The long term objective of this proposal is to establish a commercial source of immuno-hematologic reagents that will permit early diagnosis of hematopoietic diseases that result from subclinical hepatic dysfunction. Subclinical hepatic disease is reflected by myelpphthisic disease and hypoproliferative anemia attendant upon the release of enzymes or factors into the circulation that influence the production and/or release of hematopoietic growth factor,lymphokines or cytokines. These hematopoietic factors, or moieties include reagents specifically designed to detect low levels of circulating hepatic molecules that may be released into the circulation as a result of primary hepatocellular carcinoma, metastatic hepatic tumors or other hepatic disease. These important reagents would have world-wide utility and could save thousand of lives annually through early detection of hematological pancytopenias associated with liver dysfunction. Our Phase I studies have documented the development of such highly specific hematologic reagents and Phase II seeks to clearly establish the immuno-hematopoietic linkage discovered in Phase I. This will then be deployed in Phase II and Phase III in clinical collaborations.
Specific aims for Phase II include purification of the immunologicre agents developed in Phase I and the development of a sensitive in vitro assay for the serodiagnosis of circulating hepatic factors. Phase II development will include final commercialization of these reagents with appropriate drug company investment and involvement.
