Press release Communiqué de presse
Press release Communiqué de presse
May 14, 2018 14 May, 2018
Sernova Announces University of Chicago Institutional Review Board (IRB) Approval of the FDA-cleared Therapeutic Cell Pouch Clinical Study
IRB Approval Signals ‘Green Light‘ for Sernova’s Clinical Protocol to Proceed
Source: Sernova Corp
May 14, 2018 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire – Monday May 14, 2018 ) – Sernova Corp.
(TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), announces today it has received University
of Chicago Institutional Review Board (IRB) approval to begin a new clinical protocol for
the FDA-cleared human clinical trial to investigate the Cell Pouch™ for treatment of type
1 diabetes (T1D) in individuals with hypoglycemia unawareness.
The University of Chicago Institutional Review Board (IRB) is a committee established to
review and approve research involving human subjects. The purpose of the IRB is to
ensure that all human subject research is conducted in accordance with all federal,
institutional, and ethical guidelines. The primary goal of an IRB is to safeguard the rights,
safety and welfare of participants in research studies.
"The approval of our clinical protocol by the University of Chicago IRB represents a
significant milestone enabling the company to expand the clinical testing of our Cell
Pouch System to the US. Patient selection and enrollment can now proceed," said Dr.
Philip Toleikis, Sernova President and CEO.
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-
sponsored trial, where diabetic subjects with hypoglycemia unawareness will be enrolled
into the study under informed consent. Subjects will then be implanted with Cell Pouches.
Following development of vascularized tissue chambers within the Cell Pouch, subjects
will then be stabilized on immunosuppression and a 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. 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.
About Sernova’s Cell Pouch™ Technologies
The Cell Pouch™ is a novel, proprietary, scalable, implantable macroencapsulation
device designed to prevent device fibrosis 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 upon
implantation to incorporate 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
T1D is a life-threatening disease, affecting more than 3.3 million individuals in Canada
and US, 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 disruptive regenerative medical technologies using a
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. 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; www.raymatthews.ca
ray@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 FDA 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.