Press Release - April 22, 2014
Sernova’s Cell Pouch™ Diabetes Clinical Trial Demonstrates Interim Safety and Biocompatibility
Sernova’s Cell Pouch with insulin-producing islets is safe and
biocompatible in patients with unstable diabetes
Source: Sernova Corp FOR RELEASE April 22nd, 2014, 6:00 a.m. EDT LONDON, ONTARIO--(Marketwire – April 22nd, 2014) - Sernova Corp. (TSX-V: SVA), a clinical stage company developing medical technologies for the long-term treatment of chronic metabolic diseases including diabetes, blood disorders such as haemophilia and other diseases, today announced interim results in an ongoing type 1 diabetes human clinical trial with the Company’s Cell Pouch(TM).
Sernova’s human clinical trial is designed to assess the safety and efficacy of the Cell Pouch in subjects with unstable diabetes receiving an islet transplant. Interim study results in the first group of patients support that the implanted Cell Pouch, transplanted with insulin-producing islets is showing longer-term safety and biocompatibility with one of the patients beyond the 180 day time point.
Encouraging early results up to 30 days post-islet transplant were presented at the International Pancreas and Islet Transplantation Congress in September, 2013. These results showed after implantation under the skin, the Cell Pouch is safe and biocompatible. Following islet transplantation, the islets living within a natural tissue matrix were supported with a rich supply of blood vessels, similar to the pancreas. Of further importance, the islets were shown to make insulin, somatostatin and glucagon – key hormones in the control of blood sugar levels. The ongoing study is being conducted with Dr. James Shapiro as principal investigator at the University of Alberta Health Sciences Centre in Edmonton, Alberta.
"The fact that the Cell Pouch continues to exhibit both safety and biocompatibility in longer term follow-up is an important milestone in the early clinical testing of this device, and provides encouragement that human islets transplanted within the device may provide the opportunity to change the standard of care of patients with diabetes," said Dr. James Shapiro. “I look forward to the ongoing results of the investigation as the study progresses."
The study, entitled “A Phase I/II Study of the Safety and Efficacy of Sernova's Cell Pouch for Therapeutic Islet Transplantation,” is an open label, non- randomized, Phase I/II safety and efficacy study of up to 20 patients with type 1 diabetes undergoing allograft pancreatic islet transplantation. Patients who have met the enrolment criteria and provided informed consent are implanted with the Cell Pouch approximately 2-24 weeks prior to transplantation of donor human islets. To prevent islet graft rejection, the standard of care immunosuppressive regimen is provided.
The primary endpoint of the study is to assess the safety of the Sernova Cell Pouch in these patients just prior to islet transplantation, following islet transplantation and at various points during follow up. The secondary endpoint of the study, efficacy, is to determine the proportion of subjects implanted with the Cell Pouch and transplanted with islets who achieve and maintain insulin independence. Patient follow up occurs for a minimum of three years to assess long-term safety and efficacy.
“In the second half of 2014, we expect to provide further preliminary safety and efficacy data”, remarked Dr. James Shapiro.
"This interim update by Dr. Shapiro suggests we are making positive strides forward. The Cell Pouch could potentially be a game changer for patients suffering from this debilitating disease. Indeed, this is the result of years of hard work and dedication from our company's staff and collaborators," said Dr. Philip Toleikis, President and CEO of Sernova Corp. "We have developed the subcutaneous Cell Pouch for Sernova's first clinical application, insulin- dependent diabetes, as an alternative site for islet transplantation that may allow for safer, more efficient engraftment of islets and potential improved long-term insulin independence using a marginal islet mass. What adds further credence to the Cell Pouch’s mechanism of action is the application of the Cell Pouch for other clinical indications which Sernova is undertaking”, added Dr. Toleikis."
About the Cell Pouch The Cell Pouch is a proprietary, scalable, biocompatible medical device, that once implanted subcutaneously, incorporates with the patient’s tissue and microvessels. The Cell Pouch is contract manufactured (ISO13485) to meet international regulatory standards. Sernova’s research has demonstrated that when the Cell Pouch is inserted under the skin, it forms an ideal environment, rich in microvessels and tissue matrix for the placement and function of therapeutic cells. The Cell Pouch 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.
It has been shown in multiple preclinical studies to provide a safe environment for transplantation, as well as for the long-term survival and efficacy of therapeutic cells. Sernova's goals for the diabetes indication include making the Cell Pouch available to a wider group of patients than currently possible with intraportal delivery of islets. Sernova also plans to make the Cell Pouch available as a natural, improved site for non-primary-derived, insulin-secreting cells. This may enable long-term treatment in large numbers of patients with insulin-dependent diabetes without limitation to availability of donor-derived cells.
About Sernova Sernova Corp is a clinical stage regenerative medicine company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including haemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch, an implantable medical device for therapeutic cells (donor, xenogeneic or stem cells) which then release proteins and/or hormones as required.
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 email@example.com www.sernova.com
Ray Matthews & Associates Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6 Tel: (604) 818-7778 www.raymatthews.ca
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.
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