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news.Geron, a biopharmaceutical company, has announced positive interim data from its ongoing Phase I clinical trial of GRN163L, a telomerase inhibitor drug, in patients with relapsed and refractory multiple myeloma.
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This study of GRN163L as a single agent is one of six ongoing clinical trials recruiting from 18 US medical centers examining the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug, alone or in combination, in solid tumors, chronic lymphoproliferative disease, multiple myeloma, lung and breast cancers.
Data were reported on 13 patients, each of whom received at least one infusion of GRN163L with a range of one to 19 doses, from 3.2mg/kg to 7.2mg/kg. Patients had received up to eight prior systemic treatment regimens for multiple myeloma, with a median of four prior regimens, including four patients who had received autologous bone marrow transplantation.
Pharmacodynamic results were reported from two patients who had samples of pre-and post-treatment bone marrow collected. Both bulk and tumor stem cell-containing fractions were assessed for telomerase inhibition. Both patients received multiple infusions of GRN163L at 4.8mg/kg and had achieved relatively high plasma levels of the drug.
According to the company, telomerase activity in the bulk tumor fraction of bone marrow from those two patients decreased by 78% and 48%, respectively, after GRN163L treatment. Telomerase activity in the myeloma stem cell-containing fraction of their bone marrow declined by 33% and 63% respectively.
GRN163L was generally well tolerated. The maximum tolerated dose for continuous weekly dosing of GRN163L was below 7.2mg/kg. Clinical responses have not been seen in this heavily pre-treated, refractory population to date, and patients continue to accrue at a dosing level of 6mg/kg, the company said.
Thomas Okarma, president and CEO of Geron, said: These preliminary results suggest that pharmacodynamic effects in myeloma patients’ tumor-containing bone marrow are evident at a GRN163L dose of 4.8mg/kg, a well tolerated dose in these patients. These data are the first evidence in man of telomerase inhibition by a telomerase targeting drug and will help us optimize dosing schedules to enable sustained telomerase inhibition that hopefully will translate into clinical activity.