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Product Candidates

BioNumerik Pharmaceuticals, Inc. Feature

Karenitecin®

Overview

We are developing Karenitecin® (also known as BNP1350) as an investigational new anti-tumor drug in the camptothecin class of chemotherapy drugs. Our current development focus for Karenitecin is in the area of patients with advanced ovarian cancer.

We believe that Karenitecin has the potential for fewer side-effects, improved efficacy, less susceptibility to drug resistance mechanisms and an improved safety profile compared to currently marketed camptothecin drugs.

The potential for oral administration, due to Karenitecin’s high oral bioavailability (> 40%), coupled with Karenitecin’s substantially reduced susceptibility to common drug resistance mechanisms found in many types of human cancer cells, including those that are specific to the camptothecin class, are important components to consider in the development of the drug candidate. We believe these characteristics could make Karenitecin more convenient for patients and physicians.

Completed Karenitecin Phase III Trial in Advanced Ovarian Cancer

We have completed an international multi-center Phase III clinical trial of Karenitecin in patients with advanced epithelial ovarian cancer (the “Karenitecin Phase III Ovarian Trial”). This Phase III clinical trial evaluated the potential of Karenitecin compared to the currently marketed drug topotecan (also known as Hycamtin®) in platinum- and taxane-refractory or resistant advanced epithelial ovarian cancer patients. Although an improvement in median progression-free survival (PFS) in favor of Karenitecin was observed in the study, the results were not statistically significant.

Analysis of subgroups from the Karenitecin Phase III Ovarian Trial indicated notable findings in the Resistant and Mucinous subgroups of the overall advanced ovarian cancer population. Based on these observations, we are evaluating potential additional development opportunities for Karenitecin in these treatment areas.

We believe there is a large unmet need for 2nd and 3rd -line therapies that can prevent progression or recurrence of progressive ovarian cancer with reduced risk of cumulative toxicity in patients who are resistant to platinum/taxane-based chemotherapy. In addition, the Mucinous subtype of ovarian cancer represents a currently unaddressed indication where no effective treatment exists. We believe that Mucinous ovarian cancer would represent a potential treatment indication for Karenitecin in a rare disease area that is unmet by current therapy.

Addressing the Clinical Limitations of Camptothecins

Karenitecins, a class of camptothecins discovered and developed by BioNumerik, have several potentially useful features, including broad anticancer activity, favorable metabolism and substantially reduced sensitivity to common tumor-mediated drug resistance mechanisms.

Like most other naturally occurring camptothecins, karenitecins are poorly water-soluble. However, we have developed a proprietary process to formulate them that is aimed at avoiding the reduced antitumor activity and increased risk of side effects associated with making camptothecins water-soluble.

Potential Additional Karenitecin Development Areas

In addition to potential for treatment of ovarian cancer, we believe Karenitecin has development potential for other oncology indications including advanced non-small cell lung cancer, metastatic melanoma, small cell lung cancer, colorectal cancer, lymphomas, leukemias and breast cancer.