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Sernova Corp. (TSXV: SVA) “CGM” will be provided to patients for a clinical trial of its Cell Pouch™.

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Sernova Corp., a clinical stage company developing regenerative medicine technologies for the treatment of chronic diseases including diabetes and hemophilia, announced that 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™.

Additional Information:

Company: Sernova Corp.
Website: http://www.sernova.com
Stock Symbol: TSXV: SVA
Date Published: Feb 22, 2018
Transcript: Available

Video Transcript:

I’m Samantha Deutscher for Investmentpitch Media

Sernova Corp. a clinical stage company developing regenerative medicine technologies for the treatment of chronic diseases including diabetes and hemophilia, announced that 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™.

Continuous glucose monitoring systems 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, which 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 hypoglycemic episodes, and total duration of hypoglycemia.

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.

Dr. Philip Toleikis Ph.D., President and CEO, stated: “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. 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 Food and Drug Administration (FDA) notice of allowance for its Investigational New Drug or “IND”, for a new human clinical trial with the Cell Pouch System (CPS) in the United States.

The company 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 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.

Type 1 diabetes 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 Type 1 diabetes is suboptimal.

To date, there is no cure for Type 1 diabetes, 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.

The shares are trading at $0.41.

For more information, please visit the company’s website www.sernova.com, contact Philip Toleikis, Ph.D., President and CEO, at 604-961-2939 or email philip.toleikis@sernova.com

Investor relations is handled by Ray Matthews of Ray Matthews & Associates, who can be contacted at 604-818-7788 or email ray@raymatthews.ca

I’m Samantha Deutscher for Investmentpitch Media