Sernova Announces Interim Results From Key Preclincal Study With Its Proprietary Cell Pouch SystemTM

Main Category: Clinical Trials / Drug Trials
Also Included In: Diabetes;  Medical Devices / Diagnostics
Article Date: 16 Mar 2010 - 16:00 PDT


Sernova Corp. (TSX VENTURE:SVA) today reported interim results from a key porcine diabetes study evaluating the safety and efficacy of the Cell Pouch System™.

Interim results, to be presented at the American Society of Artificial Internal Organs 56th Annual Conference, Baltimore, MD, May 27th-29th in a podium presentation, confirm that the Cell Pouch System™ establishes a biological environment capable of preserving the functionality of therapeutic cells. The results also confirm the Cell Pouch System™ allows for safe and efficacious cell-based therapy and may offer a revolutionary improvement over the current practice of injecting therapeutic cells into blood vessels.

The Cell Pouch System™ is a proprietary medical device, implanted below the skin, allowing for incorporation of tissue and microvasculature to form an organ-like structure, establishing an environment for the survival and functionality of therapeutic cells.

The study supported by a $486,000 financial contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) involves implantation of Sernova's novel medical device into diabetic pigs to establish device parameters and optimize performance.

Dr. Philip Toleikis, Sernova's President & CEO stated, "These promising interim results are being used to finalize the device design and manufacture for the pivotal pre-clinical studies required by the FDA, in support of a future Phase I/II human clinical study."

In this study Sernova's proprietary Cell Pouch System™ was implanted under the skin of eight week old Yorkshire-Landrace pigs and evaluated for tissue incorporation and microvasculature development for various time periods up to eight weeks. Animals were then made diabetic using a stringent method with a combination of pancreatectomy and streptozotocin. The animal's own islets (Autograft) were isolated from the pancreas and following functional assessment, transplanted into the chambers of the Cell Pouch™. At intervals, various efficacy measures including fasting and non-fasting glucose levels were recorded as well as glucose tolerance tests (IVGTT) performed. After up to three months following islet transplantation, pouches were removed and efficacy measures repeated.

From an efficacy perspective, all transplant recipients showed graft function demonstrated by a reduction in blood glucose and glycemic control (IVGTT and glucose area under curve (AUC) measures). Following removal of the transplanted Cell Pouch™ up to the three month time point there was a significant reduction in glucose disappearance rate and glucose AUC indicating a loss of graft function. Importantly, functionality was achieved using 5% - 10% of the equivalent number of functional adult islets normally transplanted using the Edmonton Protocol procedure.

From a safety perspective, no adverse events occurred related to the Cell Pouch™ throughout the study following implantation of the device. The devices were well-incorporated with collagen at all time points and yet were not visible under the skin, an important consideration for patients. Quantitative blinded analysis of blood vessel growth showed significant microvasculature development in the pouches at all time points assessed. Specific differences between the device configurations will enable selection of the final device design.

"These interim results represent a significant achievement of the Cell Pouch System™ as a possible clinically relevant viable alternative to injection of islets into the portal vein of the liver and may reduce the side effects of such transplantation such as the instant blood-mediated reaction (IBMR)," said Dr. David White, Chair of Sernova's Scientific Advisory Board. "The potential that our device may also achieve functionality with a reduction in the number of islets normally required is also of profound clinical importance."

Sernova believes that the Cell Pouch System™ has the potential for a wide range of uses in cell therapy including the treatment of diabetes, haemophilia, spinal cord injury, Parkinson's disease and other chronic debilitating diseases.

According to the American Diabetes Association approximately 9 million Americans require insulin injections and it is the sixth leading cause of death in the United States. One out of every eight dollars spent on health care in the United States is spent on treating diabetes and its complications. Worldwide expenditures on insulin alone are estimated to be $15 billion annually and growing.

Source
Sernova Corp.

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