Sernova Corp (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-stage company and regenerative medicine therapeutics leader, is pleased to announce that Sernova’s first treated patient in its Phase I/II clinical trial of its Cell Pouch with therapeutic cells for type 1 diabetes at the University of Chicago, has demonstrated survival of endocrine tissue (insulin-producing islets) in the sentinel Cell Pouch following 90 days transplant.
This efficacy outcome, namely, survival of endocrine tissue (insulin-producing islets) in the sentinel Cell Pouch following 90 days transplant, is measured by positive staining of islets during histological analysis. According to the independent pathologist who conducted the analysis, “The explanted sentinel pouch shows abundant viable, organized islet cells intimately associated with blood vessels within a collagen matrix after 90 days of transplantation. These surviving islet cells strongly express insulin.”
This achievement is important because it is an indicator of transplanted islet health in the therapeutic Cell Pouches remaining in the subject, including the islets ability to produce insulin into the bloodstream. This has been demonstrated by our previous reported findings of blood levels of both glucose-stimulated and fasting C-peptide as well as other efficacy indicators in this patient who had no measurable levels of this biomarker of insulin prior to the Cell Pouch islet transplant.
“We believe these accumulating positive results continue to validate our Cell Pouch technologies as a viable regenerative medicine therapeutic platform for humans in insulin-dependent diabetes and other chronic diseases,” said Dr. Philip Toleikis, President and CEO of Sernova Corp. “With these encouraging results and the positive review and recommendation from the Data Safety and Monitoring Board (DSMB), we are excited to continue the clinical trial and carry on compiling safety and efficacy data from our current and future treated patients.”