Sernova Announces First Transplantation of Therapeutic Cells in Cell Pouch for the Company's Phase I/II U.S. Clinical Study for Diabetes.
LONDON, ONTARIO / TheNewswire / April 11, 2019 - Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company today announced the first Cell Pouch(TM) transplant of insulin-producing cells in its U.S. Phase I/II clinical trial evaluating the safety and efficacy of the Cell Pouch for Clinical Islet Transplantation in type 1 diabetes.
"Sernova's Cell Pouch technologies are positioned to provide the most severe patients with improved, long-term options to manage their diabetes, said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and Director of the Pancreatic Islet Transplant Program at the University of Chicago. "The current standard of care, involves islet transplants into the portal vein which has significant limitations including the development of an immediate blood-mediated inflammatory reaction (IBRM), limited supply of donor organs and the challenges in isolating and obtaining a consistent quality of islet preparations."
In accordance with the study protocol, the Cell Pouch was implanted prior to transplant of purified islets. This procedure enables the development of vascularized tissue chambers and provides an interval for patient stabilization on standard immune protection medications. Prior to transplantation, the Cell Pouch was assessed for safety. A Sentinel Pouch, a small monitoring device, was also transplanted with islets. In accordance with the protocol the Sentinel Pouch will be removed approximately 90 days post-transplant to assess islet survival as an interim indicator of efficacy.
"Sernova's Cell Pouch provides a non-fibrosing, vascularized environment for the transplantation of therapeutic cells, to enhance the curative potential of islet transplantation and other cell therapies," said Dr. Philip Toleikis, President and CEO of Sernova. "We are thrilled with Dr. Witkowski's progress as well as his decision to move forward with transplantation based on his analysis of the safety and vascularization of the Cell Pouch."
"This important clinical milestone advances our Cell Pouch technologies as a valuable enabling foundation for cell therapies across a range of indications including type 1 diabetes, hemophilia and thyroid disease," added Dr. Toleikis.
The Company is expecting to report preliminary safety data from Sernova's clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.
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 under informed consent. 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 will be 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 the 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 or contact (773) 702-2504.
About Hypoglycemia Unawareness and Diabetes
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:
Tel: (646) 378-2928
Tel: (519) 858-5126
Ray Matthews & Associates
Tel: (604) 818-7778
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.