Dr. Conaway (left) and Dr. Petroni
Mark Conaway, PhD, professor of in the Department of Public Health Sciences, and Gina Petroni, PhD, professor and director for the Division of Translational Research and Applied Statistics in the Department of Public Health Sciences, have been awarded a four-year, $1.95 million NIH R01 grant to investigate two significant clinical questions: 1) how should ELISpot assay data be used in early phase clinical trials to identify potentially effective therapies and 2) can ELISpot assay data predict longer term clinical benefit.
“This project proposes an improvement to the way cancer vaccines are evaluated in early stage trials, enabling ineffective therapies to be discarded early in the drug development process,” said Dr. Petroni. “It will also enable effective therapies to move more rapidly through the drug development process, giving patients in the population earlier access to safe and effective therapies.
The enzyme-linked immunospot (ELISpot) assay is used to quantify the number of cytokine secreting cells and is a primary assessment tool of numerous basic, clinical and translational studies. The results of an ELISpot assay can be used as an outcome in early stage trials for comparing the immunogenicity of different therapies or as a short-term indicator of long-term clinical benefit of an immunotherapy. The goals are to develop statistical methodology for the assessment of results from ELISpot assays measured over time and a statistically rigorous method to account for positive and negative controls; and to develop methods for analyzing multiple targeted T cell specific responses as composite outcomes.
Additional research team members from the University of Virginia include Craig Slingluff, Jr., MD, and Kimberly Bullock, PhD, in the Department of Surgery, and Linda Duska, MD, in the Department of Obstetrics and Gynecology.
Filed Under: Research