Sernova Corp Presents Positive Preliminary Safety and Efficacy Data in its Phase I/II Clinical Trial for Type-1 Diabetes

Sernova Corp., 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.

The International Pancreas and Islet Transplantation Association aims to serve the pancreas and islet transplant scientific community in providing a forum for the open exchange of knowledge and expertise in order to facilitate the advancement of the clinical practice of pancreas and islet transplantation for the treatment of human diabetes. ( https://www.tts.org/ipita/home)

The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study. Participants are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch.

A sentinel pouch is removed for an early assessment of the islet transplant. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year. 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.

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com

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