Sernova Unveils Positive Updated Interim Phase 1/2 Clinical Results for the Cell Pouch System™ at the American Diabetes Association's 83rd Scientific Sessions
Tuesday, June 27, 2023
Sernova Corp., a clinical-stage company specializing in cell therapeutics, has announced positive interim data from its ongoing Phase 1/2 clinical trial of the Cell Pouch System in patients with type 1 diabetes (T1D) and severe hypoglycemia unawareness. The announcement was made during a presentation at the American Diabetes Association (ADA) 83rd Scientific Sessions on June 24th, 2023.
The presentation discussed the preliminary results of the trial, which included eleven patients enrolled in two cohorts. The objective of the trial is to assess the safety and efficacy of the Cell Pouch System in combination with pancreatic islets. The patients' insulin independence and islet function were evaluated based on blood glucose levels, insulin usage, and serum C-peptide levels.
In the first cohort, which comprised six patients, five achieved insulin independence for periods ranging from 6 months to over 3 years. These patients had undergone Cell Pouch implantation, islet transplantation, and supplemental portal vein infusion. The sixth patient in the first cohort recently underwent the islet transplant and is awaiting assessment of graft function.
The second cohort utilized an improved 10-channel Cell Pouch with increased transplant capacity. Out of seven eligible patients, five were enrolled, and three of them received the initial islet transplant to their Cell Pouches. The first evaluable patient in the second cohort showed sustained serum C-peptide levels following a single islet transplant.
Key findings from the interim update include:
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Long-term implantation of the Cell Pouch was well-tolerated and demonstrated a favorable safety profile in both 8-channel and 10-channel configurations.
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Five out of six patients in the first cohort achieved insulin independence, even with lower-than-typical intraportal islet doses. Histological assessment revealed functional islets in five out of six patients.
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The five patients in the first cohort who achieved insulin independence remained free from endogenous insulin therapy for 6 months to over 3 years.
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In the second cohort, five out of seven planned patients were enrolled, and three received the initial islet transplant. One patient demonstrated persistent serum C-peptide levels after a single islet transplant.
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Further data from the second cohort is expected to be available in the second half of 2023.
Dr. Philip Toleikis, President and CEO of Sernova, expressed satisfaction with the positive data and emphasized the company's commitment to pursuing a "functional cure" for T1D patients. Dr. Piotr Witkowski, Director of the Pancreatic and Islet Transplant Program at The University of Chicago and principal investigator of the trial, also expressed optimism and anticipated reporting further data later in the year.
Sernova is collaborating with Evotec SE to advance the Cell Pouch in combination with Evotec's induced pluripotent stem cell (iPSC)-derived islet-like clusters into clinical trials. Additionally, Sernova is working with the University of Miami on conformal coating cellular immune protection technologies to potentially reduce or eliminate the need for immunosuppression agents.
