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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

ity in multiple tumor types, underscoring the therapeutic potential of this important class of anticancer compounds and strengthening Kosan's leadership in the Hsp90 inhibitor area."

Phase 1 Alvespimycin 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.

The Phase 1 trial of alvespimycin in combination with trastuzumab 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.

Of the 25 heavily-pretreated patients enrolled in the trial, 22 patients had HER2-positive breast cancer and 3 patients had ovarian cancer (HER2 status unknown). The median number of prior regimens excluding hormonal therapy was 6.5, and the median prior trastuzumab-containing regimens for the HER2-positive breast cancer patients was 4. Clinical benefit was observed in 35% of patients (7 of 20 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 near

       complete resolution of lung metastases by CT/PET with significant

       improvement in shortness of breath (8 cycles at 60 mg/m2);


    -- 1 patient (11 prior regimens, 5 with trastuzumab, 2 with lapatinib)

       showed 10% reduction in tumor mass (change consistent with tumor

       necrosis) and a decrease in 2 tumor markers (64% CEA, 63% CA27); this

       patient continues on study;


    -- 5 patients had extended stable disease (4, 5, 6+, 11+ and 12 months).


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