IRB Approval Signals ‘Green Light’ for Sernova’s Clinical Protocol to Proceed
LONDON, Ontario, May 14, 2018 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE:PSH), announces today it has received University of Chicago Institutional Review Board (IRB) approval to begin a new clinical protocol for the FDA-cleared human clinical trial to investigate the Cell Pouch™ for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia unawareness.
The University of Chicago Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research is conducted in accordance with all federal, institutional, and ethical guidelines. The primary goal of an IRB is to safeguard the rights, safety and welfare of participants in research studies.
"The approval of our clinical protocol by the University of Chicago IRB represents a significant milestone enabling the company to expand the clinical testing of our Cell Pouch System to the US. Patient selection and enrollment can now proceed," said Dr. Philip Toleikis, Sernova President and CEO.
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness will be enrolled into the study under informed consent. Subjects will then be implanted with Cell Pouches. Following development of vascularized tissue chambers within the Cell Pouch, subjects will then be stabilized on immunosuppression and a 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. 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.
About Sernova’s Cell Pouch™ Technologies
The Cell Pouch™ is a novel, proprietary, scalable, implantable macroencapsulation device designed to prevent device fibrosis 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 upon implantation to incorporate 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
T1D is a life-threatening disease, affecting more than 3.3 million individuals in Canada and US, 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 disruptive regenerative medical technologies using a 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. For more information, please visit www.sernova.com
For further information contact:
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 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.