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Hana Biosciences Announces Positive Interim Results From a Phase I Trial of Talotrexin (PT-523) in Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 14, 2005--Hana Biosciences (AMEX:HBX), a South San Francisco-based biopharmaceutical company focused on advancing cancer care, announced today positive interim data from an ongoing, multi-center Phase I clinical study evaluating single agent Talotrexin (PT-523) in relapsed or refractory advanced non-small cell lung cancer (NSCLC). The Talotrexin in Lung Cancer (TLC-1) study will be presented at the American Association for Cancer Research-National Cancer Institute-European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC) International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia, Pennsylvania, on November 16, 2005.

The multi-center, multinational study is an open-label, dose finding study that seeks to determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT) 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 (EGFR) tyrosine kinase inhibitor.

Study Results

Talotrexin was administered as a 5 minute intravenous infusion (IV) on Days 1, 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. Tumor response and disease progression relative to baseline was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) methodology. Toxicity was graded using the National Cancer Institute Common Toxicity Criteria (NCI-CTC).

At this interim analysis, 15 patients have received a total of 50 cycles of Talotrexin (median 3, range 1-8) at doses of 27 mg/m2 to 270 mg/m2 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. These interim results suggest:

-- Talotrexin was well tolerated over multiple cycles of therapy, with mucositis, febrile neutropenia, and thrombocytopenia being the most commonly reported adverse events. The MTD remains to be determined in the ongoing study.

-- Clinical benefit in 10 (2 partial responses + 8 stable disease) of 15 treated patients was observed in 67% of patients after 2 or more cycles of Talotrexin in doses below the MTD. One patient who previously failed pemetrexed (Alimta®) has received 8 cycles of talotrexin therapy. Median duration of PR and SD has not been reached.

-- Phase II studies in NSCLC are warranted and will commence immediately upon the completion of the current safety and dose finding study.

"We are encouraged about the activity of Talotrexin in this group of heavily pre-treated non-small cell lung cancer patients," commented Greg Berk, MD, Chief Medical Officer and Vice President of Hana Biosciences. "This novel antifolate builds on a well established mechanism of DHFR inhibition, and this preliminary clinical data confirm what has been observed in preclinical models," noted Dr. Berk.

Jennifer Garst, MD, Assistant Professor of Medicine at Duke University, and an investigator on the trial commented, "Antifolates clearly have a role in the management of advanced non-small cell lung cancer. These preliminary data are encouraging and support taking this drug into the phase II setting."

About Talotrexin

Talotrexin is a novel nonpolyglutamatable antifolate drug which has demonstrated improved antitumor activity in a broad spectrum of cancer models by targeting dihydrofolate reductase (DHFR) to prevent DNA synthesis and inhibit tumor growth. Compared to methotrexate in preclinical studies, Talotrexin enters into cells up to 10-times more efficiently, demonstrated 10- to 100-fold more potency by overcoming resistance by remaining active in tumors by not requiring polyglutamation, and binds more tightly to its anti-tumor target DHFR which enhances efficacy.

Two additional early phase dose finding clinical trials are underway: Phase I trial at the Dana Farber Cancer Institute (DFCI) in patients with solid tumors; and a Phase I/II multi-center trial in relapsed or refractory acute lymphocytic leukemia. Additional phase II trials in cervical, endometrial, ovarian cancers are forthcoming.

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