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news.Geron's telomerase inhibitor cancer drug has demonstrated good pharmacokinetics and tolerability in its ongoing phase I/II trial involving patients with chronic lymphocytic leukemia, according to the biopharmaceutical company.
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A pharmacokinetic analysis of three patients in the highest dose cohort of 160mg/m2 has shown transient peak plasma concentrations of approximately 10ug/ml. This and other data indicate that the drug, GRN163L, continues to exhibit favorable pharmacokinetic properties that are linear with respect to the doses tested so far, Geron said.
Up to the current dose levels, no significant changes in telomerase activity or telomere length in the bulk circulating chronic lymphocytic leukemia (CLL) cells of treated patients have been observed. These pharmacodynamic results are consistent with expectations because of the relatively short exposure of CLL cells in patients’ blood to concentrations of drug capable of inhibiting telomerase.
With dosing and accrual to cohort 4 continuing, patients treated at the current dose levels have tolerated the drug well, and the maximum tolerated dose has not yet been identified. “We are encouraged by the results,” said Dr Alan Colowick, the company’s president.
“Based on preclinical data demonstrating the effects of GRN163L on both mature and cancer stem cells in multiple myeloma, Geron will initiate a clinical trial involving multiple myeloma patients. In addition, the company will begin a fourth trial of GRN163L in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer. The basis for this trial is the result of promising preclinical animal data demonstrating the drug’s activity in this tumor type as well. Geron expects to initiate both trials in the coming months.”