| LONDON, ONTARIO - TheNewswire - July 3, 2019 - Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF), a clinical-stage regenerative medicine company today announced that in an interim analysis of its human Phase I/II clinical trial, Sernova's Cell Pouch transplanted with islet cells showed initial safety, as well as key efficacy measures, including glucose-stimulated C-peptide, insulin production and additional clinically significant measures of glucose control in the first study patient with type-1 diabetes and severe hypoglycemia unawareness. Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study principal investigator presented on Sernova's Cell Pouch technology and preliminary data from Sernova's current clinical trial: A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch for Clinical Islet Transplantation today at the 17th World Congress of the International Pancreas and Islet Transplantation Association (IPITA) in Lyon, France. Highlights of the presentation of the data from the first patient who received islet transplanted into Sernova Cell Pouch included:- No incidences of adverse events determined to be related to the Cell Pouch implant.- The Cell Pouch was well-incorporated with vascularized tissue, which enabled successful transplant of the purified islets- A weight reduction of 6.35kg (12% total body weight)- Stabilizing improvements in all glycemic control parameters as indicated by Continuous Glucose Monitoring (CGM) as assessed by Medtronic- 87.5% reduction in hypoglycemic events from baseline collected over a two-week monitoring period- Presence of stimulated blood levels of C-peptide and insulin at the observed 90-day post-transplant point as indicated in a mixed meal tolerance test "I am quite pleased with these interim results in the first implanted patient," said Dr. Witkowski. "The first of two doses of islets transplanted into the Cell Pouch is showing safety and early indicators of efficacy. Importantly, demonstration of glucose-stimulated C-peptide and insulin present in the bloodstream is definitive proof of islet survival and function in the Cell Pouch. These results are an important first step towards a paradigm shift in the treatment of this debilitating disease. Our team is looking forward to reporting longer-term results in enrolled patients as the trial progresses," said Dr. Witkowski, principal study investigator. |
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