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BioNumerik & Grelan present data on novel chemoprotecting agent

Orlando, FL, May 21, 2002 BioNumerik Pharmaceuticals, Inc. and Grelan Pharmaceutical Co., Ltd. today announced the presentation of results from a phase 1 clinical study of the novel investigational drug BNP7787 at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Orlando this week.

BNP7787 has so far demonstrated an impressive safety profile, commented Hashime Kanazawa, Ph.D., Executive Vice President and Chief Operating Officer of Grelan. Although this study was not designed to demonstrate tumor response we are encouraged by observations of an apparently high tumor response rate.

The data presented is derived from a Japanese Phase 1 clinical trial of BNP7787 in patients with advanced non-small cell lung cancer receiving paclitaxel and cisplatin. The trial was designed to evaluate the safety and pharmacokinetics of BNP7787 in order to establish a clinically recommended dose and to assess the effects of BNP7787 on paclitaxel and cisplatin combination therapy. No severe nerve damage (Grade 3 or Grade 4) was observed in any of the patients treated in the trial. In addition, of the twenty-one patients receiving chemotherapy, nine experienced a partial tumor remission (greater than or equal to a 50% reduction in tumor size) after two cycles of treatment with BNP7787 with paclitaxel and cisplatin. Eight additional patients experienced no progression (stable disease) while on therapy.

The neurotoxic effects of chemotherapies such as taxanes and platinum based drugs can seriously limit their effective use for the treatment of cancer, said Frederick H. Hausheer, M.D., Chairman and Chief Executive Officer of BioNumerik. These are promising results for BNP7787. We look forward to working with Grelan to initiate pivotal trials in Japan later this year.

BNP7787 is a novel chemoprotecting agent aimed at preventing common and serious side effects associated with taxane and platinum drugs, which are widely u
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Contact: Ruey-Li Hwang
r.hwang@nrp-euro.com
415-677-4455 x209
Noonan/Russo Communications
22-May-2002


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