Sernova Achieves Positive Efficacy Endpoint in Phase I/II Clinical Trial for Type 1 DiabetesMost 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 firstname.lastname@example.org www.sernova.com
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.