Sernova Highlights Positive Results Presented at the American Diabetes Association's Virtual 80th Scientific Sessions
LONDON, ONTARIO - TheNewswire - June 18, 2020 - Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE:PSH), a clinical-stage regenerative medicine therapeutics company, highlights positive results from its submitted abstract entitled "Clinical Validation of the Implanted Pre-Vascularized Cell Pouch(TM) as a Viable, Safe Site for Diabetes Cell Therapy," selected for presentation at the American Diabetes Association's (ADA) 80th Scientific Sessions held virtually June 12-16, 2020.
"Sernova was honored that its abstract was selected under peer review to be presented at the prestigious ADA Scientific Sessions. The findings reported in diabetic patients, demonstrate that human donor islets transplanted into Sernova's Cell Pouch consistently demonstrate islet survival and the ability to produce the array of hormones required to treat diabetes," said Dr. Philip Toleikis, President and CEO of Sernova.
The following provides the background of our scientific presentation:
Cellular transplantation therapy has the potential to treat severe, chronic diseases such as Type 1 Diabetes (T1D). The transplantation site and device approach are major factors influencing successful clinical outcomes;
With new cell-based emerging technologies, there continues to be a need to find a safe, retrievable, biologically compatible device for cellular transplantation and we believe Sernova's Cell Pouch System may provide such a solution;
The transplantation of insulin-producing islets is a cellular replacement therapy for severe T1D in patients who experience life-threatening severe hypoglycemia unawareness events;
In this clinical indication, Sernova has conducted a physician sponsored first-in-human study in Canada and currently has an ongoing company-sponsored Phase I/II human clinical study at the University of Chicago. In both clinical studies, patients with T1D were implanted with both sentinel (small devices removed to assess cell survival) and larger therapeutic devices, anywhere between 1 to 6 months;
After being placed on immunosuppression, islets were isolated from donor pancreata and transplanted into patients within the device chambers. When possible, a pre-transplant sample of islets was saved for comparison to post-explant Cell Pouch islets; and
Cell Pouches were explanted from patients, anywhere between 14-90 days post-transplant. The Cell Pouches were prepared, and sections were stained and imaged, and then reviewed by an independent clinical pathologist to assess the transplanted tissue for micro-vessel formation and vascularization; the presence of islets with insulin, C-peptide, and other endocrine hormones (such as glucagon and somatostatin); and exocrine tissue (such as pancreatic ductal tissue).
The data presented clinically demonstrate that the vascularized Cell Pouch provides a consistently safe and biologically suitable, retrievable environment for the transplantation and survival of functional islets. Specific findings based on a detailed histopathological analysis of nine Sernova Cell Pouches explanted from patients with T1D diabetes include:
Explanted Cell Pouches show abundant, viable, organized islet cells intimately associated with blood vessels within a natural collagen matrix following transplantation without obvious rejection or infection; - 100% showed present or abundant blood vessels; - 89% showed present or abundant insulin; - 78% showed present or abundant endocrine cells; - 100% showed present or abundant ductal tissue;
Islet cells required to control diabetes within the Cell Pouches consistently express insulin and other endocrine hormones, such as glucagon, somatostatin, and C-peptide, when identified histologically;
Pre-transplant islet samples that show strongly expressed insulin, as well as other endocrine markers, were similarly identified in the explanted Cell Pouches following transplant; and
The amount of islet/exocrine tissue within pre-transplanted samples was similar to that found in the Cell Pouch following transplantation.
In summary, the transplanted samples, when explanted and examined, demonstrate healthy, surviving islets with multiple cell types within the islets capable of producing the hormones that control blood sugar levels when housed in the vascularized tissue matrix of the Cell Pouch. Exocrine ductal tissue, when transplanted, also survived. The findings demonstrate the pre-transplant samples are consistent with the histology observed upon explantation of the Cell Pouch at different time points. These clinical findings demonstrate that the Cell Pouch is a viable, safe site for diabetes cell therapy.
Dr. Toleikis said, "The positive results reported in patients in this diabetes indication, implanted with Sernova's Cell Pouch and transplanted with islets, continue to validate our Cell Pouch System cell therapy therapeutics approach. Within the emerging cell therapy field, Sernova, with its advancing cell therapies including locally immune protected stem cell-derived cells, continues to position itself as a leader in the development of a 'functional cure' for all patients with diabetes and other chronic diseases."
A recording of Sernova's ADA Scientific Session presentation is available at www.sernova.com/updates.
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.
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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.
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