FOR IMMEDIATE RELEASE:

Contact:
BioNumerik Pharmaceuticals, Inc.
Public Relations Department
(210) 614-1701, ext. 500
email: publicrelations@bnpi.com

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

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

- Median survival increase of 6.5 months seen for patients with adenocarcinoma, the most
common type of lung cancer

San Antonio, TX, July 17, 2008 -- 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™ 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^®) 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^® (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^® (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^® and Tavocept™, 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.

***

FOR IMMEDIATE RELEASE:

Contact:
BioNumerik Pharmaceuticals, Inc.
Public Relations Department
(210) 614-1701, ext. 500
email: publicrelations@bnpi.com

BioNumerik Pharmaceuticals and ASKA Pharmaceutical Co. Announce Results from Phase III Clinical Trial of Tavocept™

- Data provides evidence of survival increase in advanced non-small cell lung cancer
patients receiving Tavocept in conjunction with paclitaxel and cisplatin

- Multiple statistically significant findings include reductions in chemotherapy-induced
kidney damage and vomiting

San Antonio, TX and Tokyo, Japan, March 18, 2008 -- BioNumerik Pharmaceuticals, Inc. (“BioNumerik”) and ASKA Pharmaceutical Co., Ltd. (“ASKA”) today announced the results of a Phase III clinical trial of Tavocept™ 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 cellproduction.

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 ASKA 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^® and Tavocept™, 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.

***

Contacts:
           
                                BioNumerik Pharmaceuticals, Inc.
                                Tel: 210.614.1701

 

BioNumerik Commences Global Phase III Ovarian Cancer Trial
on Novel Anticancer Drug Candidate Known as Karenitecin^®

 

February 7, 2008 --- BioNumerik Pharmaceuticals, Inc. today announced treatment of the first patient in a global Phase III clinical trial of BioNumerik's anticancer drug candidate known as Karenitecin^® in advanced ovarian cancer patients. BioNumerik is developing Karenitecin (also known as BNP1350) as an investigational new anti-tumor drug in the camptothecin class of chemotherapy drugs. Based on prior studies, BioNumerik believes Karenitecin has the potential for fewer side-effects, better efficacy, and less susceptibility to drug resistance mechanisms compared to the currently marketed camptothecin drugs.

The Phase III trial has been designed as a global, randomized, multi-center open label trial to prospectively evaluate the safety and efficacy of Karenitecin compared to the chemotherapy drug topotecan (also known as Hycamtin^®). Either Karenitecin or topotecan will be given intravenously daily for 5 consecutive days repeated every 3 weeks to advanced ovarian cancer patients who have previously been treated with platinum and taxane chemotherapy drugs but have become resistant to the platinum/taxane therapy. BioNumerik has received written agreement from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) regarding the clinical trial design and protocol.

Four Phase II clinical trials of intravenously administered Karenitecin have been completed in the U.S. in patients with advanced ovarian cancer, metastatic malignant melanoma, advanced non-small cell lung cancer, and primary brain tumors. BioNumerik has also initiated a Phase I clinical trial to evaluate the safety and effectiveness of an orally administered Karenitecin formulation. Based on prior studies, BioNumerik believes Karenitecin may have the following potential advantages over currently marketed camptothecins:

* Comparable or improved effectiveness in the treatment of certain cancers, with a potentially improved safety profile and fewer of the dose-limiting side-effects caused by camptothecin drugs including:

- lower incidence of severe diarrhea than that caused by irinotecan (also known as Camptosar^®);

- lower incidence of anemia and neutropenia (reduction in white blood cell counts), than that caused by topotecan (also known as Hycamtin^®);

* Less susceptibility than currently marketed camptothecins to common drug resistance mechanisms found in many types of human cancer cells, including resistance mechanisms that are specific to the camptothecin class; and

* Because Karenitecin is lipophilic (fat loving), BioNumerik believes Karenitecin may have enhanced tissue penetration, drug delivery and bioavailability compared to existing water soluble camptothecins.

In commenting on these developments, Frederick H. Hausheer, M.D., BioNumerik's Chairman & Chief Executive Officer stated: "There is a large unmet need for 2nd and 3rd -line therapies that can prevent progression of recurrent or progressive ovarian cancer with reduced risk of cumulative toxicity in patients who have become resistant to platinum/taxane-based chemotherapy. Ovarian cancer is difficult to diagnose early and patients are usually diagnosed with advanced disease (Stage III or IV). Outcomes for patients with advanced ovarian cancer remain poor. Up to 80% of ovarian cancer patients who initially respond to treatment will ultimately relapse and require additional therapy, and treatment options for patients with advanced recurrent ovarian cancer are limited. In addition, all approved agents for the treatment of advanced ovarian cancer are associated with significant toxicity that can be dose-limiting."

Dr. Hausheer added, "We believe the safety and efficacy outcomes from the previously completed Karenitecin Phase II advanced ovarian cancer trial compare favorably with the historically reported results of approved agents. Based on the Phase II outcomes and our pre-clinical data, we are pursuing Karenitecin Phase III testing in advanced ovarian cancer patients who have become resistant to platinum/taxane chemotherapy."

# # #

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. The Company currently has two drug candidates, Karenitecin^® and Tavocept™, 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.