Sernova Announces University of Chicago Institutional Review Board (IRB) Approval of the FDA-cleared Therapeutic Cell Pouch C...
May 14 2018 - 6:00AM
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.
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