Press release Communiqué de presse
Press release Communiqué de presse
February 13, 2020 13 February, 2020
Sernova Achieves Positive Efficacy Endpoint in Phase I/II Clinical Trial for Type 1 Diabetes
Most advanced subject in the clinical trial continues to show positive indicators of islet function following
islet
transplant into the Cell Pouch
February 13, 2020 9:00 a.m. EDT
LONDON, ONTARIO – February 13, 2020 – Sernova Corp (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a
clinical-
stage company and regenerative medicine therapeutics leader, is pleased to announce that Sernova’s first
treated patient in its Phase I/II clinical trial of its Cell Pouch with therapeutic cells for type 1 diabetes at the
University of Chicago, has demonstrated survival of endocrine tissue (insulin-producing islets) in the sentinel
Cell Pouch following 90 days transplant.
This efficacy outcome, namely, survival of endocrine tissue (insulin-producing islets) in the sentinel Cell
Pouch
following 90 days transplant, is measured by positive staining of islets during histological analysis. According
to
the independent pathologist who conducted the analysis, “The explanted sentinel pouch shows abundant
viable, organized islet cells intimately associated with blood vessels within a collagen matrix after 90 days of
transplantation. These surviving islet cells strongly express insulin.”
A representative histological image from the islet-transplanted mini-sentinel Cell Pouch explanted from a
patient at 90 days post-transplant. Islets with positive insulin staining (red), and new blood vessels (green)
are
detected. (A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet
Transplantation.)
This achievement is important because it is an indicator of transplanted islet health in the therapeutic Cell
Pouches remaining in the subject, including the islets ability to produce insulin into the bloodstream. This
has
been demonstrated by our previous reported findings of blood levels of both glucose-stimulated and fasting
C-
peptide as well as other efficacy indicators in this patient who had no measurable levels of this biomarker of
insulin prior to the Cell Pouch islet transplant.
“We believe these accumulating positive results continue to validate our Cell Pouch technologies as a viable
regenerative medicine therapeutic platform for humans in insulin-dependent diabetes and other chronic
diseases,” said Dr. Philip Toleikis, President and CEO of Sernova Corp. “With these encouraging results and
the
positive review and recommendation from the Data Safety and Monitoring Board (DSMB), we are excited to
continue the clinical trial and carry on compiling safety and efficacy data from our current and future treated
patients.”
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 primary objective of the study is to assess the safety of the Cell Pouch
following implantation and transplantation. 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, is 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 the 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
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 early assessments of its ongoing Phase I/II clinical
trial,
Sernova has shown in its first treated patient 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 press release contains forward-looking statements within the meaning of applicable Canadian securities
laws. Forward-looking statements in this press release 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. Forward-looking statements include statements about subsequent clinical
activity,
including enrolment of patients and continuing results therefrom, and the potential benefits, safety, and
efficacy
of the Cell Pouch for various indications, including type 1 diabetes.
While Sernova considers these assumptions to be reasonable, these assumptions are inherently subject to
significant scientific, business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors that could cause Sernova’s actual results,
performance
or achievements to be materially different from any future results, performance or achievements expressed
or
implied by the forward-looking statements contained in this press release. Results in early-stage clinical
trials
may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure
regulatory approval. Readers should not place undue reliance on these statements or the scientific data
presented and should refer to the risk factors identified in the company’s continuous disclosure filed on
SEDAR.
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.