BioCentury
ARTICLE | Clinical News

Elacytarabine: Development discontinued

April 8, 2013 7:00 AM UTC

Clavis discontinued development of elacytarabine after the open-label, international Phase III CLAVELA trial in 380 patients with relapsed or refractory AML showed that 2,000 mg/m 2/day elacytarabine given as a continuous IV infusion on days 1-5 of a 3-week cycle missed the primary endpoint of improving median OS vs. investigator's choice of therapy (3.5 vs. 3.3 months, HR=0.97). Adverse events were comparable between treatment arms. Clavis said it will evaluate next steps for the company over the next few weeks, with the most likely possibilities being a sale to a public company, a reverse merger with a private company or a managed closure. Elacytarabine has Fast Track and Orphan Drug designations in the U.S., and Orphan Drug designation in the EU to treat AML. ...