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Kosan Presents Promising Phase 1 Data on Second-Generation Hsp90,Inhibitor, Alvespimycin, Showing Antitumor Activity in Refractory,Breast and Ovarian Cancers at ASCO

the 3 patients with ovarian cancer, -- 1 patient (13 prior regimens) who was on study for more than 16 months had a near complete resolution of ascites and left pleural effusion, and an 83% decrease in CA125.

Toxicities were mainly Grade 1 and 2 (diarrhea, fatigue, headache, arthralgia, nausea). One patient with multiple prior trastuzumab and doxorubicin containing regimens experienced a dose-limiting toxicity of hypoxia and left ventricular ejection fraction reduction at 100 mg/m2. Two patients treated at 80 mg/m2 experienced reversible Grade 3 ocular keratitis; following a treatment holiday both patients continued therapy with reduced doses (one patient remains on study).

Data from a separate 13-patient ongoing Phase 1 trial of alvespimycin also administered weekly were presented. These data showed a confirmed partial response in one patient with hormone refractory prostate cancer, who remains on study after 12 months, and prolonged stable disease in 2 patients, including one patient with prostate adenocarcinoma (on study for 22 weeks) and one patient with metastatic melanoma (on study for 15 weeks). There was no dose-limiting or Grade 3 or 4 drug-related toxicity associated with weekly doses of alvespimycin at up to 40 mg/m2. These data were presented by investigators from the United Kingdom on Sunday, June 3, 2007, in a poster titled "A Phase I Trial of the Heat Shock Protein 90 (Hsp90) Inhibitor 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin (17-DMAG, Alvespimycin) Administered Weekly)."

Alvespimycin Development Plan

Kosan's Phase 1 trial of alvespimycin in combination with trastuzumab is continuing, with plans to add paclitaxel (Taxol(R)) to the regimen.

Kosan plans to initiate a Phase 2 study of alvespimycin as monotherapy in patients with HER2-positive metastatic breast cancer who have not previously been treated with trastuzumab. This trial will be conducted in Eastern Europe. Kosan anticipat
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