Trial set to advance given positive results in first patient; more results expected in 2H19
The company had first released results on the Cell Pouch’s safety, tolerability, and efficacy in patients with type 1 and severe hypoglycemia unawareness at the World Congress of the International Pancreas and Islet Transplant Association earlier this month. One patient who received the Cell Pouch met targets for glucose-stimulated blood level C-peptide secretions, insulin, and glucose control 90-days post-transplant. Importantly, no adverse events were reported and the Cell Pouch was well-incorporated into vascularized tissue, leading to successful transplantation of purified islets.
Additional results from this first patient tested revealed an 85.7% reduction in hypoglycemic events from baseline, weight loss of 6.4 kg, and improved glycemic control as measured by CGM. Further results from the study are expected in the second half of 2019, with completion expected by 2021.
As a reminder, the Cell Pouch is an implantable microencapsulation system that provides a vascularized environment for donor islet cells or stem cells. The system is meant to form an “ideal environment” for islet transplantation and is a potential long-term therapy option for type 1 diabetes. Last July, Sernova received a vote of confidence from JDRF for its technology with $2.5 million in funding.
This trial’s progression further solidifies Sernova’s position as one of the advanced players in the type 1 competitive landscape. ViaCyte’s phase 1/2 PEC-Encap/VC-01 and PEC-Direct/VC-O2 are the only other beta cell encapsulation candidates to reach the clinical development stage, while Semma Therapeutics has just revealed proof-of-concept for their MAILPAN system. See more in our competitive landscape.
--by Ursula Biba, Martin Kurian, and Kelly Close