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Sernova's Phase I/II US Clinical Trial for Type-1 Diabetes Advances Following Positive Preliminary Safety and Efficacy Data
(via TheNewswire) CEO to participate in conference call with Sernova Share...
About this update from Sernova Biotherapeutics Inc
[{"type":"text","content":"Sernova's Phase I/II US Clinical Trial for Type-1 Diabetes Advances Following Positive Preliminary Safety and Efficacy Data(via TheNewswire)\n \n \nCEO to participate in conference call with Sernova Shareholders on July 18 at 10:00 am (EDT)\n\n\n \nLONDON, ONTARIO - TheNewswire - July 17, 2019 - Sernova Corp. (TSXV:SVA) (FSE:PSH) (OTCQB:SEOVF), a clinical-stage regenerative medicine company today announced that its human Phase I/II clinical trial for type-1 diabetes is advancing with additional patients for device and cell transplantation. \n\n\n \nSernova announced on July 3, 2019, a case study describing preliminary data from its current clinical trial: A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch for Clinical Islet Transplantation. Sernova's Cell Pouch transplanted with islet cells demonstrated initial safety, as well as key efficacy measures, including glucose-stimulated blood levels of C-peptide, insulin, and additional measures of glucose control in the first study patient with type-1 diabetes and severe hypoglycemia unawareness.\n\n\n \nA summary of the data presented at the International Pancreas and Islet Transplantation Association (IPITA) World Congress is as follows:\n\n\n \n- No incidences of adverse events determined to be related to the Cell Pouch implant. \n\n\n \n- The Cell Pouch was well-incorporated with vascularized tissue, which enabled successful transplant of the purified islets\n\n\n \n- A reduction in body weight \n\n\n \n- Stabilizing improvements in glycemic control parameters measured by Continuous Glucose Monitoring (CGM), assessed by Medtronic\n\n\n \n- 87.5% reduction in hypoglycemic events from baseline collected over a two-week CGM monitoring period\n\n\n \n- 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\n\n\n \n\"I am pleased with these interim results in the first implanted patient,\" said Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study principal investigator. \"The first dose of islets transplanted into the Cell Pouch has shown safety and early indicators of potential efficacy. We found some glucose-stimulated C-peptide and insulin present in the bloodstream, which are the gold standard indicators of islet ...