Hana Biosciences to start phase 2 trial of Talotrexin for lung cancer

By Elaine Rigoli

Tampa, Fla., March 31 - Hana Biosciences Inc. said Friday it will begin its multi-center, multi-national phase 2 clinical trial with Talotrexin (PT-523) in patients with relapsed or refractory non-small cell lung cancer.

The primary objective of this phase 2 portion of an ongoing phase 1/2 open-label study is to demonstrate an improvement in overall survival, according to a news release.

Secondary objectives are evaluation of safety, overall response rate, time to progression and progression-free survival.

Relapsed or refractory non-small cell lung cancer patients who have failed at least two lines of treatment including standard chemotherapy and/or an epidermal growth factor receptor tyrosine kinase inhibitor are eligible to enroll in the study, the company said.

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 1 portion of the trial that determined the recommended phase 2 dose of Talotrexin in this setting, according to the release.

Hana Biosciences is a South San Francisco, Calif.-based biopharmaceutical company that acquires, develops and commercializes products to advance cancer care.

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