Press Release - May 08, 2018
Sernova Announces U.S. Phase I/II Cell Pouch Clinical Trial with Prominent Diabetes Clinical Investigator
Leading Surgeon and Researcher in Islet Transplantation at the University of Chicago to
act as Clinical Trial Principal Investigator. Study to focus on severely diabetic patients
with hypoglycemia unawareness
Source: Sernova Corp
May 8, 2018, 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire May 8, 2018) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), announces Dr. Piotr Witkowski, M.D., Ph.D., a leading expert in type 1 diabetes (T1D) and islet transplantation, as the Clinical Trial Principal Investigator for Sernova’s new clinical study. Dr Witkowski, at the University of Chicago site, will work closely with Sernova’s team to conduct the clinical and regulatory aspects of the Cell Pouch trial.
Dr. Witkowski is a widely published diabetes researcher and respected surgeon with a longstanding record of success in both basic science and clinical research pertaining to islet cell and abdominal organ transplantation. Among other accomplishments, he was instrumental in developing an optimized islet isolation technique that greatly improved success in clinical transplants. Under Dr. Witkowski's leadership, multidisciplinary research teams at the University of Chicago are currently conducting several studies designed to improve the quality and outcomes of islet cell transplantation in patients with T1D.
“Sernova’s achievement to commence US human clinical trials is a key step to improving the therapeutic treatment for people living with diabetes. This Cell Pouch safety and efficacy trial aims to reduce the risk of hypoglycemia unawareness, a complication in which a patient is unable to recognize and control impending hypoglycemia resulting in a drop in blood sugar that can have life threatening consequences,” said Dr. Witkowski. “Our experienced diabetes treatment team at the University of Chicago sees the potential of this transformative therapy to benefit and substantially improve the care of T1D.”
“Improving the quality of life and outcomes of people with diabetes are Sernova’s main priorities, and we are grateful to have the opportunity to work with Dr. Witkowski and his expert team at the University of Chicago, a team known for outstanding diabetes research and patient care,” stated Dr. Philip Toleikis, Sernova’s President & CEO.
The study is a Phase I/II, non-randomized, unblinded, single-arm, company sponsored trial. Under the clinical leadership of Dr. Witkowski, University of Chicago Medicine, patients with hypoglycemia unawareness will be enrolled in the study under informed consent. Patients then will be implanted with the Cell Pouch including sentinel devices. Following vascularized tissue development in the Cell Pouch, an initial dose of purified islets under strict release criteria will be transplanted into the Cell Pouch and patients followed for 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, with interim patient results released at periodic intervals consistent with an open label study.
About Dr. Witkowski Piotr Witkowski M.D. Ph.D. is an Associate Professor of Surgery and a transplant surgeon at the University of Chicago Medicine. He has been involved in islet transplantation research for the past 17 years, initially at Columbia University in New York City and then as a Director of the Pancreatic Islet Transplantation Program at the University of Chicago Medicine. For the last nine years, Dr. Witkowski has been conducting multiple clinical studies in intraportal islet allotransplantation in patients with brittle type diabetes as well as islet autotransplantation in patients with chronic pancreatitis. Recently, he accomplished a phase 3 clinical trial and is currently preparing application to the FDA for islet graft as a biological product, which is pivotal to enable islet transplantation to become available to patients as a standard of care procedure. Being aware of shortcomings of intrahepatic islet transplantation, Dr Witkowski has been working on optimization of the subcutaneous location for improved islet engraftment. He has proven the concept that this pre-vascularized site enhances islet survival in a preclinical diabetes model.
About Sernova Corp Sernova Corp is developing disruptive regenerative medical technologies using a medical device (Cell Pouch) and immune protected therapeutic 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: Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939; firstname.lastname@example.org www.sernova.com
Ray Matthews & Associates Tel: (604) 818-7778; www.raymatthews.ca email@example.com
Forward Looking Information 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 belief about the conduct and outcome of clinical trials and that Sernova will be able to raise additional capital to fund its clinical programs including its US FDA clinical trial. 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.
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