Press release Communiqué de presse
Press release Communiqué de presse
April 11, 2019 11 April, 2019
Sernova Announces First Transplantation of Therapeutic Cells in Cell Pouch for the Company Phase I/II U.S. Clinical Study for Diabetes
April 11, 2019, 9:00 a.m. EDT
LONDON, ONTARIO – April 11, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage
regenerative medicine company today announced the first Cell Pouch™ transplant of insulin-producing cells in
its U.S. Phase I/II clinical trial evaluating the safety and efficacy of the Cell Pouch for Clinical Islet
Transplantation in type 1 diabetes.
“Sernova’s Cell Pouch technologies are positioned to provide the most severe patients with improved, long
term options to manage their diabetes,” said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and
Director of the Pancreatic Islet Transplant Program at the University of Chicago. “The current standard of care,
involves islet transplants into the portal vein which has significant limitations including the development of an
immediate blood-mediated inflammatory reaction (IBMIR), limited supply of donor organs and the challenges in
isolating and obtaining a consistent quality of islet preparations.”
In accordance with the study protocol, the Cell Pouch was implanted prior to transplant of purified islets. This
procedure enables the development of vascularized tissue chambers and provides an interval for patient
stabilization on standard immune protection medications. Prior to transplantation, the Cell Pouch was
assessed for safety. A Sentinel Pouch, a small monitoring device, was also transplanted with islets. In
accordance with the protocol the Sentinel Pouch will be removed approximately 90 days post-transplant to
assess islet survival as an interim indicator of efficacy.
“Sernova’s Cell Pouch provides a non-fibrosing, vascularized environment for the transplantation of therapeutic
cells, to enhance the curative potential of islet transplantation and other cell therapies,” said Dr. Philip Toleikis,
President and CEO of Sernova. “We are thrilled with Dr. Witkowski’s progress as well as his decision to move
forward with transplantation based on his analysis of the safety and vascularization of the Cell Pouch.”
“This important clinical milestone advances our Cell Pouch technologies as a valuable enabling foundation for
cell therapies across a range of indications including type 1 diabetes, hemophilia and thyroid disease,” added
Dr. Toleikis.
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 the 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 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
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.