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BioNumerik Pharmaceuticals Observes Evidence of a Survival Increase in Lung Cancer Patients Participating in Tavocept(TM) Clinical Trial

- Second instance where survival increase is observed in advanced non-small cell lung cancer patients receiving Tavocept in conjunction with standard


- Median survival increase of 6.5 months seen for patients with

adenocarcinoma, the most common type of lung cancer

SAN ANTONIO, July 17 /PRNewswire/ -- BioNumerik Pharmaceuticals, Inc. ("BioNumerik") today announced that patients with adenocarcinoma (the most frequently occurring form of lung cancer) participating in a Phase II clinical trial of Tavocept(TM) showed a survival increase of approximately 198 days (6.5 months). The trial observations included an approximate 40% reduction in mortality for adenocarcinoma patients receiving Tavocept. The percentage of adenocarcinoma patients in the Tavocept group who were alive after 12 months (One-year survival) was 58% compared to 37% for adenocarcinoma patients in the chemotherapy only group. The median survival time for all non-small cell lung cancer (NSCLC) patients in the trial showed an increase of approximately one month for patients receiving Tavocept. This is the second Tavocept clinical trial where this pattern of survival increase has been observed. Tavocept is an investigational new drug with potential for oncology and non-oncology indications that was originated and developed by BioNumerik.

The randomized Phase II clinical trial (the "U.S. Tavocept Trial") was performed at multiple sites in the U.S. and involved 151 patients with advanced NSCLC who received the chemotherapy drugs docetaxel (sold under the brand name Taxotere(R)) and cisplatin every two weeks. Approximately half of the patients received Tavocept along with chemotherapy, while the other half received chemotherapy alone.

Additional observations from the U.S. Tavocept Trial included a lower level of treatment discontinuation due to adverse events for the Tavocept group as well as a lower frequency of serious (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 days 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. Hausheer. "In addition, the survival analysis in adenocarcinoma patients was not prespecified. The findings are quite encouraging, but these results will require verification in further Phase III clinical studies."

BioNumerik holds exclusive rights to Tavocept for all territories outside of Japan. BioNumerik has granted KI Pharmaceuticals, Inc., a joint venture formed by BioNumerik and ASKA, the exclusive right to develop, market, distribute and sell Tavocept in 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% to more than 50% of all cases. The incidence of adenocarcinoma of the lung appears to be increasing.

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 for cancer supportive care. BioNumerik currently has two drug candidates, Karenitecin(R) and Tavocept(TM), in late-stage clinical development. BioNumerik has eight additional drug discovery research programs, and has generated a patent portfolio of more than 450 patents and pending patent applications worldwide.


BioNumerik Pharmaceuticals, Inc.

Public Relations Department

(210) 614-1701, ext. 500


SOURCE BioNumerik Pharmaceuticals, Inc.
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