Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism
Sernova Biotherapeutics (SEOVF) has received FDA clearance for its Investigational New Drug (IND) application to evaluate the Cell Pouch bio-hybrid organ with auto-transplanted thyroid cells in patients undergoing thyroid surgery. The therapy aims to treat hypothyroidism in patients post-thyroid surgery.
The Cell Pouch system, combined with autologous thyroid cell therapy, is designed to restore natural thyroid function without requiring thyroid hormone replacement medications or immune suppression therapy. Preclinical studies have shown successful restoration of primary thyroid hormones (T4 and T3) to pre-thyroidectomy levels when thyroid tissue was re-implanted into the pre-vascularized Cell Pouch. Healthy, functional thyroid tissue was confirmed through radio-isotope imaging and histological analysis up to five months post-implantation.
Sernova Biotherapeutics (SEOVF) ha ricevuto l'approvazione della FDA per la sua richiesta di Nuovo Farmaco Sperimentale (IND) per valutare il sistema Cell Pouch, un organo bio-ibrido con cellule tiroidee auto-trapiantate, in pazienti sottoposti a intervento chirurgico alla tiroide. La terapia mira a trattare l'ipotiroidismo nei pazienti dopo l'intervento chirurgico alla tiroide.
Il sistema Cell Pouch, combinato con la terapia con cellule tiroidee autologhe, è progettato per ripristinare la funzione tiroidea naturale senza la necessità di farmaci sostitutivi degli ormoni tiroidei o di terapie di soppressione immunitaria. Studi preclinici hanno mostrato un ripristino riuscito degli ormoni tiroidei primari (T4 e T3) a livelli pre-tiroidectomia quando il tessuto tiroideo è stato reimpiantato nel Cell Pouch pre-vascolarizzato. Il tessuto tiroideo sano e funzionale è stato confermato attraverso imaging con radioisotopi e analisi istologica fino a cinque mesi dopo l'impianto.
Sernova Biotherapeutics (SEOVF) ha recibido la autorización de la FDA para su solicitud de Nuevo Medicamento en Investigación (IND) para evaluar el sistema Cell Pouch, un órgano bio-híbrido con células tiroideas auto-trasplantadas en pacientes que se someten a cirugía de tiroides. La terapia tiene como objetivo tratar el hipotiroidismo en pacientes después de la cirugía de tiroides.
El sistema Cell Pouch, combinado con la terapia de células tiroideas autólogas, está diseñado para restaurar la función tiroidea natural sin necesidad de medicamentos de reemplazo de hormonas tiroideas o terapia de supresión inmunitaria. Los estudios preclínicos han mostrado una restauración exitosa de las hormonas tiroideas primarias (T4 y T3) a niveles previos a la tiroidectomía cuando el tejido tiroideo fue reimplantado en el Cell Pouch prevascularizado. Se confirmó que el tejido tiroideo sano y funcional a través de imágenes con radioisótopos y análisis histológicos hasta cinco meses después del implante.
Sernova Biotherapeutics (SEOVF)는 갑상선 수술을 받는 환자에게 자가 이식된 갑상선 세포로 Cell Pouch 생체 하이브리드 장기를 평가하기 위한 임상 시험 신약(IND) 신청에 대해 FDA 승인을 받았습니다. 이 요법은 갑상선 수술 후 저하갑상선증을 치료하는 것을 목표로 합니다.
자가 갑상선 세포 요법과 결합된 Cell Pouch 시스템은 갑상선 호르몬 대체 약물이나 면역 억제 요법을 필요로 하지 않고 자연적인 갑상선 기능을 회복하도록 설계되었습니다. 전임상 연구에 따르면, 갑상선 조직이 혈관화된 Cell Pouch에 재이식되었을 때 갑상선 절제술 전 수준으로 주요 갑상선 호르몬(T4 및 T3)의 성공적인 회복이 나타났습니다. 건강하고 기능적인 갑상선 조직은 방사성 동위원소 이미징 및 조직학적 분석을 통해 이식 후 최대 5개월까지 확인되었습니다.
Sernova Biotherapeutics (SEOVF) a reçu l'autorisation de la FDA pour sa demande de Nouveau Médicament Expérimental (IND) afin d'évaluer l'organe bio-hybride Cell Pouch avec des cellules thyroïdiennes auto-implantées chez des patients subissant une chirurgie thyroïdienne. La thérapie vise à traiter l'hypothyroïdie chez les patients après une chirurgie de la thyroïde.
Le système Cell Pouch, associé à une thérapie par cellules thyroïdiennes autologues, est conçu pour restaurer la fonction thyroïdienne naturelle sans nécessiter de médicaments de remplacement des hormones thyroïdiennes ou de thérapies immunosuppressives. Des études précliniques ont montré un rétablissement réussi des hormones thyroïdiennes primaires (T4 et T3) à des niveaux antérieurs à la thyroïdectomie lorsque le tissu thyroïdien a été réimplanté dans le Cell Pouch prévascularisé. Un tissu thyroïdien sain et fonctionnel a été confirmé par imagerie par radio-isotope et analyse histologique jusqu'à cinq mois après l'implantation.
Sernova Biotherapeutics (SEOVF) hat die Genehmigung der FDA für seinen Antrag auf ein Investigational New Drug (IND) erhalten, um das Cell Pouch-Biohybridorgan mit auto-transplantierten Schilddrüsenzellen bei Patienten, die sich einer Schilddrüsenoperation unterziehen, zu evaluieren. Die Therapie zielt darauf ab, Hypothyreose bei Patienten nach der Schilddrüsenoperation zu behandeln.
Das Cell Pouch-System, kombiniert mit der autologen Schilddrüsenzelltherapie, ist darauf ausgelegt, die natürliche Schilddrüsenfunktion wiederherzustellen, ohne dass Schilddrüsenhormon-Ersatzmedikamente oder Immunsuppressionsbehandlungen erforderlich sind. Präklinische Studien haben gezeigt, dass die primären Schilddrüsenhormone (T4 und T3) auf die Werte vor der Schilddrüsenoperation zurückgeführt werden konnten, als Schilddrüsengewebe in das prä- vaskularisierte Cell Pouch reimplantiert wurde. Gesundes, funktionelles Schilddrüsengewebe wurde durch Radioisotopen-Bildgebung und histologische Analysen bis zu fünf Monate nach der Implantation bestätigt.
- FDA clearance received for thyroid Cell Pouch IND application
- Preclinical studies showed successful hormone restoration without supplementation
- Functional thyroid tissue confirmed up to 5 months post-implantation
- No immune suppression therapy required
- None.
LONDON, Ontario and BOSTON, March 03, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing it’s Cell Pouch bio-hybrid organ as a functional cure for type 1 diabetes, today announced that the U.S. Food and Drug Administration (FDA) has cleared it’s Investigational New Drug (IND) application to evaluate the Company’s Cell Pouch with auto-transplanted thyroid cells in patients undergoing thyroid surgery for nodular thyroid disease.
Hypothyroidism, a condition resulting from insufficient thyroid hormone production, affects millions worldwide and can significantly impact quality of life. It is especially prevalent among patients after thyroid surgery. Sernova’s Cell Pouch bio-hybrid organ, in combination with autologous thyroid cell therapy, is designed to restore natural thyroid function by providing a stable, long-term, and physiological solution without the need for thyroid hormone replacement medications or immune suppression therapy.
"The FDA’s clearance of our IND application to investigate our Cell Pouch bio-hybrid organ in an additional indication is great progress," said Jonathan Rigby, CEO of Sernova. "This further demonstrates that our technology has the potential to play an important role in advancing cell therapies that improve the quality of life for patients suffering from chronic illnesses."
Preclinical studies have demonstrated that re-implantation of thyroid tissue into the pre-vascularized Cell Pouch, without immune suppression, successfully restored the primary thyroid hormones, thyroxine (T4) and triiodothyronine (T3), to pre-thyroidectomy levels without hormone supplementation. Radio-isotope imaging and histological analysis confirmed the presence of healthy, functional thyroid tissue within the Cell Pouch up to five months post-implantation. Receipt of FDA clearance provides Sernova with the ability to diversify its clinical trial activity in chronic conditions as the Company strengthens its financial resources.
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.
FOR FURTHER INFORMATION, PLEASE CONTACT:
David Burke VP, Investor Relations (917) 751-5713 Email: David.Burke@sernova.com Website: https://sernova.com/
The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy of this news release.
FORWARD-LOOKING INFORMATION
This press release contains forward-looking statements within the meaning of applicable Canadian securities laws. Forward-looking statements in this press release include our plan to consider the initiation of a clinical trial in patients undergoing thyroidectomy for benign nodular thyroid disease. With respect to the forward-looking statements contained in this press release, Sernova has made numerous assumptions regarding, among other things: the company’s ability to secure additional financing on reasonable terms, or at all; and the ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch, including the timing and results of those trials. A more complete discussion of the risks and uncertainties facing Sernova appears in Sernova’s Annual Information Form for the year ended October 31, 2024, filed with Canadian securities authorities and available at www.sedarplus.ca, as updated by Sernova’s continuous disclosure filings, which are available at www.sedarplus.ca. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Sernova disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
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