TIME-1 is designed as a Phase 3 trial in patients with disease relapse following a single prior course of treatment (first-relapse). TIME-1 is planned to be a randomized, open-label, multi-center international trial with a primary endpoint of progression free survival (PFS), comparing two groups: patients treated with bortezomib plus tanespimycin (dosed at 340 mg/m2) and patients treated with bortezomib alone. The primary endpoint is designed to be progression-free survival.
Kosan Biosciences is a biotechnology company advancing two new classes of anticancer agents through clinical development -- Hsp90 (heat shock protein 90) inhibitors and epothilones. Kosan is leveraging its proprietary discovery platform to generate a pipeline of potentially significant product candidates, primarily in the area of oncology.
Hsp90 inhibitors have a novel mechanism of action targeting multiple pathways involved in cancer cell growth and survival. Tanespimycin (KOS-953) is being tested in combination with bortezomib (Velcade(R)) in patients with multiple myeloma in a registration program called TIME. Tanespimycin is also being studied in HER2-positive metastatic breast cancer in combination with trastuzumab (Herceptin(R)), and as monotherapy in metastatic melanoma. Intravenous and oral formulations of Kosan's second-generation Hsp90 inhibitor, alvespimycin (KOS-1022), are being evaluated in Phase 1 clinical trials in hematologic and solid tumors and in HER2-positive metastatic breast cancer.
Epothilones inhibit cell division through a mechanism of action similar
to taxanes, one of the most successful classes of anti-tumor agents.
|SOURCE Kosan Biosciences Incorporated|
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