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BioNumerik Pharmaceuticals Observes Evidence of a Survival Increase in Lung Cancer Patients Participating in Tavocept(TM) Clinical Trial
Date:7/17/2008

ays longer than the median survival time for patients receiving placebo.

Dr. Hausheer added: "The results from the U.S. Tavocept Trial are important because they confirm and expand on the results from the Japan Tavocept Trial, and represent the second time we have seen this type of a survival increase. The increased survival observed in both the U.S. and Japan Tavocept trials appears to involve the novel pharmacological mechanisms of Tavocept, which appear to be insensitive to ethnicity or region. In addition, both trials showed a reduction in chemotherapy-induced toxicities in the Tavocept group with no dose limiting toxicity observed for Tavocept in either trial. These observations support that Tavocept has the potential to prevent common and serious side effects due to chemotherapy without any substantial dose-limiting toxicity of its own. Based on these results, we are planning to pursue confirmatory Phase III development of Tavocept in the United States and Japan."

The U.S. Tavocept Trial observations occurred in a patient population that was predominantly non-Asian, compared to the Japan Tavocept Trial where the patient population was entirely Asian. This indicates that the potential survival increase observed for adenocarcinoma patients receiving Tavocept appears to occur across different ethnic groups. Since the U.S. Tavocept Trial involved cisplatin and the taxane drug docetaxel while the Japan Tavocept Trial involved cisplatin and the taxane drug paclitaxel, BioNumerik has also now observed this pattern of a Tavocept increase in survival in first-line non-small cell lung cancer treatment regimens utilizing two different types of taxane chemotherapy drugs.

"It is also important to consider that the U.S. Tavocept Trial was a Phase II clinical trial involving a relatively small number of patients and that the observations regarding survival and toxicity reduction related to secondary analyses and endpoints for the trial," added Dr. Haushe
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SOURCE BioNumerik Pharmaceuticals, Inc.
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