KIYATEC, Inc. announced the enrollment of the first patients in a U.S. clinical study of its Ex Vivo 3D drug response assay (EV3D™) across several difficult-to-treat solid tumors. The 3D-PREDICT clinical study has been initiated at the Cancer Institute of Greenville Health System (GHS) with the goal of recruiting 640 patients across additional clinical sites to be added in the future.
The 3D-PREDICT Study is a prospective, open-label, multi-institutional, non-interventional study to validate the EV3D assay for clinical use and to investigate the impact on outcomes for cancer patients with both newly diagnosed and recurrent epithelial ovarian cancer and recurrent high-grade gliomas, which include glioblastomas (GBM).
Over the next year or so, the study will expand to include patients with newly diagnosed high-grade gliomas, high-grade rare tumors, and triple negative breast cancer.
The primary objectives of the study are to establish the correlation between assay predicted drug response and patient clinical outcomes and to measure the potential impact of the assay on therapeutic decision-making. The study is anticipated to continue through 2022.
3D culture microenvironment
The EV3D assay platform assesses a patient's own cancer cells within a biologically relevant 3D culture microenvironment to provide individualized response prediction to specific therapeutic agents. In this study, the therapeutic agents predicted to consist of available, guideline-recommended drug options for each cancer type.
"As an institution, we've supported KIYATEC's pilot clinical studies by providing over 450 samples of cancer tissues spanning the multiple tumor types they are testing and our clinical investigators are ready to take this important next step," said Larry Gluck, MD, Medical Director of the GHS Cancer Institute.
"Patients with recurrent ovarian cancer and recurrent GBM are among those with the most challenging prognosis at every cancer center around the country. The fact that KIYATEC is offering us a new tool in these very difficult to treat populations is a needle mover for these patients coming to Greenville for their treatment."
"Patients with these kinds of newly diagnosed and recurrent cancers simply do not have the luxury of time on their side. Their time, health and money spent on a treatment that is not working can have devastating consequences that we all want to avoid," said Matthew Gevaert, CEO of KIYATEC.
"The commencement of this clinical trial builds upon the success of our pilot studies and represents a significant milestone toward our goal of helping cancer patients receive the best treatment at the earliest possible time."