Mr. Dominic Gray reports
SERNOVA'S PRINCIPAL INVESTIGATOR TO PRESENT INTERIM DATA FROM THE COMPANY'S ONGOING PHASE I/II CELL POUCH CLINICAL TRIAL AT THE 17TH WORLD CONGRESS OF THE INTERNATIONAL PANCREAS AND ISLET TRANSPLANT ASSOCIATION
Dr. Piotr Witkowski, director of pancreatic and islet transplant program at the University of Chicago, will present, in an oral podium session, early preliminary data and observations from Sernova Corp.'s continuing clinical trial, entitled A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch for Clinical Islet Transplantation, at the 17th World Congress of the International Pancreas and Islet Transplantation Association (IPITA) which is being held July 2 to July 5, 2019, in Lyon, France.
Dr. Witkowski is scheduled to deliver his address during a symposium on islet transplantation on July 3, 2019, at 10:45 a.m. Central European Time at Lyon's Catholic University in the Amphitheater Merieux 1 & 2. Further details on the scientific program can be found on the conference website.
The International Pancreas and Islet Transplantation Association aims to serve the pancreas and islet transplant scientific community in providing a forum for the open exchange of knowledge and expertise in order to facilitate the advancement of the clinical practice of pancreas and islet transplantation for the treatment of human diabetes.
About Sernova's clinical trail
Sernova is conducting a phase I/II non-randomized, unblinded, single-arm, company-sponsored trial to assess the safety and tolerability of islet transplantation into the company's patented Cell Pouch in diabetic subjects with hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of defined measures.
Eligible subjects are implanted with Cell Pouches. Following development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets, under strict release criteria, transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regard to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will be then further followed for one year to assess longer-term safety and efficacy.
About Sernova Corp.
Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell-derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.
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