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Hana Biosciences Initiates Talotrexin Phase II Clinical Trials in ...

... 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 enroll 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 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 These preliminary data are encouraging and support taking this drug into the phase II setting." Summ...