3D-PREDICT Study to investigate potential impact to outcomes for several difficult-to-treat solid tumors
GREENVILLE, SC. – June 20, 2018 – KIYATEC, Inc. today 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 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. Details on the trial can be found on ClinicalTrials.gov.
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 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.”
About KIYATEC, Inc.
KIYATEC is changing the future of cancer care by accurately predicting patient-specific response and non-response to chemotherapy drugs before treatment begins. Wasted time is the enemy of cancer patients and there is currently no way to accurately predict which cancer patients will respond to standard oncology treatments. KIYATEC has developed a validated process to use a cancer patient’s own live cells to accurately predict treatment response prior to beginning treatment.
About Greenville Health System
Greenville-based Greenville Health System (GHS) has partnered with Columbia-based Palmetto Health to form a not-for-profit health care delivery system serving 1.2 million patients annually across South Carolina. The new name and graphic identity are expected to be announced later this year. GHS offers patients an innovative network of clinical integration, expertise and technologies through its academic health system, eight medical campuses, tertiary medical center, research and education facilities, community hospitals, physician practices and numerous specialty services. GHS, by itself a 1,627-bed system, is home to 16 medical residency and fellowship programs, as well as partnership efforts such as the University of South Carolina School of Medicine Greenville and the soon-opening Clemson University Center for Nursing, Health Innovation and Research. Visit www.ghs.org for more information.