Press release Communiqué de presse
Press release Communiqué de presse
June 3, 2020 3 June, 2020
Sernova to Present Clinical Validation of the Cell Pouch as a Viable, Safe Site for Diabetes Cell Therapy at the American Diabetes Association Virtual 80th Scientific Sessions
LONDON, ONTARIO – June 3, 2020 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-stage
regenerative medicine therapeutics company, is pleased to announce that its submitted abstract entitled
“Clinical Validation of the Implanted Pre-Vascularized Cell Pouch as a Viable, Safe Site for Diabetes Cell
Therapy” has been selected for presentation at the upcoming American Diabetes Association’s (ADA) Virtual
80th Scientific Sessions to be held June 12-16, 2020. Sernova’s presentation (ePoster 205-LB) will be available
to conference attendees beginning June 13, 2020, at 11:00 am EDT.
“We are pleased to have the opportunity to present these scientific results at the ADA’s Virtual 80th Scientific
Sessions,“ said Dr. Philip Toleikis, President and CEO of Sernova.
All information contained in the submitted abstract should be considered preliminary and subject to change
until the study is fully presented at the 80th Scientific Sessions. All information is subject to embargo until June
13, 2020, at 11:00 am EDT.
ABOUT SERNOVA’S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single-arm, company-sponsored trial at the
University of Chicago 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, are 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 is made with regard to the
transplant of a second islet dose with subsequent safety and efficacy follow up. Patients are 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, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation 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 a Canadian first-in-human study. Sernova is currently
conducting a Phase I/II study 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, PLEASE CONTACT:
Dominic Gray
Sernova Corp.
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and/or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. 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.