Lestaurtinib

Lestaurtinib (rINN, codenamed CEP-701) is a tyrosine kinase inhibitor structurally related to staurosporine.

[5] The most significant effort was invested in developing lestaurtinib for the treatment of acute myelogenous leukemia (AML).

[6] Initial Phase I studies with lestaurtinib involved determination of pharmacokinetic parameters following a single dose in healthy volunteers.

Next, safety and tolerability were investigated in a Phase I trial involving 30 volunteers with advanced solid tumors or lymphoma.

A multi-center Phase II study of 29 patients above the age of 60 was initiated for treatment with lestaurtinib alone; the results, reported in 2006, indicated that the primary endpoint of complete remission was not achieved in any participants.

[12] Lestaurtinib was mentioned as one of two oncology drugs being developed by Cephalon in a 2007 U.S. Securities and Exchange Commission (SEC) report.

[13] In the wake of preliminary failing results for the Phase III clinical trial involving Lestaurtinib, Cephalon founder and CEO Frank Baldino, Ph.D., issued the following statement in 2009: We made a significant financial investment in this pioneering effort to develop lestaurtinib for this molecularly targeted patient population with a poor prognosis and few treatment options.

[11][12] In their 2011 annual SEC report, Teva did not include lestaurtinib in a listing of major oncology drugs in their pipeline.