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Sernova Announces Successful Enrollment Approaching 50% of Subjects in its U.S. Phase I of II Cell Pouch Diabetes Clinical Trial
(via TheNewswire) LONDON, ONTARIO / TheNewswire / January 17, 2019 - S...
About this update from Sernova Biotherapeutics Inc
[{"type":"text","content":"Sernova Announces Successful Enrollment Approaching 50% of Subjects in its U.S. Phase I of II Cell Pouch Diabetes Clinical Trial(via TheNewswire)\n \n \nLONDON, ONTARIO / TheNewswire / January 17, 2019 - Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company today announced the enrollment of the first three of seven subjects in its Phase I/II trial of Sernova's Cell Pouch(TM) for Clinical Islet Transplantation in type 1 diabetes.\n\n\n \n\"We are pleased to report we are on track with patient enrollment in the Sernova Cell Pouch study for type 1 diabetes,\" stated Dr. Piotr Witkowski, principal investigator and Director of the Pancreatic and Islet Transplant Program at University of Chicago School of Medicine. \"The Cell Pouch System is designed to improve the quality of life of people with diabetes and this milestone marks an important step towards building further validation of Sernova's innovative approach to diabetes treatment.\" \n\n\n \nSernova is expecting to report preliminary safety data from this landmark clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.\n\n\n \nAbout the Study\n\n\n \nThe FDA allowed protocol is a Phase I/II non-randomized, open label, single arm, company-sponsored trial, where up to seven diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures including reduction in severe hypoglycemic events and HbA1c as well as survival of islets following transplant into the Cell Pouch. \n\n\n \nStudy subjects will receive Sernova's Cell Pouches including a small sentinel device implanted under the skin. Following a defined period to allow for the development of vascularized tissue chambers within the Cell Pouch, subjects will be stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, will be transplanted into the Cell Pouch. \n\n\n \nThe sentinel Cell Pouch will be removed after approximately 90 days to allow for an early assessment of islet survival in the device. Subjects will be followed for additional safety and efficacy measures for approximately s...