Interim data from Geron's ongoing imetelstat trial presented at the AACR-NCI-EORTC conference

Nov 19 2009

Geron Corporation (Nasdaq:GERN) today announced the presentation of interim data from its ongoing trial of imetelstat (GRN163L), a telomerase inhibitor drug, in patients with refractory, advanced solid cancers at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

This Phase I study of imetelstat as a single agent is one of six company-sponsored Phase I clinical trials designed to examine 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.

“I am pleased to report that we have met our Phase I objectives for imetelstat and can advance the program,” said Stephen M. Kelsey, M.D., F.R.C.P., F.R.C.Path., Geron’s executive vice president and chief medical officer, oncology. “As the data from the study in patients with solid tumors presented today illustrates, we are achieving exposures to imetelstat that exceed the levels that have been associated with efficacy in several models of human cancers and we are also observing telomerase inhibition in tissue samples from patients, while minimizing hematological toxicities through an alternative dosing schedule. In 2010 we plan to initiate four Phase II clinical trials of imetelstat in multiple cancers.”

An interim analysis of the ongoing Phase I study of imetelstat in patients with advanced solid tumor malignancies that do not respond to standard treatments was presented by Geron clinical scientists and collaborating principal investigators from the University of Chicago Medical Center and Barbara Ann Karmanos Cancer Center. Data were presented on 25 patients, with one currently on study. The patients were given imetelstat as a single agent by two hour intravenous infusions using an intermittent dosing schedule on days one and eight of 21-day cycles (two weeks on treatment, one week off). Dosing started at 4.8 mg/kg and escalation proceeded to 11.7 mg/kg. Prior to enrollment, 22 of 25 patients had received a mean of four prior cytotoxic treatment regimens and 15 had received prior irradiation.

Source Geron Corporation