Hana Biosciences, a biopharmaceutical company focused on advancing cancer care, initiated a multi-centre, multinational Phase II clinical trial with Talotrexin (PT-523) in relapsed or refractory non-small cell lung cancer (NSCLC).

The primary objective of this Phase II portion of an ongoing Phase I/II open-label study is to demonstrate an improvement in overall survival. Secondary objectives are evaluation of safety, overall response rate, time to progression, and progression free survival. Relapsed or refractory NSCLC patients who have failed at least two lines of treatment including standard chemotherapy and/or an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor are eligible to enrol in the study. Patients who meet all eligibility criteria will receive Talotrexin on a 21-day cycle.

Myelosuppresion and mucositis were the dose limiting toxicities of the
Phase I portion of the trial that determined the recommended Phase II dose of Talotrexin in this setting. Updated clinical trial data will be presented during the 42nd Annual American Society of Clinical Oncology (ASCO) meeting in Atlanta, June 2-6, 2006.

"Advancing into Phase II is an exciting step forward in the development of Talotrexin as a potential therapy for heavily pre-treated non-small cell lung cancer patients," noted Greg Berk, Chief Medical Officer and Senior Vice President, Hana Biosciences.

Jennifer Garst, 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."

Talotrexin is a novel nonpolyglutamatable antifolate drug which has demonstrated improved anti-tumour activity in a broad spectrum of preclinical cancer models by targeting dihydrofolate reductase (DHFR) to prevent DNA synthesis and inhibit tumour growth.