Memorandum

Sernova announces positive preliminary results for Cell Pouch system in type 1 diabetes – July 22, 2019

Trial set to advance given positive results in first patient; more results expected in 2H19

Sernova announced this past week that its phase 1/2 trial for the Cell Pouch beta cell encapsulation system will advance given positive preliminary safety and efficacy results.

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.

 

 

--by Ursula Biba, Martin Kurian, and Kelly Close