LONDON - Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-stage company and leader in cell therapeutics, today presented interim positive results from its ongoing Phase 1/2 clinical trial investigating islet allotransplantation into pre- vascularized Sernova Cell Pouch during an oral presentation at the 2023 IPITA, IXA, and CTRMS Joint Congress in San Diego, California.

Enrollment in Cohort A, which utilizes the 8-channel Cell Pouch, is complete with post-transplant data available for periods of follow-up ranging from 6 months to 3.5 years. Enrollment in Cohort B, which utilizes the higher capacity Cell Pouch and a revised and better-tolerated immunosuppressive regimen, began in November 2022 and 6 of the 7 planned patients have now been successfully implanted.

The primary objective of the study is to investigate the safety and tolerability of islet transplantation into Cell Pouch in patients with T1D, impaired hypoglycemia awareness, and a history of severe hypoglycemic episodes. Secondary study objectives include establishment of islet release criteria predictive of outcomes from islet transplant into the Cell Pouch and optimal dose and concentration ranges for purified islets transplanted into the Cell Pouch.

Interim results from Cohort A demonstrated successful implantations of the 8-channel Cell Pouch in the 6 treated patients that were well tolerated with no seromas and no unexpected AEs (adverse events), chronic pain or discomfort. Data showed histological evidence of surviving and functional islets and positive fasting and stimulated serum C-peptide (a measure of islet insulin secretion) in patients who maintained optimal immunosuppression. All 6 patients eventually received supplemental, marginal-dose islet infusions via the portal vein with the first 5 having achieved sustained insulin independence. All 6 Cohort A patients achieved HbA1c values in the non-diabetic range (

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