Sernova Initiates Patient Screening and Recruitment for its US Clinical Trial for Diabetes
July 05 2018 - 10:50AM
InvestorsHub NewsWire
Sernova Initiates Patient Screening and Recruitment for its US
Clinical Trial for Diabetes
London, ON -- July 5, 2018 -- InvestorsHub
NewsWire -- 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.
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