Geron Corporation (Nasdaq:GERN) today announced the presentation of
interim data from its phase II trial of GRNVAC1, an autologous dendritic
cell vaccine targeting telomerase, in patients with acute myelogenous
leukemia (AML) at the 51st Annual Meeting of the American
Society of Hematology (ASH) in New Orleans, Louisiana.
The multicenter, open-label trial is designed to evaluate the
feasibility of GRNVAC1 manufacture and the safety and tolerability of
the vaccination regimen in patients with AML who are in complete
clinical remission. Additional objectives of the study are to evaluate
the immune responses to GRNVAC1 and to explore the effects of
vaccination on minimal residual disease and relapse rates in this
patient population.
“First, we are pleased to have met our endpoints of safety and
tolerability,” said Stephen M. Kelsey, M.D., Geron's executive vice
president and chief medical officer, oncology. “At this point in the
study a number of high risk patients have entered the extended boost
phase of the vaccination regimen. These patients have been in remission
for a period ranging from four months to nearly two years. Our analyses
of minimal residual disease by qPCR of WT-1 are also very encouraging
with one patient whose WT-1 levels became undetectable following
vaccination.”
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