CANADA — Sernova Corp., a clinical-stage company specializing in cell therapeutics, has recently released updated interim data from its ongoing Phase 1/2 clinical trial of the Cell Pouch System, targeting patients with type 1 diabetes (T1D) and severe hypoglycemia unawareness.
The positive results indicate significant progress in the development of this implantable and scalable medical device, designed by Sernova to create a natural environment within the body for the long-term survival and functionality of therapeutic cells.
These cells are capable of releasing essential proteins or factors that are deficient in the body, offering potential treatment options for chronic diseases such as insulin-dependent diabetes.
The Phase 1/2 trial, led by Dr. Piotr Witkowski at The University of Chicago, focuses on evaluating type 1 diabetes patients with severe hypoglycemia unawareness.
The results of this trial were recently presented at the American Diabetes Association’s (ADA) 83rd Scientific Sessions.
Notably, Sernova had previously announced positive data from this trial in June 2022, highlighting three patients who achieved insulin independence.
During the recent presentation, Sernova discussed the initial findings concerning the first 11 patients enrolled in two cohorts of the trial.
The evaluation involved assessing the combination of the Cell Pouch with pancreatic islets, affirming the system’s safety for over four years following implantation.
The function of the transplanted islets was measured using parameters such as blood glucose levels, patient insulin usage, and serum C-peptide.
Dr. Piotr Witkowski expressed optimism about the trial’s outcomes, stating, “I continue to be encouraged by the results achieved in this trial, and especially by the ease of use and favorable response from a single islet transplant to the larger Cell Pouch. I look forward to reporting further data later this year.”
Key findings indicate significant progress in type 1 diabetes treatment
Among the initial six patients in the first cohort who completed the implantation process, including islet transplant to the Cell Pouch and supplemental portal vein islet infusion, five individuals have sustained insulin independence for periods ranging from six months to over three years.
The sixth patient recently completed the protocol-defined islet transplants and is currently awaiting assessment of their islet graft function.
Sernova also reported on a second cohort that utilized the 10-channel Cell Pouch, offering more than 50% greater transplant capacity compared to the previous eight-channel system.
Out of seven eligible patients enrolled in the second cohort, five received their higher-capacity Cell Pouch implants.
Among them, three individuals underwent the first islet transplant to their implanted Cell Pouches. The first evaluable patient in this cohort demonstrated persistent fasting and stimulated serum C-peptide levels.
Sernova further stated that subjects enrolled in the trial have exhibited favorable tolerance to long-term Cell Pouch implantation, indicating a positive safety profile for both types of pouches employed.
Notably, five out of six patients in the first cohort achieved insulin independence following supplemental islet transplants, even when the intraportal islet dose fell below typical levels.
Sernova interprets this as a promising sign, suggesting that the eight-channel Cell Pouch can support ongoing glucose control.
Sernova plans to disclose additional data from the second cohort in the latter half of 2023.
Dr. Philip Toleikis, President and CEO of Sernova, expressed satisfaction with the positive findings, stating, “We are very pleased to see these positive data for our T1D trial with Cell Pouch, and especially our 10-channel Cell Pouch configuration, as we pursue a ‘functional cure’ for patients with T1D.”
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