Press Release - October 25, 2011
Sernova Enters Into Collaboration With Edmonton'S Clinical Islet Transplant Program To Expand Cell Pouch(tm) Applications For Diabetes Treatment
Source: Sernova Corp
LONDON, ONTARIO - (Marketwire - October 25, 2011) - Sernova Corp. (TSX-V: SVA), is pleased to announce it has entered into a collaboration with The Clinical Islet Transplant Program at the University of Alberta Hospital.
The Program is headed by Dr. James Shapiro, MD, Ph.D. FRCS (Eng) FRCSC, the leader of the team that developed the Edmonton Protocol, the current standard of care for islet transplantation. In September 2010, following review of Sernova's preclinical data, Dr. Shapiro joined the Corporation's Scientific Advisory Board.
"Dr. Shapiro's contributions to date position us to enter into this important collaboration which is targeted to expand access to islet transplantation for the treatment of diabetes to a much wider base of patients using Sernova's Cell Pouch(tm)," said Dr. Philip Toleikis, Ph.D., President and CEO of Sernova.
The current procedure for islet transplantation to treat diabetes, commonly known as the "Edmonton Protocol" involves transplanting islets directly into a blood vessel (portal vein) of the liver. The Cell Pouch(tm) is expected to solve a number of issues arising from portal vein delivery. For example, the Cell Pouch(tm) provides a natural setting where blood vessels grow adjacent to the islets rather than being bathed in blood which can result in the death of up to 75% of the islets through an instant blood mediated inflammatory response (IBMIR). Use of the Cell Pouch(tm) would eliminate portal vein hypertension and thrombosis associated with portal vein islet delivery and potentially reduce the cost of the procedure as the catheterization laboratory is not required for implantation of the Cell Pouch(tm) or islet transplantation. Importantly, preclinical studies of the Cell Pouch(tm) have consistently shown excellent safety and efficacy profiles with significantly fewer islets than for portal vein delivery, which could increase the number of recipients treated with the current donor pool. Furthermore, implantation of the Cell Pouch(tm) just under the skin allows for imaging of the islets and microvessels and for local immunoprotection of therapeutic cells.
Sernova's Cell Pouch(tm) is a scalable medical device providing a natural "organ-like" environment for therapeutic cells. Once implanted under the skin, the Cell Pouch(tm) develops pancreas-like function when infused with islets, controlling blood sugar levels as shown by published preclinical data which also suggests that the natural environment promotes cell survival reducing the number of islets required for therapy.
Sernova is currently pursuing upcoming human testing of the Cell Pouch(tm) based on the strong preclinical safety and efficacy data generated to date.
This collaboration will further seek to position the Cell Pouch(tm) through next generation improvements to the Edmonton Protocol to expand access to cell transplant to a much wider patient population. The collaboration will include work related to: Assessment of islet protective agents that could further reduce the islet mass required for each transplant using the Cell Pouch(tm)
Assessment of locally administered anti-rejection strategies within the Cell Pouch(tm) with the goal of reducing or eliminating systemic antirejection regimens
Assessment of a proprietary, ethically derived insulin- producing stem cell technology within the Cell Pouch(tm) as an enabling technology which could significantly expand the number of patients treated
Development of high resolution imaging systems to enable physicians to better assess and optimize long- term islet function A video describing the Edmonton Protocol and the collaboration of Sernova with Dr. Shapiro may be viewed on Sernova's website at www.sernova.com
"The safety and efficacy of the Cell Pouch(tm) in preclinical studies is impressive. We are excited to be working with Sernova in both preparing for its upcoming clinical trial and in this collaboration. We are hopeful that Sernova's Cell Pouch(tm) will significantly increase the number of diabetic patients that can be treated with islet transplantation," said Dr. Shapiro, Director of the Clinical Islet Transplant Program, at the University of Alberta and member of Sernova's Scientific Advisory Board.
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.
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