The BET inhibitor, OTX015, is a synthetic orally administered drug targeting BET bromodomain proteins 2/3/4 responsible for transcription of growth-promoting and cell cycle regulators.
Initially the trial will perform dose escalation studies in two parallel subsets of patients with acute leukemia and other hematologic malignancies to determine the optimum dosing regimen for OTX015.
The study will then evaluate safety, pharmacokinetics, pharmacodynamics and clinical activity in disease specific cohorts of at least 12 patients treated at the recommended dose.
OncoEthix CEO Bertrand Damour said, "We believe that OTX015 has the potential to be an important new drug in the continuing battle to improve and extend the lives of patients with cancer."
During the company’s preclinical studies, the OTX015 induced potent anti-proliferative effects associated with cell cycle arrest, cellular senescence or apoptosis while treating acute leukemia (both cell lines and patients’ cells), various subtypes of lymphoma and multiple myeloma cell lines, according to the company.
Oncoethix said OTX015 was in-licensed from Mitsubishi Tanabe Pharma in March 2012, following completion of Phase I clinical studies in healthy volunteers.