(RTTNews) - Biopharmaceutical company Geron Corp. (GERN:
News ), Thursday presented interim data from its ongoing trial of imetelstat, a telomerase inhibitor drug at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.
The analysis of the ongoing Phase I study was presented by Geron clinical scientists and collaborating principal investigators from the University of Chicago Medical Center and Barbara Ann Karmanos Cancer Center.
Menlo Park, California based company said that the study was conducted on 25 patients with advanced solid tumor malignancies, dosage started at 4.8 mg/kg and escalation proceeded to 11.7 mg/kg. 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.
The interim data about the study stated that 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.
Exposure to imetelstat during the treatment period was determined by measuring the concentrations of the drug in the plasma of patients before and after infusions and calculating the Area Under the Curve for drug concentration against time.
The Phase I study of the drug as a single agent is one of six company-sponsored 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.
Stephen Kelsey, executive vice president and chief medical officer, oncology said, "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."
GERN is currently trading at $5.72, down $0.19 or 3.21% on the Nasdaq.
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by RTT Staff Writer
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