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LONDON, Ontario and BOSTON, Feb. 03, 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, today announced the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to evaluate the Company’s Cell Pouch auto-transplanted with thyroid cells in patients undergoing total thyroidectomy for nodular thyroid disease.
Hypothyroidism, a condition characterized by insufficient production of thyroid hormones, affects millions of people worldwide, often requiring lifelong daily hormone replacement therapy. Sernova’s Cell Pouch bio-hybrid organ, in combination with autologous thyroid cell therapy, aims to restore natural thyroid function by providing a long-term, stable, and physiological solution for patients suffering from post-operative hypothyroidism, without the need for immune suppression therapy.
“This IND submission represents a step forward in our commitment to transforming endocrine disorder treatment," said Jonathan Rigby, CEO of Sernova. "Our Cell Pouch has shown the ability to establish a vascularized, organ-like environment for transplanted cells, and we believe this innovative approach could restore thyroid function and enhance the quality of life for patients facing lifelong hypothyroidism.”
Data from preclinical trials demonstrated that re-implantation of thyroid tissue into the pre-vascularized Cell Pouch, without immune suppression, resulted in the restoration of the two main thyroid hormones, thyroxine (T4) and triiodothyronine (T3), to pre-thyroidectomy levels, without any hormone supplementation. In addition, radio-isotope uptake imaging and histology assessments confirmed the presence of healthy and functional thyroid tissues within the Cell Pouch five months following re-implantation. Pending FDA clearance, Sernova will explore the initiation of a first-in-human clinical trial to evaluate the safety, tolerability, and efficacy of the Cell Pouch bio-hybrid organ with autologous thyroid cells in patients undergoing thyroidectomy for benign nodular disease.
ABOUT SERNOVA BIOTHERAPEUTICS
Sernova Biotherapeutics is a clinical-stage company developing regenerative medicine therapeutics combining its Cell Pouch with human donor cells or stem cell-derived cell therapies to create bio-hybrid organs to treat chronic diseases. A bio-hybrid organ is comprised of non-biomaterials, such as the Cell Pouch, integrated with living tissues to restore or enhance the function of a compromised organ. This innovative approach aims to deliver a potentially revolutionary treatment for patients with chronic diseases, initially focusing on type 1 diabetes and thyroid disorders.