The primary objective of the Phase I/II study is to determine the safety and maximum tolerated dose 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.
Alan Colowick, Geron’s president for 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.”