Mr. Dominic Gray reports
SERNOVA CONFIRMS ENDURING LEVELS OF FASTING C-PEPTIDE IN BLOODSTREAM OF FIRST PATIENT IN ITS PHASE I/II CLINICAL TRIAL FOR TYPE-1 DIABETES
Sernova Corp. (SVA) (SEOVF) has detected enduring levels of C-peptide (measured up to 30 days and continuing), a biomarker of transplanted beta cell insulin production, in the bloodstream of a fasting patient in its continuing phase I/II Cell Pouch United States clinical study of type-1 diabetes.
The detection of fasting C-peptide in the bloodstream of our first patient, in addition to Sernova’s recent announcement of glucose-stimulated C-peptide and other early efficacy indicators, demonstrate a normalizing response of the Cell Pouch therapeutic cells to the body’s varied need for insulin production. This is an important step forward and evidence of ongoing islet engraftment within the Cell Pouch.
“Along with the preliminary safety and early indicators of efficacy, I am excited that we are observing C-peptide levels in the patient’s bloodstream after recent transplant, not only following stimulation with a meal but also when the patient is fasting. These findings represent progress in clinical outcomes and evidence of enduring islet survival and function within Sernova’s Cell Pouch,” said Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study principal investigator. “We look forward to reporting ongoing results in additional patients as the trial progresses.”
The entry criteria of Sernova’s clinical study require patients to be C-peptide negative upon enrolment. C-peptide measured in the bloodstream is a biomarker of insulin and is widely used as a measure of insulin production by islet cells. C-peptide is typically measured following overnight fasting (fasting C-peptide) and during a glucose tolerance test (glucose-stimulated C-peptide). Together these measures provide an index of the patient’s ability to control blood glucose through their production of insulin.
With the goal of improved blood glucose control and stabilization of fluctuating blood sugar levels commonly experienced in people with type-1 diabetes, a normalizing response can also decrease the likelihood of life threatening hypoglycemic unaware events, a key efficacy measure in the Sernova trial.
Sernova’s clinical trial is continuing active recruitment and enrollment of study participants and further results will continue to be reported as the study progresses.
ABOUT SERNOVA’S CLINICAL TRAIL
Sernova is conducting a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, to assess the safety and tolerability of islet transplantation into the company’s patented Cell Pouch in participants with diabetes and hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of defined measures. Importantly, patients enrolled in Sernova’s clinical trial are incapable of producing C-peptide prior to implantation of Sernova’s Cell Pouch and therapeutic cells.
Eligible subjects are implanted with Cell Pouches. Following 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, transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional safety and efficacy measures for approximately six months. At this point, a decision is made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will be then further followed for one year to assess longer-term safety and efficacy.
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’S CELL POUCH
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long- term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans.
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.
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