Geron Initiates Clinical Trial Of GRN163L In Combination With Bortezomib And Dexamethasone In Patients With Multiple Myeloma
Geron Corporation (Nasdaq:GERN) today announced that it has enrolled the first multiple myeloma patient in a clinical trial of its telomerase inhibitor drug, GRN163L, in combination with other treatments.
The primary objective of the Phase I dose escalation study is to determine the safety, maximum tolerated dose (MTD) and objective response rate of GRN163L when administered intravenously in combination with bortezomib (Velcade®) with and without dexamethasone in patients with relapsed or refractory disease.
“There is a need for novel therapies in the treatment of multiple myeloma,” said William Bensinger, M.D. of the Fred Hutchinson Cancer Research Center, a principal investigator for the trial. “GRN163L has shown synergistic effects in combination with bortezomib in preclinical models of multiple myeloma, so we are very interested in assessing this treatment regimen in patients.”
This is the second trial to be conducted of GRN163L in multiple myeloma. A Phase I single agent study initiated is ongoing.
“We are pleased to reach this milestone in the clinical development of our lead anti-cancer drug,” said Fabio Benedetti, M.D., Geron’s chief medical officer, oncology. “We have been able to draw on our experience to date with GRN163L from our ongoing single agent studies, including in multiple myeloma, for critical aspects of the design of this combination trial. Our clinical program for this drug now includes six active trials evaluating GRN163L as either a single agent or in combination with current treatment regimens.”
Preclinical studies have also demonstrated that GRN163L can inhibit clonogenic growth of both primary myeloma patient samples and subpopulations from myeloma cell lines enriched for cancer stem cells. These subpopulations show resistance to several conventional agents, including bortezomib. Cancer stem cells capable of clonogenic growth may play an important role in rapid regrowth of tumors after initial reduction by standard treatments.
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