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BioNumerik Commences Global Phase III Ovarian Cancer Trial on Novel Anticancer Drug Candidate Known as Karenitecin(R)

SAN ANTONIO, Feb. 7 /PRNewswire/ -- BioNumerik Pharmaceuticals, Inc. today announced treatment of the first patient in a global Phase III clinical trial of BioNumerik's anticancer drug candidate known as Karenitecin(R) 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(R)). 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:
-- Comparable or improved effectiveness in the treatment of certain

cancers, with a potentially improved safety profile and fewer of the

dose-limiting side-effects caused by camptothecin drugs including:

- lower incidence of severe diarrhea than that caused by irinotecan

(also known as Camptosar(R));

- lower incidence of anemia and neutropenia (reduction in white blood

cell counts), than that caused by topotecan (also known as


-- Less susceptibility than currently marketed camptothecins to common

drug resistance mechanisms found in many types of human cancer cells,

including resistance mechanisms that are specific to the camptothecin

class; and

-- Because Karenitecin is lipophilic (fat loving), BioNumerik believes

Karenitecin may have enhanced tissue penetration, drug delivery and

bioavailability compared to existing water soluble camptothecins.

In commenting on these developments, Frederick H. Hausheer, M.D., BioNumerik's Chairman & Chief Executive Officer stated: "There is a large unmet need for 2nd and 3rd -line therapies that can prevent progression of recurrent or progressive ovarian cancer with reduced risk of cumulative toxicity in patients who have become resistant to platinum/taxane-based chemotherapy. Ovarian cancer is difficult to diagnose early and patients are usually diagnosed with advanced disease (Stage III or IV). Outcomes for patients with advanced ovarian cancer remain poor. Up to 80% of ovarian cancer patients who initially respond to treatment will ultimately relapse and require additional therapy, and treatment options for patients with advanced recurrent ovarian cancer are limited. In addition, all approved agents for the treatment of advanced ovarian cancer are associated with significant toxicity that can be dose-limiting."

Dr. Hausheer added, "We believe the safety and efficacy outcomes from the previously completed Karenitecin Phase II advanced ovarian cancer trial compare favorably with the historically reported results of approved agents. Based on the Phase II outcomes and our pre-clinical data, we are pursuing Karenitecin Phase III testing in advanced ovarian cancer patients who have become resistant to platinum/taxane chemotherapy."

About BioNumerik:

BioNumerik Pharmaceuticals, Inc., based in San Antonio, Texas, is focused on the discovery, development and commercialization of novel drugs for the treatment of cancer and cancer supportive care. The Company currently has two drug candidates, Karenitecin(R) and Tavocept(TM), in late-stage clinical development. BioNumerik has eight additional drug discovery research programs, and has generated a patent portfolio of more than 450 patents and pending patent applications worldwide.

Editor's Note: This release is also available on the Internet at:


David R. Margrave

BioNumerik Pharmaceuticals, Inc.

(210) 614-1701


SOURCE BioNumerik Pharmaceuticals, Inc.
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