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,
|SOURCE Kosan Biosciences Incorporated|
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