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 email@example.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.