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

BioNumerik Initiates Treatment of Patients in Global Phase III Clinical Trial of Tavocept™ to Confirm Substantial Survival Increases Previously Observed in Most Common Type of Lung Cancer

European Journal of Clinical & Medical Oncology Publishes Meta-Analysis of Phase II and Phase III Trials Supporting Tavocept’s Potential to Increase Lung Cancer Survival

San Antonio, TX, January 21, 2010 -- BioNumerik Pharmaceuticals, Inc. (“BioNumerik”) today announced the treatment of the first patients in a global multi-center Phase III clinical trial of Tavocept (BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer. In previous studies, Tavocept demonstrated the potential to substantially increase overall and one year patient survival while concurrently preventing and reducing the incidence and severity of common chemotherapy side-effects as compared to other currently available treatments for advanced lung cancer. Tavocept, originated and developed by BioNumerik, is an investigational new drug with potential for oncology and non-oncology indications.

“In two independent studies of first-line use of Tavocept with chemotherapy, we observed an increase in overall survival of up to 6.7 months in patients with primary adenocarcinoma of the lung, the most common type of lung cancer worldwide,” said Frederick H. Hausheer, M.D., F.A.C.P., founder, chairman & chief executive officer of BioNumerik. “If the results of the current Phase III trial prove to be consistent with prior results, Tavocept treatment could result in the largest historically observed increase in patient survival for a first-line agent for the treatment of primary adenocarcinoma of the lung.”

The Phase III Tavocept trial is an international, randomized, multicenter, double-blind, placebo-controlled trial to be conducted at approximately 80 to 100 clinical sites in the United States, Russia, Ukraine, Eastern Europe and Latin America. The primary objective is to confirm whether Tavocept plus taxane and cisplatin chemotherapy significantly increases overall survival in patients with advanced primary adenocarcinoma of the lung compared to taxane and cisplatin treatment alone. Tavocept’s ability to prevent or mitigate common chemotherapy-induced toxicities will be prospectively evaluated by pre-specified secondary endpoint analyses. BioNumerik estimates that patient enrollment for the trial could be completed in late 2010 to early 2011.

Two smaller randomized, multicenter trials of Tavocept, in combination with taxane and cisplatin chemotherapy, previously demonstrated large increases in overall survival and one year survival, compared to the control regimens, in patients with newly diagnosed (inoperable) stage IIIB/IV primary adenocarcinoma of the lung. These increases include a 6.7 month increase in overall survival (8.9 months in control vs. 15.6 months in Tavocept treated patients), with 60% of Tavocept treated patients vs. 36% of control treated patients alive at one year after randomization in a U.S. Phase II clinical trial, and a 4.6 month increase in overall survival (15 months in placebo vs. 19.6 months in Tavocept treated patients), with 73% of Tavocept treated patients vs. 54% of placebo treated patients alive at one year after randomization in a Japanese Phase III trial. These improved survival outcomes were accompanied by medically and statistically significant reductions in favor of Tavocept treatment in the incidence and severity of side effects commonly observed with the chemotherapy control regimens, including reductions in kidney toxicity, anemia, nausea and vomiting, and treatment discontinuation due to chemotherapy-induced neuropathy.

Meta-analysis supports survival improvements in patients with advanced non-small cell lung cancer (NSCLC):
The results of a comprehensive meta-analysis of these two previous randomized Tavocept trials were published this week by the European Journal of Clinical & Medical Oncology (EJCMO). [link to abstract] The meta-analysis examined survival outcomes for a combined total of 346 newly diagnosed randomized patients with advanced NSCLC participating in the two trials, including 211 randomized patients with primary adenocarcinoma of the lung. All patients received treatment with taxane plus cisplatin chemotherapy. Approximately half of the patients were treated with Tavocept while the other half received chemotherapy alone. The analysis demonstrated a significant overall survival benefit in favor of Tavocept treatment for the combined meta-analysis of the two trials. For the adenocarcinoma subtype, the combined analysis demonstrated a significantly (P=0.009) improved overall survival benefit in favor of Tavocept treatment, representing an approximate 7.7 month increase in overall survival, with 68% of Tavocept treated patients alive at one year after randomization vs. 48% of control patients alive at one year after randomization (p=0.003). A meta-analysis uses statistical methods to combine results from previous separate but similar studies in order to evaluate the medical outcomes both independently and in a combined manner.

“The results of the meta-analysis are encouraging and have important medical implications for the first-line treatment of primary adenocarcinoma of the lung,” stated Robert Pirker, M.D., Medical University of Vienna, Austria, and a member of the EJCMO Editorial Board. “Confirmation of these important results in a well controlled Phase III trial would represent a major advance in the treatment of patients with advanced lung cancer.”

Nicholas Thatcher, Professor in Medical Oncology at the University of Manchester and The Christie, England and EJCMO Editorial Board member said, “The potential to improve therapy in primary adenocarcinoma, the most common form of lung cancer, is an exciting possibility. The results of the meta-analysis provide important support for a large scale confirmatory study of Tavocept on patient survival and the prevention of common chemotherapy side effects.”

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, co-author on the meta-analysis publication and a member of BioNumerik’s Scientific Advisory Board said, “Despite some recent improvements, the 5-year overall survival rate for lung cancer is still only 15%. In addition, all currently approved survival-enhancing treatments for lung cancer are associated with common and serious toxicities that adversely impact the patient’s quality of life, and in severe cases, can be fatal. The potential increase in survival represented by Tavocept would be a meaningful advance for patients, particularly if Tavocept is also able to prevent or reduce common and serious chemotherapy-induced side effects.”

Dr. Hausheer added, “If we observe results in the ongoing Tavocept Phase III trial that are consistent with results observed for the Tavocept trials discussed in the meta-analysis publication, this would be a substantial potential advance compared to other recently developed first line lung 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. The cancer drug Alimta^®, also known as pemetrexed, when combined with cisplatin treatment in the first line setting, improved overall survival in primary adenocarcinoma patients by about 1.7 months. Recent data for the cancer drug Erbitux^®, also known as cetuximab, with chemotherapy 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. It is also important to consider that we have previously observed evidence of an overall survival treatment effect by Tavocept in both non-Asian and Asian populations; this is an important observation in consideration of the improved spectrum of activity of EGFR inhibitors in Asian patients and the potentially negative effect of some EGFR inhibitors on overall survival reported in Asian patients. By conducting this confirmatory Phase III Tavocept trial, we hope to improve survival in primary adenocarcinoma patients by a significantly greater margin than currently available treatments and at the same time prevent and mitigate chemotherapy induced anemia, kidney toxicity, nausea and vomiting, and peripheral nerve damage.”

There are currently an estimated total of approximately 106 active Phase III oncology development programs worldwide throughout the entire life science industry. BioNumerik is conducting two global Phase III development programs, consisting of the Tavocept Phase III trial announced today and another Phase III development program for BioNumerik’s novel drug candidate Karenitecin^®, which is currently undergoing testing in a Phase III clinical trial in patients with advanced ovarian cancer. The Karenitecin Phase III trial is being conducted at approximately 86 clinical sites worldwide and is targeted to complete its enrollment by the end of 2010. BioNumerik holds exclusive rights to Tavocept and Karenitecin for all territories outside of Japan. BioNumerik has granted KI Pharmaceuticals, Inc., a joint venture formed by BioNumerik and ASKA Pharmaceutical Co., Ltd., the exclusive right to develop, market, distribute and sell Tavocept and Karenitecin in Japan.

About Tavocept™:
As part of its development efforts, BioNumerik has identified important new mechanisms believed to be associated with survival increases in non-small cell lung cancer patients. BioNumerik has elucidated that Tavocept targets the thioredoxin and glutaredoxin systems, both of which are overexpressed in adenocarcinoma of the lung. It is postulated that Tavocept administration results in interference with key components of the thioredoxin and glutaredoxin systems, which are believed to be major mechanisms involved in the increased survival observed in lung cancer patients receiving Tavocept with chemotherapy.

About Adenocarcinoma and Lung Cancer:
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, comprising about 40% to 65% of all non-Asians and 60% to 85% of all Asians diagnosed with lung cancer. The incidence of adenocarcinoma of the lung appears to be increasing. According to American Cancer Society 2009 estimates, lung cancer is the leading cause (28%) of all cancer deaths in women and men, and kills more people annually than cancers of the breast, prostate, colon, liver, kidney and melanoma, combined. Inoperable adenocarcinoma of the lung is estimated to cause approximately 63,000 to 103,000 deaths in the U.S. annually, and represents approximately 11% to 18% of all estimated U.S. cancer deaths in men and women in 2009.

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, Tavocept™ and Karenitecin^®, in Phase III clinical development. BioNumerik has eight additional drug discovery research programs, and has generated a patent portfolio of more than 475 patents and pending patent applications worldwide.

About the European Journal of Clinical & Medical Oncology:
The European Journal of Clinical & Medical Oncology (EJCMO) is a quarterly, peer–reviewed journal primarily for oncologists, hematologists, interns, radiologists, surgeons, radiation oncologists, palliative care physicians and other specialists interested in cancer diagnosis, management and research. Visit www.slm-oncology.com for additional information.

***

FOR IMMEDIATE RELEASE:

Contact:
BioNumerik Pharmaceuticals, Inc.
Public Relations Department
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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.

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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.