Press release Communiqué de presse
Press release Communiqué de presse
February 10, 2020 10 February, 2020
Sernova Announces Positive DSMB Review and Recommendation for Continuation of Phase I/II Diabetes Clinical Trial of Cell Pouch
Ongoing Safety of Sernova’s Clinical Trial Confirmed
February 10, 2020 9:00 a.m. EDT
LONDON, ONTARIO – February 10, 2020 – Sernova Corp (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage company and leader in regenerative medicine therapeutics is pleased to announce that the independent
Data Safety Monitoring Board (“DSMB”) completed its first interim analysis of the ongoing Safety, Tolerability
and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation Phase I/II clinical trial in patients
with severe hypoglycemia unawareness.
The DSMB did not raise any concerns regarding safety and recommended the continuation of the study.
“We are very pleased with the recommendation of the DSMB. In light of this positive assessment, Sernova
continues the trial as we carry on compiling safety and efficacy results from our treated patients along with
advancing further patient enrollment at the University of Chicago,” said Dr. Philip Toleikis, President and CEO
of Sernova. “We thank the DSMB for its diligence, guidance, and support as we continue moving forward with
our mission to provide people suffering from diabetes and other chronic diseases improved treatment options
and a better quality of life.”
The DSMB is an independent group of clinical research experts who review the accumulated safety data
throughout the clinical trial to safeguard the safety and interests of participating patients while ensuring the
scientific validity and integrity of the trial. This interim analysis was the first of three planned DSMB reviews of
this clinical trial.
ABOUT SERNOVA’S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single-arm, company-sponsored trial to assess
the safety and tolerability of islet transplantation into the company’s patented Cell Pouch in diabetic subjects
with hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of defined
measures. Patients enrolled in Sernova’s clinical trial are incapable of producing c-peptide, a biomarker for
insulin produced by islet cells.
Eligible subjects are 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, transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are 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 be then
further followed for one year to assess longer-term safety and efficacy.
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 SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch system including the Cell Pouch, which is a novel, proprietary, scalable, implantable macro-
encapsulation device solution 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 Cell
Pouch 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. In early assessments of its ongoing Phase I/II clinical trial, Sernova has shown
presence of blood levels of c-peptide both during glucose tolerance tests as well as under fasting conditions.
Clinical testing is ongoing at the University of Chicago.
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:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
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.