Geron Initiates Clinical Trial of GRN163L in Combination with Paclitaxel and Bevacizumab in Patients with Breast Cancer
News Aug 21, 2008
The primary objective of the Phase I/II, dose escalation study is to determine the safety, maximum tolerated dose (MTD) and objective response rate of GRN163L when administered intravenously in combination with a paclitaxel/bevacizumab regimen in this patient population.
"We are excited to have enrolled the first patient in this study," said Kathy D. Miller, M.D., Associate Director for Clinical Research at the Indiana University Melvin and Bren Simon Cancer Center and lead investigator of the trial. "We have anticipated the clinical evaluation of this drug in breast cancer based on promising preclinical studies."
"This is an important milestone in the clinical development of our lead anti-cancer drug," said Fabio Benedetti, M.D., Geron's chief medical officer, oncology. "Extending the clinical testing of GRN163L to breast cancer reflects the potentially broad and important role of telomerase in fighting cancer."
The current study is the fifth clinical trial of GRN163L. Studies are ongoing at 14 other U.S. medical centers in patients with chronic lymphoproliferative diseases, multiple myeloma, non-small cell lung cancer, and other solid tumor malignancies administering GRN163L as either a single agent or in combination with conventional treatments. More information about these trials can be found in the Patient Information section of Geron's website at www.geron.com or on the NIH clinical trials registry at www.clinicaltrials.gov (search "GRN163L").