Sernova Corp, a clinical-stage regenerative medicine company announced that its human Phase I/II clinical trial for type-1 diabetes is advancing with additional patients for device and cell transplantation.
Sernova 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.
A summary of the data presented at the International Pancreas and Islet Transplantation Association (IPITA) World Congress is as follows
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 reduction in body weight
• Stabilizing improvements in glycemic control parameters measured by Continuous Glucose Monitoring (CGM), assessed by Medtronic
• 87.5% reduction in hypoglycemic events from baseline collected over a two-week CGM 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 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 function. Our team continues the research and looks forward to reporting longer-term results in additional patients as the trial progresses.”
“The preliminary clinical data achieved in this patient with our pre-vascularized implanted Cell Pouch represent an early clinical validation for our regenerative medicine technologies as we pursue safe, efficacious, and transformative treatments for patients with hypoglycemia unawareness in type-1 diabetes,” said Dr. Philip Toleikis, President and CEO of Sernova Corp. “With these data from our current clinical trial, in conjunction with our advancing hemophilia A, hypothyroid, and diabetes stem cell programs, we believe Sernova is closer to achieving significant advancements in regenerative medicine treatment.”
The Company continue actively recruiting and enrolling subjects and is expecting to report further data from Sernova’s clinical study in the second half of 2019.
ABOUT THE US CLINICAL STUDY
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.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details, please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA CORP.
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