BioNumerik Pharmaceuticals and ASKA Pharmaceutical Co. Announce Results from Phase III Clinical Trial of Ta...(rapy regime of paclitaxel and cisplatin ...),Health

Date:3/17/2008

rapy regime of paclitaxel and cisplatin was combined with Tavocept or placebo to evaluate Tavocept's potential for reducing troublesome peripheral neuropathy. There was an approximately 50% decrease in severe sporadic or cumulative neuropathy, not statistically significant, probably due to the study's size. Other side effects such as kidney damage and chemotherapy-induced vomiting were also less in Tavocept treated patients. Unexpectedly, there also was a longer median survival for patients receiving Tavocept, especially for patients with the adenocarcinoma subtype, the most common type of lung cancer in the United States. The findings of increased efficacy combined with decreased toxicity are very encouraging, but these results will require verification in other studies."

Previous Phase III clinical trials for Tavocept measured neuropathy only in terms of cumulative neuropathy and they were inconclusive. BioNumerik and ASKA believe the results from this trial demonstrate that chemotherapy-induced neuropathy is both sporadic and cumulative; a hypothesis that this trial tested prospectively in a multicenter, double-blind, placebo controlled setting.

BioNumerik has granted KI Pharmaceuticals, Inc. the exclusive right to develop, market, distribute and sell Tavocept in Japan. BioNumerik holds exclusive rights to Tavocept for territories outside of Japan.

About Adenocarcinoma:

Adenocarcinoma is a type of cancer that can occur in cells that are in organs such as the lung, colon, prostate and breast. Adenocarcinoma is the most common type of lung cancer, making up approximately 30%-50% of all cases.

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. BioNumerik currently has two drug candidates, Karenitecin(R) and Tavocept(TM), in late-stage clinical development. BioNume
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SOURCE BioNumerik Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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