“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 used for treating cancer. Based on existing preclinical and clinical data and the lack of effective therapy for these side effects, the FDA has granted fast track development designation for the use of BNP7787 to prevent or reduce the incidence or severity of paclitaxel-associated nerve damage. A pivotal placebo controlled Phase 3 study in metastatic breast cancer patients is currently underway in the U.S. to evaluate BNP7787 in the prevention or reduction of nerve damage caused by paclitaxel, the most widely used taxane. BioNumerik and its alliance partners plan to initiate additional pivotal trials for BNP7787 in Japan and Europe during 2002.
Grelan Pharmaceutical Co., Ltd., headquartered in Tokyo and one of the Takeda group of companies, was established in 1930 to manufacture analgesics for the Japanese marketplace. Since then, Grelan has also established itself as a specialist in the development and marketing of formulations for cardiovascular, gastrointestinal, and respiratory conditions. In September 2000, Grelan and BioNumerik formed a joint venture, known as KI Pharmaceuticals, L.L.C., to bring new anticancer compounds to the Japanese marketplace.
BioNumerik, headquartered in San Antonio, Texas, employs an integrated computational approach to enable the design, selection and creation of novel pharmaceuticals, principally for the treatment of cancer. It is a product-focused company with three drugs in clinical trials. The Company has a very large on-site dedicated high performance computing facility with two Cray SV-1 systems. BioNumerik has entered into strategic alliances with Grelan for the development of BNP7787 in Japan and with Baxter Oncology, a division of Baxter International, for the development of BNP7787 in the European Union and in major territories outside the U.S., Canada and Japan.
Editor’s Note: This release is also available on the Internet at: www.bionumerik.com.
BioNumerik Contacts:
Steve Riebel
Chief Financial Officer
BioNumerik Pharmaceuticals, Inc.
(210) 614-1701 X 221
email: steve.riebel@bnpi.com
Grelan Contact:
Hashime Kanazawa, Ph.D.
C.O.O. and Executive V.P.
Grelan Pharmaceutical Co., Ltd.
+81-(3)5651-8070
email: kanazawa-h@grelan.co.jp
Ian R. McConnell, Ph.D.
Senior Account Executive
Noonan/Russo Presence Euro RSCG
(415) 677-4455 X233
email: i.mcconnell@nrp-euro.com