Clinical Studies

In 2005, the Geron Corporation submitted an investigational new drug application to begin a phase I/II dose-escalation trial of GRN163L in patients with CLL. Another phase I trial in patients with solid tumors began in 2006. Both trials are dose-escalation studies designed primarily to evaluate the safety, tolerability, and pharmacokinetics of intravenous GRN163L infusion. Subjects in the CLL trial were infused with GRN163L over six hours, and subjects in the solid tumor trial were infused over two hours. Though as yet unpublished, data from these trials were presented at the 18th EORTC-NCI-AACR International Conference. No serious adverse events or dose-limiting toxicity has been observed in any of the first three cohorts of the solid tumor trial or the first two cohorts of the CLL trial. Patients in the first cohort of the CLL trial were administered 0.5 mg/kg GRN163L and had an average peak plasma concentration of 1.44 |g/ml. Drug levels were measurable for 8-12 hours after the start of infusion with an initial half-life of around four hours. The doses administered to these cohorts are expected to be subtherapeutic, but the results support further dose escalation (Tressler et al. 2006).

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