Date: 2015-06-18
Type of information: Clinical trial authorization
phase: 1
Announcement: clinical trial authorization
Company: OncoTherapy Science (Japan)
Product: OTS167
Action
mechanism: kinase inhibitor. OTS167 is a targeted compound that has a potent inhibitory activity on MELK (maternal embryonic leucine zeipper kinase), a serine/threonine protein kinase in formation and maintenance of cancer stem cells. Experiments using xenograft mice models have demonstrated that OTS167 shows potent anti-tumor activities against lung, prostate, breast and pancreatic cancers.
Disease: solid tumors metastatic tumors
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The purpose of this study is to test the safety and tolerability of OTS167. In this first-in-human study OTS167 will be administered to patients with solid tumors which have not responded to treatment. (NCT01910545)
Latest
news: * On June 18, 2015, OncoTherapy Science announced that the protocol amendment of Phase I clinical study of OTS167, which aim to evaluate the bioavailability of OTS167 by oral administration, was approved by the FDA and the medical center’s Institutional Review Board at the University of Chicago Medicine, and all procedures to conduct this study have been completed now.
The safety, efficacy and pharmacokinetic profiles of OTS167 given intravenously have been evaluated through the on-going clinical trial. The purpose of current protocol amendment is to facilitate the clinical development of OTS167, because high bioavailability results will make it possible to conduct the clinical trial using not only intravenous but oral administration. The clinical development using both formulations will hold the promise of the shortening development period and the expansion of indications.
