Geron Announces FDA Clearance to Start Clinical Trials of Its Telomerase Inhibitor Drug
Geron Corporation announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) to initiate clinical testing of its lead anti-cancer compound, GRN163L, in patients with chronic lymphocytic leukemia (CLL). The company filed its first Investigational New Drug Application (IND) for GRN163L in April 2005.
The initial Phase I/II, open-label, dose-escalation trial of GRN163L will be conducted in patients with advanced CLL. The study is designed to demonstrate the safety and tolerability of GRN163L administered on a weekly intravenous dosing schedule. Pharmacokinetic and pharmacodynamic parameters will also be studied. Importantly, CLL provides a unique opportunity to measure both the magnitude and time course of telomerase inhibition in tumor cells. By serially assessing the effects on the target enzyme in CLL cells, Geron will attempt to define both a dose and a dosing interval that effectively inhibits telomerase activity. This will provide useful data for designing further clinical studies of GRN163L, including combination studies with other approved cancer therapies.
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