Press release Communiqué de presse
Press release Communiqué de presse
March 17, 2022 17 March, 2022
Data Safety Monitoring Board Recommends Continuation of Phase 1/2 Clinical Trial with Sernova’s Cell Pouch System™ in Patients with Type-1 Diabetes
Confirms Ongoing Safety and Tolerability of Sernova’s Cell Pouch
March 17, 2022 10:00 a.m. EDT
LONDON, ONTARIO – March 17, 2022 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical- stage company and leader in regenerative medicine cell therapeutics, is pleased to announce that the Data Safety Monitoring Board ("DSMB") has completed the third annual review of Sernova’s ongoing Phase 1/2 clinical study “Safety, Tolerability and Efficacy Study of Sernova’s Cell Pouch for Clinical Islet Transplantation” in patients with Type-1 Diabetes (T1D) who suffer from hypoglycemia unawareness and severe hypoglycemic events.
In their assessment, the DSMB recommended that the clinical study should continue according to the study plan.
The DSMB is an independent committee of clinical experts who review the accumulated trial data to evaluate patient safety and ensure the integrity of the study data.
“This recommendation from the DSMB affirms our understanding of the safety of Cell Pouch in this patient population transplanted with human donor islets. We look forward to sharing updates from the study through upcoming conference presentations by Dr. Piotr Witkowski, the trial Principal Investigator.” said Dr. Philip Toleikis, President & CEO of Sernova Corp.
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 HYPOGLYCEMIA UNAWARENESS Hypoglycemia unawareness is a person’s inability to recognize the symptoms of low blood sugar before they become severe enough to be incapacitating or even fatal, which may occur when blood glucose levels are below 3.0 mmol/L. It is estimated that approximately 15% of people with T1D, or approximately 240,000 people, are affected by hypoglycemia unawareness in the US alone. Severe symptoms of low blood sugar include confusion, slurred speech, impaired motor coordination and personality changes. Individuals experiencing a severe hypoglycemic event can lose their ability for self-care and self-control, requiring urgent intervention from another person to prevent loss of consciousness, seizure, coma, or death. After a person has had a first hypoglycemia unawareness episode, more are likely to occur.
ABOUT SERNOVA Sernova is developing regenerative medicine cell therapeutic solutions using a medical device (Cell Pouch) and immune protected therapeutic cells / tissues (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 cellular production of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM CELL THERAPY PLATFORM 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. After implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the transplantation and function of therapeutic cells, that 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 1/2 clinical trial study at the University of Chicago. Positive initial results have been presented at several international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT: Christopher Barnes VP, Investor Relations Sernova Corp. firstname.lastname@example.org Tel: 519-902-7923 www.sernova.com
Corey Davis, Ph.D. LifeScience Advisors, LLC email@example.com Tel: 212-915-2577
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