Press release Communiqué de presse
Press release Communiqué de presse
January 17, 2019 17 January, 2019
Sernova Announces Successful Enrollment Approaching 50% of Subjects in its U.S. Phase I/II Cell Pouch Diabetes Clinical Trial
January 17, 2019 9:00 a.m. EST
LONDON, ONTARIO – January 17, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company today announced the enrollment of the first three of seven subjects in its Phase I/II trial of Sernova’s Cell Pouch™ for Clinical Islet Transplantation in type 1 diabetes.
“We are pleased to report we are on track with patient enrollment in the Sernova Cell Pouch study for type 1 diabetes,” stated Dr. Piotr Witkowski, principal investigator and Director of the Pancreatic and Islet Transplant Program at University of Chicago School of Medicine. “The Cell Pouch System is designed to improve the quality of life of people with diabetes and this milestone marks an important step towards building further validation of Sernova’s innovative approach to diabetes treatment.”
Sernova is expecting to report preliminary safety data from this landmark clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.
About the Study
The FDA allowed protocol is a Phase I/II non-randomized, open label, single arm, company-sponsored trial, where up to seven diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. 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 including reduction in severe hypoglycemic events and HbA1c as well as survival of islets following transplant into the Cell Pouch. Study subjects will receive Sernova’s Cell Pouches including a small sentinel device implanted under the skin. Following a defined period to allow for the development of vascularized tissue chambers within the Cell Pouch, subjects will be stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, will be transplanted into the Cell Pouch.
The sentinel Cell Pouch will be removed after approximately 90 days to allow for an early assessment of islet survival in the device. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regard to the transplant of a second dose of purified islets. Patients will then be further followed to assess safety and efficacy for up to one year.
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 or contact (773) 702-2504.
Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-related health complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop in blood sugar without warning symptoms, represents more than 15% of type 1 diabetes population.
About the Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long- term survival and function of therapeutic cells. The device 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 device 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.
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 email@example.com www.soleburytrout.com
Canada: Dominic Gray Sernova Corp Tel: (519) 858-5126 firstname.lastname@example.org www.sernova.com
Ray Matthews & Associates Tel: (604) 818-7778 email@example.com 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.