US-based clinical stage biopharmaceutical firm Cellceutix has initiated its main clinical site at a Texas-based cancer centre to begin the Phase IIa clinical trial (CTIX-KEV-201) of Kevetrin for the treatment of platinum-resistant / refractory ovarian cancer.
Kevetrin is a small molecule developed to trigger the activation of a protein p53 for controlling cell mutations.
The open-label Phase IIa trial will evaluate the safety, tolerability, pharmacokinetics, changes in select biomarkers and objective tumour response of the intravenously administered drug.
The trial is comprised of two different short-term treatment regimens and will enrol a total of ten patients.
The Phase IIa trial aims to determine Kevetrin’s multimodal mechanism of action and will utilise molecular mapping technology to analyse ovarian cancer tissue samples taken from the study's subjects.
The ovarian cancer tumour cells are reported to metastasise either directly via the organs of the pelvis region, through the bloodstream or lymphatic system.
The primary objective is to measure the incidence of treatment-emergent adverse events (TEAEs) and changes in pre-specified biomarkers through tumour biopsy, examination of ascites fluid and peripheral blood, as well as pre-treatment and post-treatment at three weeks.
The trial will also establish the secondary outcome measures such as objective tumour response, per response evaluation criteria in solid tumours (RECIST) and plasma concentrations of Kevetrin.
A Phase I clinical trial of Kevetrin in the treatment of advanced solid tumours has reported good toleration and positive signs of potential therapeutic response in the subjects.
Kevetrin has secured orphan drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, in addition to rare pediatric disease designation for childhood retinoblastoma from the US Food and Drug Administration (FDA).