Press release Communiqué de presse
Press release Communiqué de presse
February 11, 2019 11 February, 2019
Sernova Corp Announces First Patient Implanted with Sernova Cell Pouch in a Phase I/II US Clinical Trial for the Treatment of Hypoglycemia Unawareness in Subjects with Type 1 Diabetes
February 11, 2019; 9:00 a.m. EST
LONDON, ONTARIO – February 11, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage
regenerative medicine company today announced the first patient implanted with Sernova’s Cell Pouch™ in the
Phase I/II clinical trial evaluating the safety and efficacy of Sernova’s Cell Pouch™ for Clinical Islet
Transplantation in type 1 diabetes.
“Islet transplantation has shown success as a therapeutic option for treating patients with hypoglycemia
unawareness; the most unstable, high-risk form of type 1 diabetes. Given the limited supply of donor islet
cells, it is imperative to develop approaches that capitalize on a more efficient use of donor islet cells,” said Dr.
Piotr Witkowski principal investigator and Director of the Pancreatic and Islet Transplant Program at University
of Chicago School of Medicine. “We believe Sernova’s Cell Pouch creates a vascularized environment, rich in
microvessels that will allow robust engraftment and extended survival of the transplanted islet cells. We hope
this will result in the need for fewer transplants per patient and, ultimately, create a long-term treatment option
for patients suffering from hypoglycemic unawareness.”
Cell Pouches, including, small sentinel pouches were implanted. Following development of the vascularized
tissue chambers, and stabilization on immune protection medications, the Cell Pouch will be transplanted with
donor islet cells. Approximately 90-days after transplant, small sentinel devices are removed to evaluate islet
survival as an initial efficacy endpoint.
“This important clinical milestone represents an exciting time at Sernova as we pursue safe, effective, and
innovative regenerative medicine treatments for patients with hypoglycemia unawareness in type 1 diabetes,”
said Dr. Philip Toleikis, President and CEO of Sernova Corp. “We are confident this US clinical trial will support
and add important data to the positive pre-clinical results of our small and large diabetes animal models, and
our first-in-human trial with Health Canada. It will also contribute to the development of broader applications
for the Cell Pouch including our diabetes stem cell technologies and additional indications.”
The Company is expecting to report preliminary safety data from Sernova’s clinical study in the first half of
2019 and preliminary efficacy data in the second half of 2019.
About the 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 under informed consent. 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 will be 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 or contact
(773) 702-2504.
About Hypoglycemia Unawareness and Diabetes
Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune
system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body
use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent on
insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with
multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected
variable leading to high or low blood sugar episodes are daily threats, and only a third of people with type 1
diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-related health
complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop
in blood sugar without warning symptoms, represents more than 15% of type 1 diabetes population.
About the 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:
United States: Danny Matthews Solebury Trout Tel: (646) 378-2928 dmatthews@soleburytrout.com
www.soleburytrout.com
For investor inquiries and media inquiries in Canada:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
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.
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.