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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

us (grade 3 and 4) treatment related adverse events. A substantial reduction in chemotherapy-induced renal (kidney) toxicity and nausea/vomiting was also observed in the Tavocept group.

"The observations from the U.S. Tavocept Trial are extremely encouraging," said Frederick H. Hausheer, M.D., chairman & chief executive officer of BioNumerik. "The increase in patient survival with Tavocept compares favorably to observations seen for other cancer drugs. For example, the cancer drug Avastin(R) (also known as bevacizumab) was approved in the United States to treat lung cancer while exhibiting a survival increase of approximately two months when used with a standard chemotherapy treatment regimen. Recent data for the cancer drug Erbitux(R) (also known as cetuximab) demonstrated a survival increase of about 1.2 months compared to chemotherapy alone in patients with advanced epidermal growth-factor receptor (EGFR)- detectable non-small-cell lung cancer."

Earlier this year, BioNumerik and ASKA Pharmaceutical Co., Ltd. ("ASKA") reported results from a randomized, multi-center Phase III clinical trial of Tavocept that also indicated a survival increase in adenocarcinoma and non- small cell lung cancer patients. That clinical trial (the "Japan Tavocept Trial") was conducted in Japan by ASKA and involved 182 advanced non-small cell lung cancer patients who received the chemotherapy drugs paclitaxel and cisplatin every three weeks. Half of the patients in the trial received Tavocept along with their chemotherapy, while the other half received a placebo and chemotherapy. The results from the Japan Tavocept Trial demonstrated an observed increase in median survival time of approximately 138 days (4.5 months) for adenocarcinoma patients receiving Tavocept as compared to those receiving placebo. For all non-small cell lung cancer patients participating in the Japan Tavocept Trial, the median survival time observed for patients receiving Tavocept was approximately 40 d
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SOURCE BioNumerik Pharmaceuticals, Inc.
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