The Phase III trial has been designed as a global, randomized, multi-center open label trial to prospectively evaluate the safety and efficacy of Karenitecin compared to the chemotherapy drug topotecan (also known as Hycamtin). Either Karenitecin or topotecan will be given intravenously daily for five consecutive days repeated every three weeks to advanced ovarian cancer patients who have previously been treated with platinum and taxane chemotherapy drugs but have become resistant to the platinum/taxane therapy.
Frederick Hausheer, BioNumerik’s chairman and CEO, said: “Based on the Phase II outcomes and our preclinical data, we are pursuing Karenitecin Phase III testing in advanced ovarian cancer patients who have become resistant to platinum/taxane chemotherapy.”