Irinotecan given by IV is an anticancer agent that is used widely in the treatment of colorectal, lung, ovarian, cervical, pancreatic, upper gastrointestinal and brain cancer. In the product label for Camptosar (irinotecan), a variety of dosing regimens are approved for therapeutic use in metastatic colorectal cancer, including 350 mg/m² given once every 3 weeks, weekly regimens of 125 mg/m², and 180 or 240 mg/m² every 2 weeks. The main objective supporting these dosing schedules has been to establish the highest dose possible that would lead to disruption of tumor growth, while allowing the bone marrow to recover from the chemotherapy induced toxicity. Oratecan has been studied in combination with capecitabine in solid tumors in Korea and a Phase 1 study for Oratecan is well underway in solid tumors in the U.S. These Phase 1 studies have been successful in identifying a dosing regimen suitable for a Phase 2 study, which we are planning to initiate in the first half of 2019.

Clinical Trial Pipeline

Oratecan Territory Indication Sponsor/Partner Pre-Clinical Phase I Phase II Phase III
HM-OTE-101 South Korea Solid Tumor Hanmi
Completed
HM-OTE-102 South Korea Solid Tumor Hanmi
Completed
HM-OTE-103 South Korea Solid Tumor Hanmi
Completed
ORTE-01-14-US United States Solid Tumor Athenex
Ongoing
KX-ORTE-001 New Zealand Solid Tumor Athenex/Zentech
Planned Q1/2019
KX-ORTE-TBD TBD TBD Athenex
Planned 1H/2019