Sernova Biotherapeutics Submits IND Application for its Cell Pouch Bio-Hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism
Sernova Biotherapeutics (SEOVF) has submitted an Investigational New Drug (IND) application to the FDA for its Cell Pouch bio-hybrid organ with autologous thyroid cells to treat hypothyroidism in patients undergoing total thyroidectomy. The technology aims to restore natural thyroid function without requiring immune suppression therapy.
Preclinical trials have shown promising results, demonstrating that reimplanting thyroid tissue into the pre-vascularized Cell Pouch restored thyroxine (T4) and triiodothyronine (T3) hormones to pre-thyroidectomy levels without hormone supplementation. Imaging and histology confirmed functional thyroid tissues within the Cell Pouch five months post-reimplantation.
Upon FDA clearance, Sernova plans to initiate a first-in-human clinical trial to evaluate safety, tolerability, and efficacy in patients undergoing thyroidectomy for benign nodular disease.
Sernova Biotherapeutics (SEOVF) ha presentato una domanda per un Nuovo Farmaco in Investigazione (IND) alla FDA per il suo organo bio-ibrido Cell Pouch con cellule tiroidee autologhe, per trattare l'ipotiroidismo nei pazienti sottoposti a tiroidectomia totale. La tecnologia mira a ripristinare la funzione tiroidea naturale senza richiedere una terapia di immunosoppressione.
Gli studi preclinici hanno mostrato risultati promettenti, dimostrando che il reimpianto di tessuto tiroideo nel Cell Pouch pre-vascolarizzato ha ripristinato i livelli di ormoni tiroxina (T4) e triiodotironina (T3) ai valori precedenti alla tiroidectomia senza supplementazione ormonale. Immagini e istologia hanno confermato la presenza di tessuti tiroidei funzionali all'interno del Cell Pouch cinque mesi dopo il reimpianto.
Una volta ottenuta l'approvazione dalla FDA, Sernova prevede di avviare un trial clinico di prima fase sull'uomo per valutare la sicurezza, la tollerabilità e l'efficacia in pazienti sottoposti a tiroidectomia per malattia nodulare benigna.
Sernova Biotherapeutics (SEOVF) ha presentado una solicitud de Nuevo Medicamento en Investigación (IND) a la FDA para su órgano bio-híbrido Cell Pouch con células tiroideas autólogas, para tratar el hipotiroidismo en pacientes que se someten a tiroidectomía total. La tecnología tiene como objetivo restaurar la función tiroidea natural sin requerir terapia de inmunosupresión.
Los ensayos preclínicos han mostrado resultados prometedores, demostrando que el reimplante del tejido tiroideo en el Cell Pouch prevascularizado restauró los niveles de hormonas tiroxina (T4) y triyodotironina (T3) a niveles previos a la tiroidectomía sin suplementación hormonal. Imágenes e histología confirmaron la presencia de tejidos tiroideos funcionales dentro del Cell Pouch cinco meses después del reimplante.
Una vez que obtenga la autorización de la FDA, Sernova planea iniciar un ensayo clínico de primera fase en humanos para evaluar la seguridad, la tolerabilidad y la eficacia en pacientes sometidos a tiroidectomía por enfermedad nodular benigna.
세르노바 생물 의약품 (SEOVF)는 총 갑상선 절제술을 받은 환자의 저갑상선증 치료를 위해 자가 갑상선 세포로 만든 Cell Pouch 바이오 하이브리드 장기에 대한 임상시험 신약신청서 (IND)를 FDA에 제출했습니다. 이 기술은 면역 억제 치료 없이 자연적인 갑상선 기능을 회복하는 것을 목표로 합니다.
전임상 시험에서 유망한 결과가 나타났으며, 미리 혈관화된 Cell Pouch에 갑상선 조직을 재이식하였을 때 갑상선 절제술 이전 수준으로 티록신 (T4)과 트리요드티로닌 (T3) 호르몬이 회복되었음을 보여주었습니다. 이미징 및 조직학적 분석은 재이식 후 5개월 동안 Cell Pouch 내에서 기능적인 갑상선 조직을 확인했습니다.
FDA의 승인이 나면, 세르노바는 양성 결절 질환으로 갑상선 절제술을 받은 환자에서 안전성, 내약성 및 효능을 평가하기 위한 첫 번째 인체 임상 시험을 시작할 계획입니다.
Sernova Biotherapeutics (SEOVF) a soumis une demande de Nouveau Médicament en Investigation (IND) à la FDA pour son organe bio-hybride Cell Pouch avec des cellules thyroïdiennes autologues, destiné à traiter l'hypothyroïdie chez les patients subissant une thyroïdectomie totale. La technologie vise à restaurer la fonction thyroïdienne naturelle sans nécessiter de thérapie immunosuppressive.
Les essais précliniques ont montré des résultats prometteurs, démontrant que le réimplantation de tissu thyroidien dans le Cell Pouch prévascularisé a restauré les niveaux d'hormones thyroxine (T4) et triiodothyronine (T3) aux valeurs antérieures à la thyroïdectomie sans supplémentation hormonale. Les imageries et l'histologie ont confirmé la présence de tissus thyroïdiens fonctionnels à l'intérieur du Cell Pouch cinq mois après le réimplantation.
Suite à l'approbation de la FDA, Sernova prévoit de lancer un essai clinique de première en humanité pour évaluer la sécurité, la tolérabilité et l'efficacité chez les patients subissant une thyroïdectomie pour maladie nodulaire bénigne.
Sernova Biotherapeutics (SEOVF) hat einen Antrag für ein Investigational New Drug (IND) bei der FDA für sein bio-hybridisches Organ Cell Pouch mit autologen Schilddrüsenzellen eingereicht, um Hypothyreose bei Patienten zu behandeln, die sich einer totalen Schilddrüsenentfernung unterziehen. Die Technologie zielt darauf ab, die natürliche Schilddrüsenfunktion wiederherzustellen, ohne eine Immuntherapie erforderlich zu machen.
Präklinische Studien haben vielversprechende Ergebnisse gezeigt und demonstriert, dass die Reimplantation von Schilddrüsengewebe in das vorgebarrierte Cell Pouch die Spiegel der Schilddrüsenhormone Thyroxin (T4) und Triiodthyronin (T3) auf die Werte vor der Schilddrüsenentfernung ohne Hormonersatz wiederherstellt. Bildgebende Verfahren und Histologie bestätigten funktionale Schilddrüsengewebe innerhalb des Cell Pouch fünf Monate nach der Reimplantation.
Nach der Genehmigung durch die FDA plant Sernova, eine erste klinische Studie am Menschen zu initiieren, um Sicherheit, Verträglichkeit und Wirksamkeit bei Patienten zu evaluieren, die sich wegen benigner nodulärer Erkrankungen einer Schilddrüsenentfernung unterziehen.
- Successful preclinical trial results showing hormone restoration to pre-thyroidectomy levels
- Technology eliminates need for immune suppression therapy
- Confirmed presence of functional thyroid tissue after 5 months in preclinical studies
- FDA approval still pending for clinical trials
- No human trial data available yet
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.
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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