BioCentury
ARTICLE | Clinical News

PRI-724: Phase I/II started

September 24, 2012 7:00 AM UTC

Prism began an open-label, U.S. Phase I/II trial evaluating IV PRI-724 in about 140 patients with advanced myelogenous malignancies. The trial comprises a Phase Ia portion to determine the maximum tolerated dose (MTD) of PRI-724, a Phase Ib expansion portion to further define the safety of the MTD and a Phase II portion to evaluate escalating doses of PRI-724 in combination with dasatinib in CML patients or low-dose cytarabine in AML patients >=65 years of age. PRI-724 is also in a Phase I trial to treat solid tumors.

In April 2011, Prism granted Eisai exclusive rights to the product to treat solid tumors and leukemia. Eisai also has an option to an exclusive license to develop and commercialize PRI-724 derivatives for the indications. Prism is eligible to receive over $300 million, including upfront and milestone payments, plus tiered royalties. ...