Press release Communiqué de presse
Press release Communiqué de presse
October 16, 2019 16 October, 2019
Sernova Confirms Enduring Levels of Fasting C-Peptide in Bloodstream of First Patient in its Phase I/II Clinical Trial for Type-1 Diabetes
Findings further validate Cell Pouch and therapeutic cell performance in Type-1 diabetes
October 16, 2019 9:00 a.m. EDT
LONDON, ONTARIO – October 16, 2019 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage regenerative medicine company, is pleased to announce the detection of enduring levels of C-peptide
(measured up to 30 days and ongoing), a biomarker of transplanted beta cell insulin production, in the
bloodstream of a fasting patient in its ongoing Phase I/II Cell Pouch(TM) US 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 TRIAL
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. For more information, please visit
www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the date such statements were made, which include our beliefs about the conduct and outcome of clinical
trials. The information disclosed represents results from one patient and may not be representative of all study
patients or of the final study results. Sernova expressly disclaims any intention or obligation to update or revise
any forward-looking statements whether as a result of new information, future events or otherwise.