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Kosan Presents Phase 1 Data Showing Promising Antitumor Activity,and Safety Profile of Epothilone KOS-1584 at ASCO

e, later in 2007."

Phase 1 Trial Results of KOS-1584

The Phase 1 trial was designed to define the maximum tolerated dose, dose- limiting toxicity and recommended Phase 2 dose, and to assess early activity of KOS-1584 when administered to patients with advanced solid tumors (no standard curative therapy options). The Phase 1 trial dose schedules initially included a 1-hour weekly infusion for 3 weeks out of 4, and weekly for 2 weeks out of 3. More recently, a dose schedule of a 3-hour infusion was initiated on both weekly schedules (2 out of 3 weeks, 3 out of 4 weeks) to allow reduced Cmax (reduced peak exposure) with similar overall exposure enabling maximization of dose intensity.

A total of 50 patients have been enrolled in the Phase 1 trial. Indications of antitumor activity were observed in 32% of patients evaluable for efficacy, including,

    -- 1 confirmed partial response (PR) in a patient with advanced non-small

       cell lung cancer (3 prior chemotherapy regimens); this patient had 44%

       tumor shrinkage by RECIST, and withdrew after 10 months (10 cycles)

       while still in PR;

    -- 1 patient with advanced ovarian cancer (4 prior regimens) had 40% CA125

       decline and 20% shrinkage of nodal disease;

    -- 1 patient with advanced prostate cancer had 94% reduction in PSA and

       improved nodal disease after cycle 2 and was on study for 6 months

      (6 cycles); and

    -- Patients with stable disease (3 or more months) include those with head

       and neck, prostate, ovarian, breast, non-small cell lung, colon,

       pancreatic and cervical cancers.


Common drug related toxicities on the 1-hour, 3-week and 4-week schedules were similar and were predominantly gastrointestinal symptoms and fatigue.

    -- On the 4-week, 1-hour infusion schedule, dose-limiting toxicity was

       primarily diarrhea observed at 20 and 25 mg/m2; no dose-limiting

       toxicity was observed at
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