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BioNumerik Pharmaceuticals, Inc. and ASKA Pharmaceutical Announce Results from Phase III Clinical Trial of Tavocept(TM)  
3/18/2008 7:26:03 AM

SAN ANTONIO and TOKYO, March 18 /PRNewswire/ -- BioNumerik Pharmaceuticals, Inc. ("BioNumerik") and ASKA Pharmaceutical Co., Ltd. ("ASKA") today announced the results of a Phase III clinical trial of Tavocept(TM) in patients with advanced non-small cell lung cancer. Tavocept is an investigational new drug with potential for oncology and non-oncology indications that was originated and developed by BioNumerik.

The multicenter, double-blind, randomized, placebo controlled Phase III clinical trial was conducted by ASKA in Japan through the joint venture, KI Pharmaceuticals, Inc., with BioNumerik. The trial included 182 patients with advanced non-small cell lung cancer who received the chemotherapy drugs paclitaxel and cisplatin as first-line therapy every three weeks. Half of all patients in the trial received Tavocept along with their chemotherapy, while the other half received a placebo and chemotherapy. The primary trial endpoint was to evaluate Tavocept's potential for preventing and reducing the severity of sporadic and cumulative nerve damage, or neuropathy, experienced by patients receiving paclitaxel and cisplatin chemotherapy.

The trial results indicate that the number of patients reporting either severe sporadic or cumulative neuropathy was approximately 50% lower in the Tavocept arm of the trial compared to the placebo arm. While this outcome represents a strong trend in favor of Tavocept (p = 0.1565), the results are not statistically significant (p < 0.05). BioNumerik and ASKA believe the lack of statistical significance is likely due to the relatively small size of the trial.

A surprising and medically important observation from the trial was an observed increase in the median survival time for patients receiving Tavocept as compared to those receiving placebo. The median survival time observed for patients receiving Tavocept was approximately 40 days longer than for patients receiving placebo. For patients with adenocarcinoma, the most frequently occurring type of lung cancer, the median survival time was increased by approximately 138 days for patients receiving Tavocept as compared to those receiving placebo.

Frederick H. Hausheer, M.D., Chairman & Chief Executive Officer of BioNumerik, and Chairman of KI Pharmaceuticals, Inc. stated: "We are encouraged by the observed evidence of Tavocept's potential to protect against sporadic (i.e. intermittent) and cumulative chemotherapy-induced neuropathy. The observed survival benefit in this patient population along with significant reductions in renal toxicity, vomiting and anemia further support our belief in this drug's therapeutic potential. We observed that a substantial proportion of the patients from the trial are still alive and we will continue to monitor the survival of these patients. We believe that this Phase III trial outcome is an important step towards the validation of our approach to cancer drug discovery and development."

Hashime Kanazawa, Ph.D., Executive Director of ASKA, and President of KI Pharmaceuticals, Inc. stated: "We are pleased with this result, particularly the multiple statistically significant findings that were observed. This data will be the basis for further studies, which we intend to pursue expeditiously. We are currently in the process of reviewing a number of additional Tavocept clinical trial designs."

Additional observations from the trial included a statistically significant reduction in cisplatin-induced kidney damage (nephropathy) and a statistically significant reduction in chemotherapy-induced vomiting for patients receiving Tavocept in comparison to those receiving placebo. There were also substantially fewer instances of physician chemotherapy dose reductions, treatment delays or discontinuance of chemotherapy treatment due to neuropathy in the Tavocept arm of the study, compared to the placebo arm. Patient quality of life questionnaire scores were more favorable in the Tavocept arm of the study.

The trial results also included substantial evidence of the potential ability of Tavocept to maintain or stimulate hematological function in the body, as well as the potential to mitigate or prevent chemotherapy-induced anemia and to maintain or stimulate erythropoietin function or synthesis. Erythropoiesis is the process by which red blood cells are produced, and involves the release of a hormone called erythropoietin that stimulates the red bone marrow to begin red blood cell production.

In commenting on the observations from the trial, Ross C. Donehower, M.D., Director of Medical Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Professor of Oncology and Medicine at the Johns Hopkins University School of Medicine; and a member of BioNumerik's Scientific Advisory Board stated: "This is the culmination of years of hard work and commitment on the part of BioNumerik leadership and employees, as well as the investigators and AKSA Pharmaceutical Co. It has the potential to improve cancer therapy and decrease toxicity in a meaningful way. It is a very exciting result."

Michael C. Perry, M.D., M.A.C.P., Professor of Hematology and Medical Oncology, Nellie B. Smith Chair Emeritus, Ellis Fischel Cancer Center, University of Missouri-Columbia; and a member of BioNumerik's Scientific Advisory Board, stated: "Multi-center randomized, double-blind, placebo- controlled phase III trials such as this one are usually regarded as the 'gold standard' for proving the efficacy of drugs in oncology. In this study of patients with advanced non-small cell lung cancer, the standard chemotherapy 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. BioNumerik has eight additional drug discovery research programs, and has generated a patent portfolio of more than 450 patents and pending patent applications worldwide.

About ASKA:

ASKA, located in Tokyo, Japan, is a research and development (R&D) oriented company, which contributes to the society by developing and providing innovative pharmaceutical products with concentrating its management resources to the specific therapeutic areas. Additional information about ASKA is available through its corporate website, www.aska-pharma.co.jp/english/index.html. ASKA and BioNumerik have formed KI Pharmaceuticals, Inc., located in Tokyo, Japan, as a joint venture aimed at developing a broad portfolio of new compounds to distribute and market in Japan.

publicrelations@bnpi.com

CONTACT: Public Relations Department, BioNumerik Pharmaceuticals, Inc.,
+1-210-614-1701, ext. 500, publicrelations@bnpi.com

Web site: http://www.aska-pharma.co.jp/english/index.html/


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