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BioNumerik Commences Global Phase III Ovarian Cancer Trial on Novel Anticancer Drug Candidate Known as Karenitecin(R)
Date:2/7/2008

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

Hycamtin(R));

-- 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
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SOURCE BioNumerik Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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