Press release Communiqué de presse
Press release Communiqué de presse
July 5, 2018 5 July, 2018
Sernova Initiates Patient Screening and Recruitment for its US Clinical Trial for Diabetes
Source: Sernova Corp
July 5, 2018, 6:00 a.m. EDT
LONDON, ONTARIO –July 5, 2018 – Sernova Corp.
(“Sernova” or the “Company”)
(TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH)
announces that patient screening and
recruitment has begun in its regenerative medicine
US clinical trial for diabetic patients
with hypoglycemia unawareness.
Sernova’s initial clinical evaluation of the
prevascularized Cell Pouch (TM) demonstrated
biocompatibility and safety of the Cell Pouch as well
as viability and vascularization of its
transplanted insulin-producing islets, a first in world
achievement in a prevascularized
implantable medical device.
“This first-in-human work helped frame the design
of Sernova’s new Phase I/II clinical
protocol. Our clinical team at the University of
Chicago is excited to initiate this trial of
Sernova’s transformative technology,” said
principal investigator, Dr. Piotr Witkowski,
M.D., Ph.D.
“To support the clinical study’s timely execution
under the highest quality standards,
Sernova and CTI (Clinical Trial and Consulting), a
well-respected clinical research
organization with deep experience in the
regenerative medicine field, are working
closely with Dr. Witkowski’s team,” said Dr. Philip
Toleikis, Sernova’s President and
CEO.
The study is a Phase I/II, non-randomized, open
label, single-arm, company-sponsored
trial. Under the clinical leadership of Dr. Witkowski,
University of Chicago Medicine,
subjects with hypoglycemia unawareness enrolled
in the study under informed consent
will be implanted with the Cell Pouch. Following
vascularized tissue development in the
Cell Pouch, an initial dose of purified islets under
strict release criteria will be
transplanted into the Cell Pouch.
A sentinel pouch, also transplanted with islets, will
be removed for an early assessment
of the islet transplant. Subjects will be followed for
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. Subjects
will then be further followed for one year, with
interim participants results released at
periodic intervals consistent with an open-label
study.
About Sernova’s Cell Pouch Technologies
The Cell Pouch is a novel, proprietary, scalable,
implantable prevascularized
macroencapsulation device for the long-term
survival and function of therapeutic cells
(donor, stem cell derived cells and xenogeneic cells)
which then release proteins and/or
hormones as required to treat disease. The device
is designed to eliminate concerns of
fibrosis upon implantation by incorporating with
tissue, forming highly vascularized
tissue chambers for the transplantation and function
of therapeutic cells. The device 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 Diabetes
Type1 Diabetes (T1D) is a life-threatening disease
in which the body's immune system
mistakenly attacks and kills the pancreatic cells that
produce insulin—a hormone that is
essential for life because of its role to help the body
use glucose. The existing standard of
care for patients with TID is suboptimal. To date,
there is no cure for T1D, and people
living with the disease are dependent on exogenous
insulin therapy to help keep their
blood-sugar levels from spiking too high, which can
lead to long-term complications such
as kidney and heart diseases or an acute,
potentially deadly health crisis. Present-day
insulin therapy is, however, an imperfect treatment
method that requires people with
T1D to carefully monitor their blood sugar
throughout the day and take multiple,
calculated doses of insulin based on food intake,
exercise, stress, illness and other
factors. A miscalculation or unexpected variable
leading to high or low blood sugar
episodes are daily threats, and only a third of
people with T1D achieve their long-term
blood glucose targets, placing them at risk for T1D-
related health complications.
About Sernova Corp
Sernova Corp is developing regenerative medicine
therapeutic technologies using an
implantable medical device and immune protected
therapeutic 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:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
Philip.toleikis@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 belief about the conduct
and outcome of clinical trials and that
Sernova will be able to raise additional capital to
fund its clinical programs including its
planned US clinical trial. 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.