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Kosan Presents Updated Data on Hsp90 Inhibitor, Tanespimycin, in Multiple Myeloma at Ash
Date:12/8/2007

ed the injectable suspension formulation and 13 received the Cremophor-containing formulation.

To date, the response rate at the 340 mg/m2 dose is lower than that in the earlier, dose-escalating group that received doses of tanespimycin between 100 and 275 mg/m2.

The combination of tanespimycin and bortezomib was well-tolerated. There was no increase in toxicity with the injectable suspension formulation compared to the Cremophor-containing formulation observed with the tanespimycin plus bortezomib combination dosed at 340 mg/m2 and 1.3 mg/m2, respectively. Common toxicities were similar for the two tanespimycin formulations. Common tanespimycin toxicities (primarily Grade 1-2) were gastrointestinal (diarrhea, nausea, vomiting), fatigue, reversible increased liver function tests (LFT), dizziness, headache, insomnia and musculoskeletal malaise. Grade 3 tanespimycin toxicities were limited to diarrhea, fatigue and increased LFT. No cardiovascular toxicity was observed.

Common toxicities associated with bortezomib included thrombocytopenia (Grade 3-4 at 1.3 mg/m2) and neuropathy (Grade 1-2, at 1.3 mg/m2). A lower than anticipated rate of neuropathy was observed in the tanespimycin plus bortezomib combination, and no patient experienced a Grade 3 neuropathy. In prior bortezomib trials (the SUMMIT and CREST trials), 13% Grade 3 neuropathy was observed. This observation supports the hypothesis that treatment with tanespimycin exerts a neuroprotective effect.

Tanespimycin in Myeloma Evaluation (TIME) Program

The Phase 1b trial is ongoing and multiple patients remain on study. Kosan intends to complete the trial and report the final data at a later date.

Kosan's TIME registration program has been opened, with the initiation of the TIME-2 trial. TIME-2 is a Phase 2/3 trial in patients with relapsed- refractory multiple myeloma. The multi-site, open-label trial is being conducted primarily in the US and Europe. TIME-2 is designed to c
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SOURCE Kosan Biosciences Incorporated
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1. Kosans Motilin Receptor Agonist, Licensed to Pfizer, Enters Phase 1 Clinical Trial in Gastroesophageal Reflux Disease
2. Kosan Opens Registration Program for Lead Hsp90 Inhibitor, Tanespimycin, in Multiple Myeloma
3. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
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