BioNumerik Commences Ovarian Cancer Trial On Karenitecin

BioNumerik Pharmaceuticals initiates global Phase III clinical trial of BioNumerik's anticancer drug candidate known as Karenitecin in advanced ovarian cancer patients. BioNumerik is developing Karenitecin (also known as BNP1350) as an investigational new anti-tumor drug in the camptothecin class of chemotherapy drugs. Based on prior studies, BioNumerik believes Karenitecin has the potential for fewer side-effects, better efficacy, and less susceptibility to drug resistance mechanisms compared to the currently marketed camptothecin drugs.

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 5 consecutive days repeated every 3 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. BioNumerik has received written agreement from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) regarding the clinical trial design and protocol.

Four Phase II clinical trials of intravenously administered Karenitecin have been completed in the U.S. in patients with advanced ovarian cancer, metastatic malignant melanoma, advanced non-small cell lung cancer, and primary brain tumors. BioNumerik has also initiated a Phase I clinical trial to evaluate the safety and effectiveness of an orally administered Karenitecin formulation. Based on prior studies, BioNumerik believes Karenitecin may have the following potential advantages over currently marketed camptothecins:

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