Protein Design Says Zamyl Failed Tests
ORLANDO, Fla. -- Protein Design Labs (PDLI Quote) said Sunday that its experimental leukemia drug, Zamyl, doesn't work well enough to pass muster with U.S. drug regulators -- another setback for the troubled biotech company.
The Fremont, Calif.-based company said 36% of patients suffering from advanced acute myeloid leukemia responded to Zamyl when given in combination with chemotherapy. But 28% of patients given just chemotherapy also responded -- a statistically insignificant difference. The disappointing data was released Sunday at the annual meeting of the American Society of Clinical Oncology.
"Based on this analysis, we do not plan to seek meetings with regulatory authorities or to consider filing a Biologic License Application for Zamyl at this time," said PDL's acting CEO Doug Ebersole, in a statement. Ebersole took over the company's reins after former CEO Larry Korn resigned unexpectedly May 1. ...
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