August 14, 2018
CTI Clinical Trial and Consulting Services (CTI) announces its collaboration with Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH) as Contract Research Organization (CRO) to assist Sernova with the execution of its US Phase I/II clinical trial “Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation.”
“Sernova’s initial interactions with CTI for their US experience of regenerative medicine therapies and clinical and regulatory background were positive in developing an advanced regulatory package submitted to the FDA. The developed synergies led to Sernova receiving FDA clearance for its Investigational New Drug (IND) application. With the excellent working relationship developed between our teams, we have expanded our collaboration in the execution of the clinical trial. This brings us another step closer to our goal, to improve the quality of life and outcomes of people with diabetes,” said Dr. Philip Toleikis, President and CEO of Sernova.
“We see our collaboration with Sernova on this trial in the growing field of regenerative medicine as having the potential to impact many people with diabetes,” said Tim Schroeder, CEO of CTI. “It is a great opportunity for CTI to collaborate with the experienced team at Sernova and allows us to continue our work in cell therapy, currently representing approximately 40% of CTI’s active research programs.”
The study is a Phase I/II, non-randomized, open label, single-arm, company-sponsored trial. Under the clinical leadership of Dr. Witkowski, University of Chicago Medicine, subjects with hypoglycemia unawareness enrolled in the study under informed consent will be implanted with the Cell Pouch. Following vascularized tissue development in the Cell Pouch, an initial dose of purified islets under strict release criteria will be transplanted into the Cell Pouch.
A sentinel pouch, also transplanted with islets, will be removed for an early assessment of the islet transplant. Subjects will be followed for safety and efficacy measures for approximately six months. At this point, a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Subjects will then be further followed for one year, with interim participants results released at periodic intervals consistent with an open-label study.