Geron starts clinical trial for lung cancer drug

The primary objective of the phase I/II study is to determine the safety and maximum tolerated dose of GRN163L when administered intravenously in combination with a standard paclitaxel/carboplatin regimen. This is the first time the drug has been clinically tested in combination with standard chemotherapy.

Alan Colowick, Geron’s president, oncology, said: “The favorable tolerability and pharmacokinetics demonstrated so far in our solid tumor and CLL trials enable us to test our drug in combination with standard chemotherapy in patients for the first time. Once we have established the safety and dosing parameters of GRN163L in combination with paclitaxel and carboplatin in NSCLC, we can study the same combination in other tumor settings.”

Geron’s two ongoing clinical trials are sequential cohort, dose escalation studies designed to determine the safety and tolerability of GRN163L administered intravenously on a weekly basis as monotherapy to patients with refractory or relapsed chronic lymphocytic leukemia, and patients with advanced solid tumors.