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Kosan Presents Preliminary Phase 2 Data Showing Antitumor Activity,of Hsp90 Inhibitor Tanespimycin in Metastatic Melanoma at ASCO

stration trials and has the potential to be the first Hsp90 inhibitor to reach the market. Our TIME registration program for tanespimycin in patients with multiple myeloma is on track to be initiated in the third quarter of 2007, which will be a major milestone for our company."

Phase 2 Tanespimycin Melanoma Trial

Tanespimycin binds to and inhibits the activity of Hsp90. Hsp90 inhibition results in the degradation of a variety of RAF family proteins, including mutant BRAF. As the majority of melanomas have activation of the BRAF-MAP kinase pathway, it is postulated that tanespimycin interrupts the MAP kinase pathway and may lead to clinically significant anti-melanoma effects. The Phase 2 trial of tanespimycin was designed as a multi-center two-stage Simon design study; continuation to the second stage required at least 1 of the first 9 patients to have a progression-free survival (PFS) time of at least 24 weeks, the primary endpoint of the trial. Eligible patients had stage M1 melanoma, measurable/unresectable disease and had progressed within 3 months of study entry with no more than 1 prior chemotherapy treatment for metastatic melanoma. Tanespimycin was administered at a dose of 275 mg/m2 by 1-2 hour intravenous infusion 2 times per week every 2 out of 3 weeks until disease progression or toxicity. 20 patients have been enrolled, and efficacy data are available on 14 evaluable patients. One of the 6 evaluable patients with a BRAF mutation (V600E) showed evidence of anti-melanoma activity. An additional patient with BRAF mutation continues on study but is too early to assess for efficacy at present. The safety profile has been manageable and included predominantly Grade 1 and 2 toxicities (constitutional and gastrointestinal symptoms). Grade 3 or 4 toxicity, which was generally manageable and reversible, resulted in treatment discontinuation in 2 patients. Accrual is continuing toward the goal of enrolling a total of 30 evaluable patients (with cont
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