Geron (GERN) Presents Interim Data from Imetelstat at AACR-NCI-EORTC Int. Conference

November 19, 2009 8:30 AM EST

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.

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.

Exposure to imetelstat during the treatment period was determined by measuring the concentrations of the drug in the plasma of patients prior to and following infusions and calculating the Area Under the Curve (AUC) for drug concentration against time. At doses of 7.5 mg/kg and above, the level of exposure to imetelstat was higher than the exposure that is associated with inhibition of telomerase and tumor growth in multiple xenograft animal models. Preliminary analysis of pre- and post-treatment hair follicle samples for pharmacodynamic activity shows a trend for telomerase inhibition.

Related Categories

Corporate News

Stocks Mentioned

Add Your Comment

Name

Subject

Body

Verification can't see the text?
click here to refresh the image.
what's this?