World First: Sernova's Cell Pouch(TM) Shown to Provide a SafeEnvironment for Therapeutic Insulin Producing Islets in Humans withType 1 Diabetes
Dr. James Shapiro, Principal Investigator, Presents Encouraging Results at the XIV World Congress of the International Pancreas and Islet Transplantation Association
LONDON, ONTARIO, Sep 26, 2013 (Menafn - Marketwired via COMTEX) --Sernova Corp today announced that Dr. JamesShapiro, principal investigator of the clinical study, presentedencouraging safety and biocompatibility results for the CellPouch(TM) and following islet transplant, proof of islet cellsurvival and the presence of insulin in the first two patients of anup to 20 patient study. The explanted Cell Pouch(TM) also showed noevidence of immune system attack of the islet cells. The results werepresented in a podium session at the XIV World Congress of theInternational Pancreas and Islet Transplantation Association inMonterey, California.
"We are really encouraged by the initial results of thisground-breaking study. The preliminary findings that human isletssurvive under the skin within the Cell Pouch pave the way for ourongoing studies in patients that will now test how effective this newapproach will be," said Dr. James Shapiro. "Importantly, the isletswere shown to be residing within a natural tissue matrix in thedevice, and were nicely integrated with microvessels, and stained forinsulin, glucagon, somatostatin and polypeptide at the 30 day timepoint." Dr. Shapiro further stated, "We will now begin to assess boththe longer-term safety and efficacy of islets placed in the CellPouch in patients with diabetes, and will follow them for up to threeyears. We look forward to presentation of additional results as thestudy progresses."
In this study, patient volunteers with insulin-dependent diabetes andhypoglycemia unawareness who are receiving an islet transplantfollowing informed consent are being implanted with the CellPouch(TM) which is subsequently transplanted with human donor islets.To protect the islets from immune cell attack, the patients are givenan antibody and immunosuppressive medications.
In an initial assessment, the Cell Pouches(TM) in these first twopatients were shown to meet the primary endpoint of being safe afterimplantation and prior to transplantation. The Cell Pouches(TM) werethen transplanted with human donor islets followed by removal up to30 days post-transplantation and islet survival assessed. The CellPouches(TM) were prepared for comprehensive histological analysis andassessed by experts in an independent blinded analysis for keyfeatures including device biocompatibility, tissue and microvesseldevelopment into the device, islet survival and the presence ofinsulin, glucagon, somatostatin, and polypeptide as well asprotection of islets from immune system attack.
"The findings in these initial patients parallel the results inSernova's multiple small and large animal safety and efficacy studiesof the Cell Pouch. These showed an exemplary safety profile, and thatislets were well-vascularised with microvessels and produced insulin.In addition, the islet-rich Cell Pouches then went on to showlong-term glucose control in the diabetic animals," said Dr. DavidWhite, Professor Emeritus and Chair of Sernova's Scientific AdvisoryBoard.
"We see these initial findings, in humans as an important next stepin confirming the utility of the Cell Pouch in the clinical settingas providing a safe environment for therapeutic cells. We lookforward to further results in this study and are excited to continueworking in clinical indications where therapeutic cells can improvethe quality of life for patients not only with diabetes but for thosewith other chronic debilitating diseases," said Philip Toleikis,President and CEO, Sernova Corp.
Sernova is developing the Cell Pouch(TM) as an enabling platform totreat a variety of chronic debilitating diseases including diabetesand hemophilia (in collaboration with Medicyte GmbH) withimmune-protected therapeutic cells and is currently evaluating thesafety and efficacy of the Cell Pouch(TM) in human clinical trialsfor diabetes.
Sernova Corp is a clinical stage company developing medicaltechnologies for the treatment of chronic debilitating metabolicdiseases such as diabetes, blood disorders including hemophilia andother diseases to replace proteins or hormones in short supply withinthe body. Sernova is developing the Cell Pouch(TM), an implantablemedical device which when placed under the skin forms an environmentrich in tissue matrix and microvessels, ideal for placing therapeuticcells which then release proteins and/or hormones as required. Thetherapeutic cells are protected from immune attack by Sernova'sproprietary technology Sertolin(TM) which provides animmune-protected environment for the therapeutic cells.
About the Cell Pouch(TM)
The Cell Pouch(TM) is a proprietary scalable medical device which hasbeen contract manufactured (ISO13485) to meet internationalregulatory standards. It is placed under the skin, and forms an idealenvironment rich in microvessels and tissue matrix for the placementand function of therapeutic cells. The Cell Pouch(TM) is currentlybeing evaluated in clinical trials at the University of Alberta withDr. James Shapiro as principal investigator in patients with Type 1diabetes receiving an islet transplant.
About Sertoli Cells
Sertoli cells when co-localized with donor therapeutic cells releaseprotective factors that can provide a non-toxic, immune-protectedenvironment that may reduce or eliminate the need for dailyanti-rejection drugs that currently must be used by patients withtransplanted tissues and organs. Sernova is currently conductingpreclinical studies to optimize sertoli cells and islets within theCell Pouch(TM) through a NRC-IRAP contribution agreement provided bythe Government of Canada.
About Clinical Islet Transplantation Program
Please view www.islet.ca for more information on the Clinical IsletTransplantation Program at the University of Alberta.
This release may contain forward-looking statements. Forward-lookingstatements are statements that are not historical facts and aregenerally, but not always, identified by the words "expects","plans", "anticipates", "believes", "intends", "estimates","projects", "potential" and similar expressions, or that events orconditions "will", "would", "may", "could" or "should" occur.Although Sernova believes the expectations expressed in suchforward-looking statements are based on reasonable assumptions, suchstatements are not guarantees of future performance and actualresults may differ materially from those in forward lookingstatements. Forward-looking statements are based on the beliefs,estimates and opinions of Sernova's management on the date suchstatements were made. Sernova expressly disclaims any intention orobligation to update or revise any forward-looking statements whetheras a result of new information, future events or otherwise.
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Philip Toleikis, Ph.D.
President and CEO
Russo Partners, LLC
Tony Russo, Ph.D.
Ray Matthews & Associates
SOURCE: Sernova Corp
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