resolution of lung metastases by CT/PET with significant improvement in
dypsnea (shortness of breath);
-- 1 patient (11 prior regimens, 5 with trastuzumab, 2 with lapatinib)
showed 10% reduction in tumor mass with change consistent with tumor
necrosis and a decrease in 2 tumor markers (64% CEA, 63% CA27.29);
-- 1 patient (5 prior regimens) showed a partial response after 2 cycles,
confirmed after 4 cycles, with 52% decrease hepatic lesions);
-- 5 patients had extended stable disease (4, 6+, 6+, 8 and 10 months).
Of the 3 patients with ovarian cancer,
-- 1 patient (13 prior regimens) who was on study for more than 19 months
with evaluable disease had a near complete resolution of ascites and
left pleural effusion at the end of cycle 2, and an 83%
decrease in CA125.
Toxicities were mainly Grade 1 and 2 (diarrhea, fatigue, headache, arthralgia, nausea). One patient with multiple prior trastuzumab and doxorubicin containing regimens experienced a dose-limiting toxicity of shortness of breath and left ventricular ejection fraction reduction at 100 mg/m2. Two patients treated at 80 mg/m2 experienced reversible Grade 3 ocular keratitis; following a treatment holiday both patients continued therapy with reduced doses (one patient remains on study). Kosan plans to continue to enroll patients at the 80 mg/m2 for further safety and efficacy evaluation.
Expanded Phase 1 Trial Includes Paclitaxel
Kosan has expanded the Phase 1 trial to add weekly dosing with paclitaxel (Taxol (R)). In this triplet combination regimen, patients will continue to receive trastuzumab at full dose on a continuous weekly schedule. Alvespimycin will be dosed weekly for 3 weeks out of 4, and paclitaxel will be given on the same schedule.
Alvespimycin Development Plan
In the fourth quarter of 2007, Kosan plans to initiate a Phase 2 trial
of alvespimycin as monotherapy
|SOURCE Kosan Biosciences Incorporated|
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