Press Release - September 26, 2013
World First - Sernova's Cell Pouch™ Shown to Provide a Safe Environment for Therapeutic Insulin Producing Islets in Humans with Type 1 Diabetes
Dr. James Shapiro, Principal Investigator, Presents
Encouraging Results at the XIV World Congress of the
International Pancreas and Islet Transplantation
LONDON, ONTARIO (Marketwire — September 26, 2013) - Sernova Corp (TSX-V: SVA), today announced that Dr. James Shapiro, principal investigator of the clinical study presented encouraging safety and biocompatibility results for the Cell Pouch(TM) and following islet transplant, proof of islet cell survival and the presence of insulin in the first two patients of an up to 20 patient study. The explanted Cell Pouch(TM) also showed no evidence of immune system attack of the islet cells. The results were presented in a podium session at the XIV World Congress of the International Pancreas and Islet Transplantation Association in Monterey California.
"We are really encouraged by the initial results of this ground-breaking study. The preliminary findings that human islets survive under the skin within the Cell Pouch pave the way for our ongoing studies in patients that will now test how effective this new approach will be," said Dr. James Shapiro. "Importantly, the islets were shown to be residing within a natural tissue matrix in the device, and were nicely integrated with microvessels, and stained for insulin, glucagon, somatostatin and polypeptide at the 30 day time point." Dr. Shapiro further stated, "We will now begin to assess both the longer-term safety and efficacy of islets placed in the Cell Pouch in patients with diabetes, and will follow them for up to three years. We look forward to presentation of additional results as the study progresses."
In this study, patient volunteers with insulin-dependent diabetes and hypoglycemia unawareness who are receiving an islet transplant following informed consent are being implanted with the Cell Pouch(TM) which is subsequently transplanted with human donor islets. To protect the islets from immune cell attack, the patients are given an antibody and immunosuppressive medications.
In an initial assessment, the Cell Pouches(TM) in these first two patients were shown to meet the primary endpoint of being safe after implantation and prior to transplantation. The Cell Pouches(TM) were then transplanted with human donor islets followed by removal up to 30 days post- transplantation and islet survival assessed. The Cell Pouches(TM) were prepared for comprehensive histological analysis and assessed by experts in an independent blinded analysis for key features including device biocompatibility, tissue and microvessel development into the device, islet survival and the presence of insulin, glucagon, somatostatin, and polypeptide as well as protection of islets from immune system attack.
"The findings in these initial patients parallel the results in Sernova's multiple small and large animal safety and efficacy studies of the Cell Pouch. These showed an exemplary safety profile, and that islets were well- vascularised with microvessels and produced insulin. In addition, the islet-rich Cell Pouches then went on to show long-term glucose control in the diabetic animals," said Dr. David White, Professor Emeritus and Chair of Sernova's Scientific Advisory Board.
"We see these initial findings, in humans as an important next step in confirming the utility of the Cell Pouch in the clinical setting as providing a safe environment for therapeutic cells. We look forward to further results in this study and are excited to continue working in clinical indications where therapeutic cells can improve the quality of life for patients not only with diabetes but for those with other chronic debilitating diseases," said Philip Toleikis, President and CEO, Sernova Corp.
Sernova is developing the Cell Pouch(TM) as an enabling platform to treat a variety of chronic debilitating diseases including diabetes and hemophilia (in collaboration with Medicyte GmbH) with immune-protected therapeutic cells and is currently evaluating the safety and efficacy of the Cell Pouch(TM) in human clinical trials for diabetes.
Sernova Corp is a clinical stage company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases to replace proteins or hormones in short supply within the body. Sernova is developing the Cell Pouch(TM), an implantable medical device which when placed under the skin forms an environment rich in tissue matrix and microvessels, ideal for placing therapeutic cells which then release proteins and/or hormones as required. The therapeutic cells are protected from immune attack by Sernova's proprietary technology Sertolin(TM) which provides an immune-protected environment for the therapeutic cells.
About the Cell Pouch(TM)
The Cell Pouch(TM) is a proprietary scalable medical device which has been contract manufactured (ISO13485) to meet international regulatory standards. It is placed under the skin, and forms an ideal environment rich in microvessels and tissue matrix for the placement and function of therapeutic cells. The Cell Pouch(TM) is currently being evaluated in clinical trials at the University of Alberta with Dr. James Shapiro as principal investigator in patients with Type 1 diabetes receiving an islet transplant.
About Sertoli Cells
Sertoli cells when co-localized with donor therapeutic cells release protective factors that can provide a non-toxic, immune-protected environment that may reduce or eliminate the need for daily anti-rejection drugs that currently must be used by patients with transplanted tissues and organs. Sernova is currently conducting preclinical studies to optimize sertoli cells and islets within the Cell Pouch(TM) through a NRC-IRAP contribution agreement provided by the Government of Canada.
About Clinical Islet Transplantation Program
Please view www.islet@ca for more information on the Clinical Islet Transplantation Program at the University of Alberta.
For further information contact: Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939 firstname.lastname@example.org www.sernova.com
Tony Russo, Ph.D. Russo Partners, LLC Tel: (212) 845-4251 email@example.com
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6 www.raymatthews.ca 604.818.7778
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although Sernova believes the expectations expressed in such forward- looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of Sernova's management on the date such statements were made. Sernova expressly disclaims any intention or obligation 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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