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www.fdanews.com/articles/62670-hana-updates-progress-of-cancer-trials-with-talvesta

HANA UPDATES PROGRESS OF CANCER TRIALS WITH TALVESTA

September 20, 2006

Hana Biosciences has provided an update on the company's Talvesta (talotrexin) for Injection clinical trial program. Hana is conducting multiple clinical trials with Talvesta in order to evaluate the most appropriate dose and schedule of administration, and Talvesta's activity in multiple cancers.

Talvesta is currently in three separate trials in hematological and solid tumors, including a Phase I/II trial in acute lymphoblastic leukemia, a Phase I/II trial in non-small-cell lung cancer (NSCLC) and a Phase I trial in solid tumors. In the fourth quarter of this year, Hana will also be initiating a Phase I/II trial in solid tumors and advanced gastric cancer using a 21-day dosing schedule to enhance the therapeutic index of the drug.

Hana last year commenced an open-label, multicenter Phase I/II clinical trial of Talvesta in the treatment of refractory leukemias. The primary objectives of the Phase I portion of the study are to evaluate the safety of Talvesta when administered on days one through five on a 21-day cycle to establish the maximum-tolerated dose and to identify dose-limiting toxicities. The company expects to complete the Phase I portion and launch the Phase II portion before the end of 2006.

The company is also currently conducting a Phase II clinical trial in NSCLC. Based on information received to date, Hana believes there is potential to improve the therapeutic index through an adjustment in the dosing schedule. As a result, Hana plans to evaluate the safety and tolerability of Talvesta administered once every three weeks in a Phase I/II solid tumor trial scheduled to commence in the fourth quarter of 2006. Once dosing and safety on this new schedule are evaluated, the company plans to use this schedule in Phase II trials in both NSCLC and advanced gastric cancer.