US cancer drug and supportive care specialist BioNumerik Pharmaceuticals says it has treated the first patient in a Phase III trial of karenitecin (BNP1350), its candidate product for women with advanced ovarian cancer. The firm noted that the compound, a member of the camptothecin class of chemotherapy agents, offers a potential reduction in side effects and may be less susceptible to resistance mechanisms than currently-available therapies.
The Phase III trial, which is being run as a global, randomized, multicenter, open-label assessment, is designed to compare the safety and efficacy of karenitecin with Hycamtin (topotecan; made by GlaxoSmithKline). Women enrolled in the program, all of whom have received prior platinum and taxane-based chemotherapy, will receive one of the two drugs, intravenously for five consecutive days, every three weeks.
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