Sernova’s Clinical Trial Supported With Continuous Glucose Monitoring Systems

Sernova Corp. recently announced continuous glucose monitoring systems [CGM (Medtronic Minimed, Northridge, CA)] will be provided to patients in Sernova’s US regenerative medicine clinical trial of its Cell Pouch. CGM will be used to track the function of the transplanted cells in the measurement of key efficacy measures at multiple time points following transplantation of the therapeutic cells into the Cell Pouch.

Glucose variability and hypoglycemia duration can be determined using CGM. CGM involves the subcutaneous placement of a glucose sensor connected to a pager-sized monitoring device that stores glucose data over a 6-day period. Data from each period will be analyzed for mean glucose concentration, mean glucose variability, number and duration of hyper- and hypo- glycemic episodes, and total duration of hypoglycemia.

“We believe continuous glucose monitoring of patients may be an important and sensitive method to closely track the function of the transplanted therapeutic cells within the Cell Pouch,” said Dr. Philip Toleikis, Sernova’s President and CEO. “We are pleased with our collaborators in this study who have shown the foresight to support type 1 diabetes patients seeking treatment via next-generation regenerative medicine technologies.”

Sernova has recently received US FDA notice of allowance for its IND for a new human clinical trial with the Cell Pouch System (CPS) in the US. Sernova is taking final steps to begin enrollment of patients in the new clinical trial under this US IND to investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia unawareness. The trial is a Phase I/II prospective single arm study of islets transplanted into the subcutaneously implanted Cell Pouch. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to assess efficacy through a series of defined measures.

The study is a Phase I/II single site, single arm, Company sponsored trial. Following approval by the Institutional Review Board, patients with hypoglycemia unawareness will be enrolled into the study under informed consent. Patients will then be implanted with the Cell Pouch including sentinel devices. Following vascularized tissue development, a 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 whether to transplant a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year. CGM is planned to provide a sensitive and accurate tracking method to follow important efficacy measures at various time points throughout the study.

The Cell Pouch is a novel, proprietary, scalable, implantable 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 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 with diabetes and has been proven to provide a biologically compatible environment for insulin producing cells in humans.

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.

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 treated through replacement of proteins or hormones missing or in short supply within the body. For more information, visit www.sernova.com.