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Sernova Biotherapeutics Provides Positive Interim Data from Ongoing Phase 1/2 Clinical Trial of Cell Pouch Bio-hybrid Organ in Patients Living with Type 1 Diabetes
Clinical Study on Track to Meet its Primary and Secondary Endpoints Data Demonstrate That...
About this update from Sernova Biotherapeutics Inc
[{"type":"text","content":"Sernova Biotherapeutics Provides Positive Interim Data from Ongoing Phase 1/2 Clinical Trial of Cell Pouch Bio-hybrid Organ in Patients Living with Type 1 Diabetes\n\n\n\n\n Clinical Study on Track to Meet its Primary and Secondary Endpoints\n \n\n\n\n Data Demonstrate That Metabolic Measures Improve with Cumulative Quantities of Transplanted Donor Islets\n \n\n\n\n Data Demonstrate Islet Engraftment in Cell Pouch and Islet Functionality, Including C-Peptide Production\n \n\n\n\n All Patients Reached or Maintained the ADA Recommended HbA1c of <7.0%\n \n\n\n\n Patient Reported Data Show an Improved Awareness of Onset of Hypoglycemia, a Reduction of Fear of Hypoglycemic Events and a Reduction in Distress Associated with Managing Their Type 1 Diabetes\n \n\n\n LONDON, Ontario and BOSTON, May 14, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing its Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today announced positive interim data from its ongoing Phase 1/2 clinical trial in patients with T1D.\n \n\n Interim data from 12 patients with transplanted human donor islet cells in Cohort A and ongoing Cohort B show patients achieving insulin independence, islet cell engraftment in Cell Pouch, islet function, islet survival, improved glycemic control, improved patient reported quality of life (QOL) and improved awareness of hypoglycemia and increased sensitivity to severe hypoglycemic symptoms. Improvement in patient outcomes was correlated with a cumulative increase in the quantity of transplanted islets. Based on these findings, the study is on track to meet its primary and secondary endpoints, and the confirmatory Cohort C is expected to initiate in H2 2025.\n \n\n Clinical trials with iPSC islet-like clusters from Sernova’s partner, Evotec, are anticipated to begin in 2026 after completion of Cohort C of the ongoing trial. These interim findings, with 8 of 12 patients achieving insulin independence so far, support the thesis that Sernova’s high volume ten channel Cell Pouch, used in Cohort B, plus an optimised immune suppression regimen, has the potential to achieve insulin independence, without portal vein transplant, in our planned clinical trial with Evotec’s high quality iPS...