Sernova Corp
TSX VENTURE : SVA

Sernova Corp

February 28, 2011 06:00 ET

Sernova Reports Positive Cell Pouch™ Performance in a Non-Human Primate Study

LONDON, ONTARIO--(Marketwire - Feb. 28, 2011) - Sernova Corp. (TSX VENTURE:SVA) today announced positive performance of its proprietary Cell Pouch System™ in a non-human primate study.

As a precursor to planned human trials with the device, the study, conducted in collaboration with the University of Illinois Transplant Biology Research Laboratory, was designed to further investigate the safety profile of Sernova's Cell Pouch System™ and its ability to develop a natural environment for therapeutic cells in the primate. In previous large animal studies, the Cell Pouch System™ was demonstrated to become rapidly vascularized and form a hospitable environment for therapeutic cells.

In the current study, a number of Cell Pouches were implanted under the skin of the Cynomolgus monkey in a minimally invasive procedure mimicking the technique to be used in upcoming human trials.

In Summary:

  • The Cell Pouches were virtually undetectable under the skin following implantation, an important aesthetic characteristic for human use.

  • The safety profile of the Cell Pouch™ was exemplary throughout the eight week study with no skin irritation, no inflammation and no infections. 

  • At the time of removal, the Cell Pouches™ at all assessment time points (2, 4 and 8 weeks) were well-incorporated with collagen and tissue, had well-established blood supplies and formed intra-pouch cavities suitable for therapeutic cell transplantation.

These key features of the Cell Pouch™ are believed to provide for long-term survival of therapeutic cells demonstrated in Sernova's efficacy studies.

"These results in the non-human primate strengthen the potential of the Cell Pouch™ for human clinical trials, supporting previously reported findings of the formation of a natural, safe and efficacious environment for cell implantation in small and large animal models of diabetes," said Dr. Shapiro, Director of the Clinical Islet Transplantation Program at the University of Alberta and member of Sernova's Scientific Advisory Board.

The Cell Pouch System™ is a proprietary medical device which may offer a revolutionary improvement over the current practice of injecting therapeutic cells into blood vessels. Based on previous pre-clinical research, the Cell Pouch System™ becomes a vascularised organ-like endocrine structure when placed in the body, providing the microcirculation thought to be essential to early function and long-term survival of therapeutic cells. Sernova has conducted efficacy studies in small and large animal models of diabetes and shown the device with insulin-producing islets to control blood glucose levels long-term without the need for daily insulin injections. Sernova believes 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 8 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.

About Sernova

Sernova Corp. is a Canadian-based health sciences company focused on product development and commercialization of innovative proprietary platform medical technologies in the cell therapy arena such as the Cell Pouch System™ to provide a safe and efficacious environment for therapeutic cells and Sertolin™, a technology which, when combined with cell therapy, may protect therapeutic cells without the need for patients to take anti-rejection drugs.

This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors - including availability of funds, the results of financing efforts, the results of research and product development activities -- that could cause actual results to differ materially from Sernova's expectations are disclosed in Sernova's documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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