HANA BIOSCIENCES ANNOUNCES DATA FROM TRIAL OF TALOTREXIN
Hana Biosciences has reported positive interim data from an ongoing, multicenter
Phase I clinical study evaluating single agent Talotrexin (PT-523) in relapsed
or refractory advanced non-small cell lung cancer (NSCLC).
The multicenter, multinational study is an open-label, dose finding study that
seeks to determine the maximum tolerated dose, dose-limiting toxicities, and
obtain preliminary objective tumor response in NSCLC patients who failed at
least two lines of standard chemotherapy and/or an epidermal growth factor receptor
tyrosine kinase inhibitor.
Talotrexin was administered as a five minute intravenous infusion (IV) on Days
1 and 8 of a 21-day cycle with folic acid and B12 vitamin supplementation. Eligible
patients with ECOG performance status of 0-2 were administered increasing doses
of Talotrexin. At this interim analysis, 15 patients have received a total of
50 cycles of Talotrexin at doses of 27 mg to 270 mg per cycle. Thirteen patients
had evaluable CT scans, and all evaluated have failed previous platinum therapy.
Talotrexin administered on this schedule as a single agent has demonstrated
acceptable tolerability with encouraging activity in patients with relapsed
or refractory NSCLC.