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 is 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.