HemoShear Therapeutics, LLC — Department of Health and Human Services SBIR Phase II: 300

Description

DESCRIPTION provided by applicant Drug induced vascular injury DIVI is a common phenomenon in pre clinical animal studies and is typically characterized by hemorrhage vascular endothelial and smooth muscle cell necrosis medial blood cell infiltration and inflammation Mechanisms underlying DIVI are not well understood for several reasons A DIVI result in a preclinical GLP animal study can interrupt or stop the progression of a promising drug to the clinic In addition GLP safety studies in non human primates required to de risk early DIVI findings in lower species are costly HemoShear LLC is a biotechnology research company that utilizes patented methodologies US to restore in vivo biology to animal and human primary cells in co culture in vitro The HemoShear vascular system exposes primary endothelial cells to vascular region specific hemodynamics in co culture with primary smooth muscle cells In this system vascular cells are rescued from a non physiological andquot stateandquot as indicated by restoration of region specific in vivo morphology and function Importantly cells in the HemoShear system demonstrate an efficacious or toxic response to drugs at concentrations that approximate in vivo animal or human exposure levels which are often to orders of magnitude different from standard D static cell culture systems HemoShearandapos s preliminary data with known DIVI compounds show that our science can predict unforeseen DIVI in vitro and prior to pre clinical GLP studies In HemoShear received the Tibbetts SBIR Award from the Small Business Administration for commercialization of innovation The purpose of this SBIR is to further validate the HemoShear DIVI platform for routine commercial application and prospective decision making in pre clinical drug discovery and development PUBLIC HEALTH RELEVANCE Drug induced vascular injury DIVI is a common phenomenon in pre clinical animal studies and is typically characterized by hemorrhage vascular endothelial and smooth muscle cell necrosis medial blood cell infiltration and inflammation Mechanisms underlying DIVI are not well understood for several reasons A DIVI result in a preclinical GLP animal study can interrupt or stop the progression of a promising drug to the clinic HemoShear LLC is a biotechnology research company that utilizes patented methodologies US to restore in vivo biology to animal and human primary cells in co culture in vitro HemoShearandapos s preliminary data with known DIVI compounds show that our science can predict unforeseen DIVI in vitro and prior to pre clinical GLP studies In HemoShear received the Tibbetts SBIR Award from the Small Business Administration for commercialization of innovation The purpose of this SBIR is to further validate the HemoShear DIVI platform for routine commercial application and prospective decision making in pre clinical drug discovery and development