Press release Communiqué de presse
Press release Communiqué de presse
July 4, 2018 4 July, 2018
Sernova Initiates Patient Screening and Recruitment for its US Clinical Trial for Diabetes
Source: Sernova Corp
July 5, 2018, 6:00 a.m. EDT
LONDON, ONTARIO –July 5, 2018 – Sernova Corp. (“Sernova” or the “Company”) (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH) announces that patient screening and recruitment has begun in its regenerative medicine US clinical trial for diabetic patients with hypoglycemia unawareness.
Sernova’s initial clinical evaluation of the prevascularized Cell Pouch (TM) demonstrated biocompatibility and safety of the Cell Pouch as well as viability and vascularization of its transplanted insulin-producing islets, a first in world achievement in a prevascularized implantable medical device.
“This first-in-human work helped frame the design of Sernova’s new Phase I/II clinical protocol. Our clinical team at the University of Chicago is excited to initiate this trial of Sernova’s transformative technology,” said principal investigator, Dr. Piotr Witkowski, M.D., Ph.D.
“To support the clinical study’s timely execution under the highest quality standards, Sernova and CTI (Clinical Trial and Consulting), a well-respected clinical research organization with deep experience in the regenerative medicine field, are working closely with Dr. Witkowski’s team,” said Dr. Philip Toleikis, Sernova’s President and CEO.
The study is a Phase I/II, non-randomized, open label, single-arm, company-sponsored trial. Under the clinical leadership of Dr. Witkowski, University of Chicago Medicine, subjects with hypoglycemia unawareness enrolled in the study under informed consent will be implanted with the Cell Pouch. 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.
A sentinel pouch, also transplanted with islets, will be removed for an early assessment of the islet transplant. Subjects will be 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. Subjects will then be further followed for one year, with interim participants results released at periodic intervals consistent with an open-label study.
About Sernova’s Cell Pouch Technologies
The Cell Pouch is a novel, proprietary, scalable, implantable prevascularized macroencapsulation device for the long-term survival and function of therapeutic cells (donor, stem cell derived cells and xenogeneic cells) which then release proteins and/or hormones as required to treat disease. The device is designed to eliminate concerns of fibrosis upon implantation by incorporating with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells. The device 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.
Type1 Diabetes (T1D) is a life-threatening disease in which the body's immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose. The existing standard of care for patients with TID is suboptimal. To date, there is no cure for T1D, and people living with the disease are dependent on exogenous insulin therapy to help keep their blood-sugar levels from spiking too high, which can lead to long-term complications such as kidney and heart diseases or an acute, potentially deadly health crisis. Present-day insulin therapy is, however, an imperfect treatment method that requires people with T1D to carefully monitor their blood sugar throughout the day and take multiple, calculated doses of insulin based on food intake, exercise, stress, illness and other factors. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with T1D achieve their long-term blood glucose targets, placing them at risk for T1D- related health complications.
About Sernova Corp
Sernova Corp is developing regenerative medicine therapeutic technologies using an implantable medical device 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 Philip.email@example.com www.sernova.com
Ray Matthews & Associates Tel: (604) 818-7778 firstname.lastname@example.org www.raymatthews.ca
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 planned US 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.