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Kosan Initiates Phase 2 Trial of Alvespimycin, Second-Generation Hsp90 Inhibitor, in HER2-Positive Metastatic Breast Cancer
Date:1/15/2008

nts in a two-stage trial design. Patients with HER2-positive metastatic disease and no prior trastuzumab treatment except as adjuvant therapy (with the last dose more than 12 months prior to study entry) are eligible to participate in the trial. Alvespimycin will be administered intravenously on a one-hour weekly infusion schedule of 80 mg/m2 for three weeks out of four weeks in repeated cycles.

Kosan is also testing alvespimycin delivered orally in a Phase 1 dose escalation trial exploring different schedules.

Promising Antitumor Activity Shown in Phase 1

In September, at the 2007 ASCO Breast Cancer Symposium, Kosan reported that alvespimycin demonstrated promising antitumor activity and tolerability in combination with trastuzumab in a Phase 1 trial of patients with refractory HER2-positive metastatic breast cancer, and in patients with refractory ovarian cancer who were progressing on standard chemotherapy. Of the 27 heavily-pretreated patients enrolled in the Phase 1 trial, 24 patients had HER2-positive metastatic breast cancer and 3 patients had ovarian cancer (HER2 status unknown). Clinical benefit was observed in 42% of patients (8 of 19 evaluable) with HER2-positive metastatic breast cancer. Of 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 in this Phase 1 trial were mainly Grade 1 and 2 (diarrhea, fatigue, headache, arthralgia, nausea) with 80 mg/m2 established as the recommended Phase 2 dose for weekly intravenous administration. Kosan is currently enrolling a Phase 1 trial to investigate alvespimycin plus trastuzumab and paclitaxel to establish the initial safety profile and pharmacokinetics of this triplet regimen and to lay the groundwork for a potential larger Phase 2/3 trial.

About Kosan

Kosan Biosciences is a biotechnology company advancing two new
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SOURCE Kosan Biosciences Incorporated
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