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Thursday 07 February 2008

BioNumerik begins Phase III ovarian cancer trials on new drug

By: San Antonio Business Journal

BioNumerik Pharmaceuticals Inc. on Thursday said the first patient has begun treatment in a global Phase III clinical trial of BioNumerik's anticancer drug candidate, known as Karenitecin, in advanced ovarian cancer patients.

 The San Antonio-based company is developing the anticancer drug as an investigational anti-tumor drug in the camptothecin class of chemotherapy drugs. Based on studies, BioNumerik believes Karenitecin has the potential for fewer side effects and less susceptibility to drug resistant mechanisms.

The Phase III trial will compare Karenitecin with the chemotherapy drug topotecan (Hycamtin). Either drug can be given intravenously to advanced ovarian cancer patients who have become resistant to platinum and taxane chemotherapy drugs. Four Phase II and one Phase I clinical trials already have been completed in the United States involving the drug.

"There is a large unmet need for second- and third-line therapies that can prevent the progression of recurrent or progressive ovarian cancer with reduced risk of cumulative toxicity in patients who have become resistant to platinum/taxane-based chemotherapy," says Frederick H. Hausheer, M.D., BioNumerik's chairman and CEO.

BioNumerik believes Karenitecin can lower the incidence of severe diarrhea, anemia and neutropenia (reduction in white blood cell counts) compared to other drugs on the market.

BioNumerik develops and commercializes novel drugs for the treatment of cancer and cancer supportive care. The company currently has two drug candidates, Karenitecin and Tavocept, in late-stage clinical development.

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