OverviewWe are developing Karenitecin® (also known as BNP1350) as an investigational new anti-tumor drug in the camptothecin class of chemotherapy drugs. We are currently conducting an international Phase III clinical trial of Karenitecin® in advanced ovarian cancer patients.
We believe that Karenitecin has the potential for fewer side-effects, improved efficacy, less susceptibility to drug resistance mechanisms and an improved safety profile compared to the currently marketed camptothecin drugs. Based on prior studies, we believe Karenitecin has a lower incidence of severe diarrhea than that caused by the marketed camptothecin drug irinotecan (Camptosar®, Pfizer), and a lower incidence and severity of anemia, neutropenia and thrombocytopenia than that caused by the marketed camptothecin drug topotecan (Hycamtin®, GlaxoSmithKline).
Irinotecan and topotecan, the only FDA-approved camptothecins, are used for the treatment of patients with colorectal, small cell lung, ovarian and cervical cancers. We believe Karenitecin® may have the following advantages over these drugs:
- Improved effectiveness in the treatment of certain cancers, with a potentially improved safety profile and fewer of the dose-limiting side-effects caused by other camptothecin drugs including:
- lower incidence of severe diarrhea than that caused by irinotecan;
- lower incidence of grade 3 or grade 4 anemia, neutropenia and thrombocytopenia than that caused by topotecan.
- Potential oral administration, due to Karenitecin’s high oral bioavailability (> 40%), making Karenitecin more convenient for patients and physicians.
- Less susceptibility than currently marketed camptothecins to common drug resistance mechanisms found in many types of human cancer cells, including those that are specific to the camptothecin class.
Ongoing Karenitecin Phase III Trial in Advanced Ovarian Cancer.
Camptothecins and Their Limitations.
Addressing the Clinical Limitations of Camptothecins.
Additional Ongoing Karenitecin Trials.
Prior Phase II Karenitecin Clinical Trials.
Potential Additional Karenitecin Development Areas.