Press Release - May 05, 2011
Sernova Cell Pouch System™ Demonstrates Islet Sparing Potential In Diabetes Model
DATA TO BE PRESENTED AT THE WORLD
OF THE INTERNATIONAL PANCREAS AND
Source: Sernova Corp
LONDON, ONTARIO--(Marketwire - May 5, 2011) - Sernova Corp. (TSX VENTURE:SVA) is pleased to announce the Company will present preliminary results of its ongoing islet sparing study with its Cell Pouch System(TM), in a late breaking session at the 13th World Congress of IPITA (International Pancreas and Islet Transplant Association), held June 1-4, 2011. Prague, Czech Republic.
This key international conference is held every two years and brings together the worlds eminent scientists and clinicians working to improve the lives of diabetic patients through islet transplantation. Sernova will be making a podium presentation entitled:
"Islet Sparing Potential of a Subcutaneous Cell Pouch(tm) for Allogeneic Islet Transplantation"
In this study, different doses of donor islets were transplanted into the prevascularized Cell Pouch(TM) placed in recipient diabetic animals. Doses ranged from 25% to the full standard of care dose of 10,000 IEQ/kg. Animals were then administered anti-rejection therapy to prevent graft rejection. Efficacy is assessed through standard measures of graft function including glucose tolerance tests, and C-peptide among other measures prior to and after implantation of islets and following Cell Pouch(TM) removal. For example, if a 25% dose were successful, use of the Cell Pouch(TM) could increase the number of transplant recipients by approximately 400% for the current donor pancreas pool.
Dr. James Shapiro, a member of Sernova's Scientific Advisory Board and eminent transplant surgeon at the University of Alberta stated "Positive results from this study would provide further compelling evidence to advance Sernova's Cell Pouch(TM) into human clinical trials. Confirmation of the islet sparing capacity of the Cell Pouch(TM) would be an additional benefit which could eventually allow treatment of more patients using the current donor islet pool."
Under the current standard of care for islet transplant patients, known as the Edmonton Protocol, donor islets are injected directly into the portal vein of the liver. This process is believed to stimulate an instant blood- mediated reaction (IBMIR) which is thought to destroy insulin- producing islets and may lead to further side effects for patients. The Cell Pouch(TM) avoids this reaction because islets are placed in a natural organ-like environment rather than directly into the bloodstream, and could lead to the need for fewer donor islets to achieve efficacy.
The safety and efficacy of the Cell Pouch(TM) has recently been demonstrated in an autograft setting where diabetic animals implanted with the human scaled prevascularized device became insulin independent when their own islets were removed and placed into the Cell Pouch(TM). The study provided efficacy with surprisingly far fewer functional islets than typically required, suggesting the Cell Pouch(TM) may be islet sparing.
The current study is supported in part through a non- repayable financial contribution of up to $275,000 from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP).
The Cell Pouch System(TM) 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(TM) 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(TM) 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.
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(TM) to provide a safe and efficacious environment for therapeutic cells and Sertolin(TM), a technology which, when combined with cell therapy, may protect therapeutic cells without the need for patients to take anti-rejection drugs.
For further information contact: Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939 firstname.lastname@example.org www.sernova.com
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.
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.
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