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2018-12-20 16:18 ET - News Release Dr. Philip Toleikis reports SERNOVA ANNOUNCES ENROLLMENT OF FIRST PATIENT IN U.S. PHASE I/II STUDY OF CELL POUCH FOR TREATMENT IN TYPE 1 DIABETES Sernova Corp. has enrolled the first patient in a phase 1/2 trial of its Cell Pouch for clinical islet transplantation in Type 1 diabetes. "There is a real need for new treatment options in the field of Type 1 diabetes," commented Dr. Piotr Witkowski, principal investigator as well as director of the pancreatic and islet transplant program at the University of Chicago School of Medicine. "Due to Sernova's novel approach to demonstrate vascularization of the Cell Pouch, and remarkable preclinical and first-in-human data, we are hopeful this study will provide a new functional therapeutic option in the treatment of patients with diabetes. We expect completion of enrolment of the first patient cohort to be January, 2019, and full enrolment to be completed by mid-2019 as we continue to screen patients for the Sernova study." "The initiation of this phase 1/2 trial is an important milestone for Sernova, as our team looks to showcase our research and development efforts in diabetes on a clinical level at the University of Chicago, a world leader in regenerative medicine," commented Dr. Philip Toleikis, president and chief executive officer of Sernova. "In our pilot first-in-human study, Sernova's regenerative medicine approach, involving therapeutic cells within Sernova's Cell Pouch, showed surviving vascularized islets able to produce all the hormones necessary to control blood glucose levels. Based on these positive initial results, we expect our therapeutic approach will demonstrate continued safety and therapeutic benefit to people suffering from Type 1 diabetes." The company is expecting to report preliminary safety data from Sernova's clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019. About the study The approved protocol is a phase 1/2 non-randomized, unblinded, single-arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. Participants are then implanted with Cell Pouches. Following the 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, is transplanted into the Cell Pouch. A sentinel pouch will be removed for an early assessment of the islet transplant. Subjects will be 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 then be further followed for one year. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures. About diabetes Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. To date, there is no cure for Type 1 diabetes. People living with the disease are dependent on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats. Only one-third of people with Type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for Type 1 diabetes-related health complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop in blood sugar without warning symptoms, represents more than 15 per cent of the Type 1 diabetes population. About Cell Pouch The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device designed for the long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat disease. The device, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes, and has been proven to provide a biologically compatible environment for insulin-producing cells in humans. About Sernova Corp. Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic 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. Quelle: www.stockwatch.com |
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| aus der Diskussion: | Sernova – Patentierte Zelltaschen mit Schutzschild gegen die Immunabwehr ! |
| Autor (Datum des Eintrages): | techinvestor69 (21.12.18 08:29:51) |
| Beitrag: | 399 von 8,457 (ID:59486820) |
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