Press release Communiqué de presse
Press release Communiqué de presse
July 3, 2019 3 July, 2019
Sernova Corp Presents Positive Preliminary Safety and Efficacy Data in its Phase I/II Clinical Trial for Type-1 Diabetes
Sernova’s Cell Pouch (TM) with transplanted islet cells reached primary safety measurements and clinically
significant efficacy outcomes including glucose-stimulated C-peptide and the release of insulin in the first
July 3, 2019 5:30 a.m. EDT
LONDON, ONTARIO – July 3, 2019 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF), a clinical-stage regenerative medicine company today announced that in an interim analysis of its human Phase I/II clinical trial, Sernova’s Cell Pouch transplanted with islet cells showed initial safety, as well as key efficacy measures, including glucose stimulated C-peptide, insulin production and additional clinically significant measures of glucose control in the first study patient with type-1 diabetes and severe hypoglycemia unawareness.
Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study principal investigator presented on Sernova’s Cell Pouch technology and preliminary data from Sernova’s current clinical trial: A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch for Clinical Islet Transplantation today at the 17th World Congress of the International Pancreas and Islet Transplantation Association (IPITA) in Lyon, France.
Highlights of the presentation of the data from the first patient who received islet transplanted into Sernova Cell Pouch included:
• No incidences of adverse events determined to be related to the Cell Pouch implant.
• The Cell Pouch was well-incorporated with vascularized tissue, which enabled successful transplant of the purified islets
• A weight reduction of 6.35kg (12% total body weight)
• Stabilizing improvements in all glycemic control parameters as indicated by Continuous Glucose Monitoring (CGM) as assessed by Medtronic
• 87.5% reduction in hypoglycemic events from baseline collected over a two-week monitoring period
• Presence of stimulated blood levels of C-peptide and insulin at the observed 90-day post-transplant point as indicated in a mixed meal tolerance test
“I am quite pleased with these interim results in the first implanted patient,” said Dr. Witkowski. “The first of two doses of islets transplanted into the Cell Pouch is showing safety and early indicators of efficacy. Importantly, demonstration of glucose-stimulated C-peptide and insulin present in the bloodstream is definitive proof of islet survival and function in the Cell Pouch. These results are an important first step towards a paradigm shift in the treatment of this debilitating disease. Our team is looking forward to reporting longer- term results in enrolled patients as the trial progresses,” said Dr. Witkowski, principal study investigator.
The International Pancreas and Islet Transplantation Association aims to serve the pancreas and islet transplant scientific community in providing a forum for the open exchange of knowledge and expertise in order to facilitate the advancement of the clinical practice of pancreas and islet transplantation for the treatment of human diabetes.( https://www.tts.org/ipita/home)
ABOUT THE STUDY
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study. Participants are then 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 will be 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 then be further followed for one year. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures.
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 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: United States: Danny Matthews Solebury Trout Tel: (646) 378-2928 firstname.lastname@example.org www.soleburytrout.com
For investor inquiries and media inquiries in Canada: Dominic Gray Sernova Corp Tel: (519) 858-5126 email@example.com www.sernova.com
Ray Matthews & Associates Tel: (604) 818-7778 firstname.lastname@example.org www.raymatthews.ca
This release may contain forward-looking statements. Forward-looking statements 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. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the date such statements were made, which include our beliefs about the conduct and outcome of clinical trials. 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.