Press Release - June 06, 2011
Sernova Corp Presents Key Data at International Transplant Conference
COMPANY'S PRESENTATION SUMMARIZES
ISLET SPARING RESULTS USING ITS CELL
SYSTEM(tm) IN AN ALLOGRAFT ISLET
Source: Sernova Corp
LONDON, ONTARIO (Marketwire - June 6, 2011) - Sernova Corp (TSX VENTURE:SVA) is pleased to report positive results from a key study demonstrating the islet sparing capacity of the Cell Pouch System(tm) implanted with donor islets (allograft) in a model of diabetes.
Dr. Philip Toleikis, Sernova's President & CEO stated, "These data confirm that our Cell Pouch System(tm) provides an excellent safety and efficacy profile using a minimal dose of islets and an antirejection drug regimen to prevent rejection of the islets in the graft."
Sernova Corp was invited to deliver a podium presentation to leading diabetologists, pancreas and islet transplant clinicians and scientists this past weekend at the 13th World Congress of the International Pancreas and Islet Transplant Association Conference (IPITA), Prague, Czech Republic held June 1-4th in a presentation entitled, "Islet Sparing Potential of a Subcutaneous Cell Pouch(tm) for Allogeneic Islet Transplantation."
Important findings reported by Sernova include: Glucose control was achieved using the Cell Pouch System(tm) at the lowest dose of islets transplanted, about 25% of the islets typically used in other international clinical islet transplantation programs. . Islet transplanted animals were C-peptide positive, a gold standard measure of islet released insulin glucose control. Presence of insulin in the islets within the Cell Pouch System(tm) was confirmed by insulin staining. Treated diabetic animals maintained good health including stable body weight confirming the effectiveness of the Cell Pouch System(tm) transplant. No adverse events related to the Cell Pouch System(tm) occurred during the study. "This represents another significant preclinical safety and efficacy study of the Cell Pouch System(tm). We have now also confirmed in four controlled pre-clinical studies the robust tissue and microvessel development suitable for therapeutic cell transplant," stated Dr. Philip Toleikis, President and CEO of Sernova Corp.
"Sernova has strong evidence that the Cell Pouch System(tm) as a platform technology is efficacious for autograft (self-tissue) transplants and could potentially be used to restore glucose control in chronic pancreatitis patients and for allograft (donor tissue) transplants for established diabetics administered an antirejection regimen. These consistent findings in multiple studies strongly support the advancement of the assessment of the Cell Pouch System(tm) into human clinical studies," stated Toleikis.
About the Study
The Cell Pouch System(tm) was implanted in adult Gottingen minipigs which were then made diabetic through a dose of streptozotocin. Animals were given Sirolimus and cyclosporine beginning several days prior to implantation of donor islets (Allograft) isolated from the pancreas of Yorkshire Landrace adult pigs. Standard measures of efficacy including fasting and non- fasting glucose levels, glucose tolerance tests (IVGTT), and C- peptide were taken up to the end of the study post- transplant. At the end of the study period, the devices containing the islets were removed and the animals returned to a diabetic state.
Following transplantation, within the low dose islet transplantation group, study animals maintained glucose levels within the normal range, showed glucose tolerance tests (IVGTT) similar to non-diabetic animals and were C- peptide positive, an important confirmation of insulin- producing islet function. Microscopic fluorescence analysis of the devices revealed robust insulin staining associated with islets.
Upon removal of the Cell Pouch System(tm) containing islets, fasting glucose levels returned to the diabetic range and animals required daily insulin injections to maintain normal glucose levels. The animals' return to the diabetic state was further confirmed by IVGTT and C- peptide analysis.
From a safety perspective, no adverse events occurred related to the Cell Pouch(tm) throughout the study following implantation. The devices were well- incorporated with tissue matrix and yet were not visible under the skin, an important consideration for patients.
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, and other chronic debilitating diseases. Based on these encouraging results, the Company is taking steps towards clinical evaluation of its Cell Pouch System(tm). 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).
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.
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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