Press release Communiqué de presse
Press release Communiqué de presse
July 12, 2010 12 July, 2010
Sernova Announces Positive Results of its Proprietary Cell Pouch System(tm) in Preclinical Diabetes Model
Source: Sernova Corp
July 12, 2010, 6:00 a.m. EDT
LONDON, ONTARIO--(Marketwire -- July 12, 2010) - Sernova Corp. (TSX VENTURE:SVA) is pleased to report positive results from a long-term study evaluating the safety and efficacy of the Cell Pouch System(TM) in a pre- clinical model of diabetes.
Detailed data will be presented at the 23rd International Conference of the Transplant Society, Vancouver, British Columbia, Canada, August 15th-19th in a presentation entitled, "A novel Cell Pouch(TM), an alternative to intrahepatic islet transplantation."
Dr. Philip Toleikis, Sernova's President & CEO, noted "Our Cell Pouch System(TM) is a proprietary medical device implanted under the skin rapidly forming into a tissue- engineered, organ-like structure that provides a natural environment for the survival and function of therapeutic cells. These long-term results represent a significant achievement as a possible alternative to the current practice of injecting islets directly into the portal vein of the liver."
"Our data are profound because they suggest the potential to reduce side-effects associated with the current standard of care and achieve glucose control with significantly fewer islets than normally required," said Toleikis.
On March 16, 2010, Sernova reported initial results demonstrating that the Cell Pouch System(TM) becomes rapidly vascularised and achieved initial glucose control in subject animals.
The following summarizes important new findings reported today: Long-term insulin independence was successfully achieved with significantly fewer islets than the current standard of care, requiring only about 10% of insulin- producing islets normally used for the Edmonton Protocol. Animals in the study achieved long-term glucose normalization throughout the course of the study. Standard laboratory tests demonstrated transplanted islets produced insulin and responded similarly to non- diabetic animals to provide control of glucose. No adverse events related to the Cell Pouch System(TM) occurred during the study. About the Study
The Cell Pouch System(TM) was implanted in pigs which were then made diabetic through removing the pancreas and chemical induction. The animal's own islets (Autograft) isolated from the pancreas were transplanted into the device. Standard measures of efficacy including fasting and non-fasting glucose levels, glucose tolerance tests (IVGTT), and C-peptide were taken up to 72 days post- transplant. At the end of the study period, the device containing the islets was removed and the animals returned to a diabetic state.
Following transplantation, a substantial number of 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 device revealed both microvessels and insulin 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 of over 40 devices for up to 5 months. The devices were well-incorporated with collagen at all time points and yet were not visible under the skin, an important consideration for patients.
Dr. David White, Chair of Sernova's Scientific Advisory Board stated, "I am particularly enthusiastic about these results and the potential clinical relevance to patients suffering from diabetes. These new data suggest that the Cell Pouch System(TM) represent a possible clinically relevant alternative to injection of islets into the portal vein of the liver and may reduce the side effects of transplantation including the instant blood- mediated reaction (IBMR). The indication that our device achieves glucose control with a reduction in the number of islets normally required is also of profound clinical importance as it may increase the availability of life-changing islet transplantation to many diabetic patients."
Sernova believes that 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).
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.
The securities offered have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or any applicable exemption from the registration requirement of such Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
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.