Confirming safety and feasibility of vaccination with DCP-001in the open label, non-randomized trial, the study demonstrated a positive, vaccination induced immune response in addition to prolonged survival in several patients.
DCPrime CEO Marcel Zwaal said, "Given the stage of disease of these patients, the results of our study are compelling, and provide us with a solid basis to advance our lead product DCP-001 to a multicenter Phase II study in a larger patient population and continue the development of this promising treatment for AML."
A total of 12 patients at high risk of relapse, and who are not entitled for standard post-remission therapy were enrolled in the dose escalation study, which involved administering four vaccinations with a gap of two weeks.
Product related adverse events were not noted during the study, expect for local injection site reactions.
VUmc principal investigator and hematology professor Prof. Dr. Arjan van de Loosdrecht said dendritic cell vaccines such as DCP-001 might become the potential therapeutic alternative to AML patients in the near future.
"We look forward to working with the Company to further develop DCP-001 in a multicenter randomized Phase II trial," Dr. Arjan van de Loosdrecht added.