Zamyl: Phase III

PDLI said that in a U.S. study of 191 patients with AML, the combination of its Zamyl humanized antibody with chemotherapy did not show a significant difference compared to chemotherapy alone on the primary endpoint of complete response rate within 70 days of starting treatment. The Zamyl group had an overall response rate of 43% compared to 26% for chemotherapy alone (p=0.015). The trial enrolled patients who had failed to achieve complete remission with initial therapy, or who had relapsed within 1 year of achieving complete remission. PDLI said that higher response rates were observed in patients with longer initial complete remissions. PDLI expects to submit a BLA for Zamyl in 2003. ...