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Kosan's Second-Generation Hsp90 Inhibitor, Alvespimycin, Shows 42% Clinical Benefit in Phase 1 HER2-Positive Metastatic Breast Cancer Trial
Date:9/10/2007

ety profile of this triplet regimen and to lay the groundwork for a potential larger Phase 2/3 trial. We expect to start our Phase 2 monotherapy trial in newly-diagnosed HER2-positive patients later this year. We believe that the clinical activity of alvespimycin seen in our breast cancer Phase 1 trials to date validates the compound's therapeutic potential as a novel anticancer agent and strengthens Kosan's leadership in the Hsp90 inhibitor area."

Phase 1 Updated Results

Alvespimycin is a second-generation Hsp90 inhibitor that has demonstrated the potential to disrupt the activity of multiple oncogenes and cell signaling pathways implicated in tumor growth, including HER2, a key signaling pathway in breast cancer.

Preliminary results from the Phase 1 trial of alvespimycin in combination with trastuzumab were presented at the 2007 ASCO annual meeting in June, and were updated in this presentation. The Phase 1 trial was designed to identify the recommended Phase 2 dose through the evaluation of toxicity and activity in patients with solid tumors. Patients were enrolled in three dose cohorts. The dosing schedule for alvespimycin was a one-hour weekly intravenous infusion of 60, 80 or 100 mg/m2 administered along with the standard dose of trastuzumab. Patients were assessed every 4 weeks for toxicity and every 8 weeks for response. Disease response was assessed by RECIST and by tumor markers, if available.

Of the 27 heavily-pretreated patients enrolled in the trial, 24 patients had HER2-positive breast cancer (with the majority of patients having had multiple trastuzumab-containing regimens prior to this study) and 3 patients had ovarian cancer (HER2 status unknown).

Clinical benefit was observed in 42% of evaluable patients (8 of 19 evaluable) with HER2-positive metastatic breast cancer:

-- 1 patient (13 prior regimens, including progression on single-agent

lapatinib and 3 prior trastuzumab-containing regimens) showed compl
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SOURCE Kosan Biosciences Incorporated
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