advantages, including greater convenience, fewer hospital/doctor’s office visits, less pain, better safety profile and the avoidance of problems related to venous access.

Irinotecan is a prodrug which is converted by nonspecific carboxylesterases into SN-38, a 100- to 1000-fold more active metabolite. The intravenously administered chemotherapeutic drug irinotecan is often used in combination with other chemotherapeutic agents, and it is approved in the US and EU for treatment of metastatic colorectal cancer.

One of the most widely used irinotecan regimens is in combination with another chemotherapeutic drug, 5-Fluorouracil, administered intravenously as the FOLFIRI regimen. 5-Fluorouracil (5-FU) is also available in oral formulations, and thus Oncoral has the potential to be administered as part of an all-oral chemotherapy tablet regimen similar to the intravenous FOLFIRI regimen.

Oncoral is intended as a patient friendly orally administered drug for the treatment of advanced gastric cancer in combination with other anti-cancer treatments.

Gastric cancer is a serious disease with a large unmet medical need (it is the third leading cause of cancer death in both sexes worldwide). In western countries, most patients are diagnosed at an advanced stage or have disease relapse within 5 years. The 5-year survival of gastric cancer is only around 20% and the median survival of advanced disease with combination chemotherapy has been reported to be less than one year.

Since the mechanism of action of irinotecan is inhibition of topoisomerase I, a validated anti-cancer concept, Oncoral also has the potential to fulfill unmet medical needs in selected patient segments in various other cancer indications. The additional indications to be considered for Oncoral will be based on several factors, including the results of the clinical development in gastric cancer.

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.