Sernova Receives Health Canada Approval to Initiate Human Clinical Trials of Its Cell Pouch(TM)
FOR: SERNOVA CORP.
MAY 2, 2012 - 06:00 ET
-Patients with insulin-dependent diabetes to be treated with Sernova's subcutaneous Cell Pouch (TM) and insulin-producing islets-
LONDON, ONTARIO--(Marketwire - May 2, 2012) - Sernova Corp. ("Sernova" or the "Company") (TSX VENTURE:SVA) today announced it received Health Canada Approval to conduct a human clinical trial assessing both the safety and efficacy of Sernova's Cell Pouch™ with transplanted insulin-producing islets in patients with insulin-dependent diabetes. The study will be conducted in collaboration with Dr. James Shapiro at the University of Alberta Health Science Centre in Edmonton.
"Sernova's compelling pre-clinical results provide optimism that the Cell Pouch™ has the potential to change the standard of care of patients with diabetes receiving islet transplantation," said Dr. James Shapiro, principal investigator of the study. "I am excited to begin enrolment of patients in this ground breaking clinical study to evaluate the Cell Pouch™ in humans."
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, single-arm, Phase I/II safety and efficacy study of up to 20 patients with insulin-dependent diabetes undergoing allograft pancreatic islet transplantation.
In this study, patients who have met the enrolment criteria and provided informed consent will be implanted with the Cell Pouch™ approximately 2-12 weeks prior to transplantation of donor human islets. To prevent islet graft rejection, patients will be treated with the standard immunosuppressive regimen.
The primary endpoint of the study is to assess the safety of the Sernova Cell Pouch™ in adult participants with Type-1 diabetes receiving islet transplantation for the first time. This endpoint will be assessed just prior to islet transplantation and one month thereafter.
The secondary endpoint of the study is to determine the proportion of subjects implanted with the Cell Pouch™ and transplanted with islets who achieve and maintain insulin independence as measured three months post-final islet transplantation.
In addition, the study will provide preliminary data on the efficacy of the Cell Pouch™ to maintain adequate immunological protection against both allo- and autoimmunity of islet transplant recipients.
Following assessment of primary and secondary endpoints, patients will be followed for a minimum of three years to assess long-term safety and efficacy of the Cell Pouch™. It should also be noted that the study allows for interim analysis of the data at various study time points.
"The initiation of this study marks a significant milestone for Sernova, and 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. We are pleased to have Dr. Shapiro and his team conduct this study at this world class institute for islet transplantation."
The Cell Pouch™ is a proprietary medical device that, once implanted subcutaneously, incorporates with tissue and microvessels. It has been shown in multiple preclinical studies to provide a safe environment for transplantation, as well as 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 for long-term function to enable large numbers 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.
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.
FOR FURTHER INFORMATION PLEASE CONTACT:
Philip Toleikis, Ph.D.
President and CEO
Russo Partners, LLC
Tony Russo, Ph.D.