World First: Islet Transplant Into Man Using Sernova's Cell Pouch(TM) for Treatment of Diabetes
Sernova Corp. ("Sernova" or the "Company") (TSX VENTURE: SVA) and the University of Alberta today announced the treatment of the first patient with insulin-producing islets transplanted into Sernova's Cell Pouch in a Phase I/II clinical study to treat Type-1 diabetes led by Dr. James Shapiro, Professor of Surgery and Medicine, University of Alberta and Director, Clinical Islet Transplant Program. Sernova will host a conference call at 9 a.m. EDT, today, Aug. 16, 2012, to discuss the company's clinical and business developments.
"The Sernova Cell Pouch implantation and transplantation processes are simple, rapid minimally invasive procedures, conducted on an outpatient basis under local anesthesia," said Dr. Shapiro. "This offers substantial potential benefit over the Edmonton protocol and the ease of use provides an opportunity for the Cell Pouch to become the standard of care for people with diabetes if it proves to be effective in these initial trials."
The objectives of the human clinical trial are to assess the safety and efficacy of the Cell Pouch with transplanted islets in up to 20 patients with Type-1 diabetes. The study is sponsored by Sernova Corp and the University of Alberta. In the study, patients who have met the enrolment criteria and provided informed consent are implanted with the Cell Pouch prior to transplantation of donor human islets. To prevent islet graft rejection, patients in this study are treated with the best in class standard of care immunosuppression protocol. Interim analysis of the data from this clinical study is expected during H1, 2013. Further information on the trial may be found at www.clinicaltrials.gov (Identifier: NCT01652911).
"The Cell Pouch is a breakthrough technology which has the potential to significantly improve the lives of people living with chronic diseases such as diabetes," said Philip Toleikis, Ph.D., President and CEO of Sernova Corp. "Supported by Sernova's strong preclinical results, the treatment of patients in this clinical trial of the Cell Pouch further advances our vision for the future of providing millions of diabetic patients with the Cell Pouch, and an unlimited source of insulin-producing cells protected with a local anti-rejection technology."
The conference call to discuss Sernova's clinical and business developments may be accessed by dialing 866-532-1852 for domestic callers and +443-842-7644 for international callers. Please specify to the operator that you would like to join the "Sernova conference call" or "conference ID: 21155379."
About The Cell Pouch
The Cell Pouch is a proprietary medical device that, following subcutaneous implantation, incorporates with tissue and microvessels forming a natural environment for transplantation of therapeutic cells. Multiple preclinical studies demonstrated the Cell Pouch to provide a safe environment for transplantation, as well as long-term efficacy of therapeutic cells. Sernova's goals for the Cell Pouch for diabetes include providing a safe and natural site for islets to significantly increase the number of patients currently treated with intraportal delivery of donor islets and to provide a safe environment for virtually unlimited available sources of insulin-secreting cells such as insulin-producing stem cells and xenogeneic cells. This vision combined with local anti-rejection protection of the cells could enable millions of patients with insulin-dependent diabetes to be treated without limitation to availability of cells.
Sernova Corp. is a clinical stage health-sciences company focused on commercializing medical technologies. Sernova is currently developing a platform technology for a number of serious disease indications, starting with a novel treatment for insulin-dependent diabetes, using the novel Cell Pouch System for transplantation and long-term survival of therapeutic cells and its patented Sertolin cell technology which can provide an immune-protected local environment for therapeutic cells.
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Contacts: Sernova Corp. Philip Toleikis, Ph.D. President and CEO (604) 961-2939