Geron Corporation has announced that it enrolled its first patient in a clinical trial of GRN163L in multiple myeloma. The trial is the fourth underway involving Geron’s novel inhibitor of telomerase, an enzyme that is expressed in all major types of cancer cells.
The primary objective of the Phase I/II study is to determine the safety and maximum tolerated dose (MTD) of GRN163L when administered intravenously in patients with multiple myeloma who have failed at least two courses of standard chemotherapy.
In addition, researchers will perform correlative laboratory studies on primary patient samples to characterize the effects of GRN163L on myeloma cancer cells.
“We’re pleased to have participated in the design of this study,” said Asher Chanan-Kahn, M.D., an attending physician with Roswell Park Cancer Institute’s Department of Medicine and the lead investigator of the trial.
“Despite recent advances in the treatment of patients with multiple myeloma, the need for curative therapy still exists. GRN163L is intriguing because of its novel mechanism of action and demonstrated preclinical activity as a single agent in animal models. This trial should help us to understand the role that telomerase inhibition could play in multiple myeloma treatment regimens,” Asher added.
Alan Colowick, M.D., Geron’s president, oncology, said, “This study is a critical step in the development of GRN163L. It will enable us to further characterize the drug’s safety profile while investigating the impact of GRN163L on multiple myeloma. Positive findings from this study could lead to a pathway for the use of GRN163L as a single agent for patients with this disease. Furthermore, we plan to initiate combination studies next year for which we will call on our early dosing experience from the current study.”