Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multip... (suming that the sponsor follows the prot...)

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Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma

Date:9/6/2007

suming that the sponsor follows the protocol agreed-upon with the Agency, the sponsor has provided appropriate information to the Agency to support the protocol, the sponsor and the Agency agree to modify the protocol or a substantial scientific issue is identified after clinical testing has begun. In the absence of these developments, "completion of a SPA with FDA provides binding agreement relative to design and analysis of key Phase 3 trial(s) such that positive final results can lead to full NDA/ BLA approval." For more information about the Agency's Special Protocol Assessment process, see, http://www.fda.gov/cder/guidance/3764fnl.htm.

About Tanespimycin

Tanespimycin has been shown to induce apoptosis of drug-sensitive and drug-resistant multiple myeloma cell lines. Tanespimycin also inhibits expression of various cell surface cytokines, such as IGF-1R and IL-6R, that are involved in growth, survival and drug resistance of multiple myeloma cells. When used in combination with bortezomib, the destabilization of client proteins with tanespimycin while blocking their degradation with bortezomib promotes the accumulation of cytotoxic proteins, leading to cell death.

Kosan reported data from a Phase 1b trial of tanespimycin in combination with bortezomib at the 2007 annual meeting of the American Society for Clinical Oncology (ASCO) on 56 patients enrolled in 7 dose cohorts (100-340 mg/m2 of tanespimycin; 0.7-1.3 mg/m2 of bortezomib; tanespimycin administered via 1-hour infusion following the bortezomib dose 2 times per week every 2 weeks out of 3 weeks). Of these 56 patients, all had received multiple prior chemotherapy regimens (median of 4) and 67% had received bone marrow transplants.

In those patients who received tanespimycin across the range of doses tested and a dose of 1.0 or 1.3 mg/m2 of bortezomib, the overall response rate including complete, partial and mini
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