04 Mar 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Boehringer Ingelheim has initiated phase III study (POLO-AML-2) investigating volasertib, a selective and potent polo-like kinase (Plk) inhibitor, in combination with chemotherapy, in patients with acute myeloid leukaemia (AML) ineligible for intensive therapy.
Acute leukaemias are rare diseases, with AML being the most deadly acute leukaemia in adults. Professor Klaus Dugi, corporate senior vice president medicine, Boehringer Ingelheim, said that, "Rare diseases are often incorrectly diagnosed and even once they are correctly diagnosed, there is often a lack of viable treatment options."
AML is characterized by the rapid proliferation of abnormal blood precursor cells that accumulate in the bone marrow and interfere with the production of normal blood cells. The primary endpoint of POLO-AML-2 is objective response to the combination treatment compared to the chemotherapy alone. The main secondary endpoint of POLO-AML-2 is overall survival.
The study was initiated following positive results from a phase II study which demonstrated higher rates of objective response and an improvement in event free survival in patients receiving volasertib in combination with chemotherapy versus chemotherapy alone.
"Boehringer Ingelheim is committed to developing innovative medications that improve patients' lives and has put considerable effort into research and development of treatments for orphan diseases," said Professor Dugi.