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Kosan's Hsp90 Inhibitor, Tanespimycin, Shows 55% Clinical Benefit in Patients With Trastuzumab-Refractory Metastatic Breast Cancer

owing administration of the standard dose of trastuzumab.

Of 26 patients enrolled in the trial, 20 were evaluable for efficacy (3 patients were not evaluable for efficacy and 3 patients are too early to assess). Of the 26 patients enrolled, 21 were treated with Kosan's prior Cremophor(R)-containing injection formulation of tanespimycin (4 of whom were crossed over to receive the recently introduced Injectable Suspension formulation), and 5 were treated with the Injectable Suspension formulation (3 of whom were recently enrolled and are not yet evaluable). Of the 20 patients evaluable for efficacy, 11 responded, yielding a clinical benefit rate of 55%.

-- 5 patients experienced confirmed partial responses, including,

-- 1 patient with 75% decrease in liver metastases with 42% drop in

CEA; 8 months on study;

-- 1 patient with 45% decrease in a hilar node, continuing on study

after 14 months;

-- 1 patient with 33% decrease in right breast lesions with decreased

tumor markers, continuing on study after 7 months;

-- 1 patient with 57% decrease in lymph nodes, liver and left breast

lesions, continuing on study after 7 months; and

-- 1 patient with 37% decrease in lymph nodes, continuing on study

after 5 months.

-- 2 patients experienced minor responses with decreased tumor markers (on

study for 6 and 5 months).

-- 4 patients had stable disease for 4, 4, 7, and 8 months.

Common toxicities were mainly Grade 1 and 2 and included diarrhea, fatigue, dizziness and headache. Treatment-related Grade 3 toxicities were experienced by 3 patients and included reversible fatigue and headache, increased liver function tests that resolved in 9 days and unsteady gait and euphoric mood that resolved in a single day. Noticeably absent were toxicities associated with conventional chemotherapy, including alopecia, mye

SOURCE Kosan Biosciences Incorporated
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