Vivos Inc. Reports Encouraging Human Clinical Trial Results and Announces Expansion Plans
Vivos Inc. (RDGL) reported positive initial results from its human clinical trial of RadioGel Precision Radionuclide Therapy™. The first five patients demonstrated the treatment's safety, with PET imaging confirming Y-90 remained at injection sites and no adverse events reported. A notable case showed over 80% reduction in tumor size and metastatic activity in a patient with a cancerous node near the trachea.
The company plans to expand the trial from 30 to 50 patients, pending Ethics Committee approval. A new deep-injection CT-guided precision device will be implemented to treat deeper-seated tumors. The initial 30-patient trial is expected to complete by June 30, with the expanded trial finishing by year-end. Results will be submitted to medical journals and shared with FDA to support RadioGel®'s IDE submission.
Vivos is working with IsoTherapeutics (now part of Telix) to increase production capacity for Isopet™ and RadioGel®, while exploring additional manufacturing partnerships globally.
Vivos Inc. (RDGL) ha riportato risultati iniziali positivi dai suoi trial clinici umani riguardanti la RadioGel Precision Radionuclide Therapy™. I primi cinque pazienti hanno dimostrato la sicurezza del trattamento, con immagini PET che confermano la presenza di Y-90 nei siti di iniezione e senza eventi avversi riportati. Un caso notevole ha mostrato oltre un 80% di riduzione nella dimensione del tumore e nell'attività metastatica in un paziente con un nodulo canceroso vicino alla trachea.
La società prevede di espandere il trial da 30 a 50 pazienti, in attesa dell'approvazione del Comitato Etico. Sarà implementato un nuovo dispositivo di precisione guidato da CT per iniezioni profonde per trattare tumori più radicati. Si prevede che il primo trial di 30 pazienti si concluda entro il 30 giugno, con l'espansione del trial che terminerà entro la fine dell'anno. I risultati saranno presentati a riviste mediche e condivisi con la FDA per supportare la presentazione IDE di RadioGel®.
Vivos sta collaborando con IsoTherapeutics (ora parte di Telix) per aumentare la capacità produttiva di Isopet™ e RadioGel®, mentre esplora ulteriori partnership di produzione a livello globale.
Vivos Inc. (RDGL) informó sobre los resultados iniciales positivos de su ensayo clínico humano de RadioGel Precision Radionuclide Therapy™. Los primeros cinco pacientes demostraron la seguridad del tratamiento, con imágenes PET que confirmaron que el Y-90 permanecía en los sitios de inyección y sin eventos adversos reportados. Un caso notable mostró una reducción de más del 80% en el tamaño del tumor y la actividad metastásica en un paciente con un nódulo canceroso cerca de la tráquea.
La compañía planea expandir el ensayo de 30 a 50 pacientes, pendiente de aprobación del Comité de Ética. Se implementará un nuevo dispositivo de precisión guiado por CT para la inyección profunda para tratar tumores más profundos. Se espera que el ensayo inicial de 30 pacientes se complete para el 30 de junio, con la expansión del ensayo finalizando a finales de año. Los resultados serán enviados a revistas médicas y compartidos con la FDA para apoyar la presentación IDE de RadioGel®.
Vivos está trabajando con IsoTherapeutics (ahora parte de Telix) para aumentar la capacidad de producción de Isopet™ y RadioGel®, mientras explora asociaciones de fabricación adicionales a nivel mundial.
비보스 인크. (RDGL)는 RadioGel 정밀 방사성 동위원소 치료법™에 대한 인간 임상 시험의 초기 긍정적인 결과를 보고했습니다. 첫 다섯 명의 환자는 치료의 안전성을 입증했으며, PET 이미지는 Y-90이 주사 부위에 남아 있으며 부작용이 보고되지 않았음을 확인했습니다. 주목할 만한 사례에서 한 환자는 기관지 근처의 암 덩어리에 대해 80% 이상의 종양 크기 및 전이 활동 감소를 보였습니다.
회사는 윤리위원회의 승인을 기다리며 참가자를 30명에서 50명으로 늘릴 계획입니다. 더 깊은 종양을 치료하기 위해 CT 유도 정밀 장치가 구현될 것입니다. 초기 30명 환자 시험은 6월 30일에 완료될 것으로 예상하며, 확대된 시험은 연말까지 완료될 것입니다. 결과는 의학 저널에 제출되고 RadioGel®의 IDE 제출을 지원하기 위해 FDA와 공유될 것입니다.
비보스는 IsoTherapeutics(현재 Telix의 일부)와 협력하여 Isopet™와 RadioGel®의 생산 능력을 늘리는 한편, 전 세계적으로 추가 제조 파트너십을 탐색하고 있습니다.
Vivos Inc. (RDGL) a rapporté des résultats initiaux positifs de son essai clinique humain sur la RadioGel Precision Radionuclide Therapy™. Les cinq premiers patients ont démontré la sécurité du traitement, les images PET confirmant que le Y-90 restait sur les sites d'injection et aucun effet indésirable signalé. Un cas notable a montré une réduction de plus de 80% de la taille de la tumeur et de l'activité métastatique chez un patient avec un nodule cancéreux près de la trachée.
L'entreprise prévoit d'élargir l'essai de 30 à 50 patients, en attendant l'approbation du Comité d'Éthique. Un nouvel appareil de précision guidé par tomodensitométrie (CT) sera mis en œuvre pour traiter les tumeurs plus profondes. L'essai initial de 30 patients devrait être achevé d'ici le 30 juin, et l'essai élargi se terminera d'ici la fin de l'année. Les résultats seront soumis à des revues médicales et partagés avec la FDA pour soutenir la soumission IDE de RadioGel®.
Vivos collabore avec IsoTherapeutics (maintenant partie de Telix) pour augmenter la capacité de production d'Isopet™ et de RadioGel®, tout en explorant d'autres partenariats de fabrication à l'échelle mondiale.
Vivos Inc. (RDGL) berichtete über positive erste Ergebnisse aus seiner klinischen Studie mit Menschen zur RadioGel Precision Radionuclide Therapy™. Die ersten fünf Patienten zeigten die Sicherheit der Behandlung, wobei PET-Bilder bestätigten, dass Y-90 an den Injektionsstellen verblieb und keine unerwünschten Ereignisse gemeldet wurden. Ein bemerkenswerter Fall zeigte eine Über 80%ige Reduktion der Tumorgröße und der metastatischen Aktivität bei einem Patienten mit einem krebsartigen Knoten in der Nähe der Luftröhre.
Das Unternehmen plant, die Studie von 30 auf 50 Patienten zu erweitern, vorbehaltlich der Genehmigung des Ethikkomitees. Ein neues CT-gesteuertes Präzisionsgerät für tiefe Injektionen wird implementiert, um tiefer sitzende Tumoren zu behandeln. Die erste 30-Personen-Studie wird voraussichtlich bis zum 30. Juni abgeschlossen sein, während die erweiterte Studie bis Ende des Jahres abgeschlossen sein soll. Ergebnisse werden an medizinische Zeitschriften eingereicht und mit der FDA geteilt, um die IDE-Einreichung von RadioGel® zu unterstützen.
Vivos arbeitet mit IsoTherapeutics (jetzt Teil von Telix) zusammen, um die Produktionskapazität für Isopet™ und RadioGel® zu erhöhen, während das Unternehmen zusätzliche globale Produktionspartnerschaften erkundet.
- Initial safety confirmation in first five patients with no adverse events
- 80% reduction in tumor size and metastatic activity in one patient case
- Planned trial expansion from 30 to 50 patients
- New deep-injection technology implementation for treating deeper tumors
- Manufacturing capacity expansion through partnership with Telix-owned IsoTherapeutics
- data from only five patients so far
- Full trial completion not expected until year-end
- Still pending Ethics Committee approval for trial expansion
Richland, WA, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) is pleased to report that the first five patients demonstrated the safety of RadioGel Precision Radionuclide TherapyTM by satisfying the criteria in the Clinical Study Plan, including confirmation via PET imaging that the Y-90 remained at the point of injection and no adverse events reported by any of the initial five patients since the initial treatment date.
Additionally, 30-day PET/F-18 imaging of a local patient—a young teacher with a cancerous node near the trachea—revealed an over
Expansion of Clinical Trial
After completing the detailed assessment of the available data from the patients, the results will be presented to the Ethics Committee. The lead investigator intends to request authority to increase the study from 30 patients to 50 patients. The expanded trial will provide valuable data on a variety of cancers and include the utilization of new deep injection technology being installed and tested in the treatment hospital in India.
This advanced deep-needle CT-guided precision injection device, designed for use with RadioGel®, will enable precise treatment of deeper-seated tumors, including lung and pancreatic cancer nodules.
Under the current timeline, we anticipate completing the initial 30-patient trial by June 30 and the expanded trial by year-end. Consistent with our previous disclosure, the trial’s comprehensive data will be submitted under the guidance of the lead investigator for publication in leading medical journals. Additionally, as results emerge, they will be shared with the FDA to further support RadioGel®’s safety profile and reinforce our Investigational Device Exemption (IDE) submission and advance expanded indications for use in the United States.
Manufacturing and Global Expansion
Vivos continues to collaborate with its contract manufacturer, IsoTherapeutics, recently acquired by Telix (Nasdaq: TLX), to enhance production capacity for both Isopet™ and RadioGel®. Simultaneously, we are evaluating additional manufacturing partners in India and other regions to support global supply chain expansion.
Statement of CEO Mike Korenko:
“After years of dedicated effort, we are thrilled with these initial clinical trial results and optimistic about future findings. As the study progresses, we look forward to sharing additional updates. In parallel, we are advancing key growth initiatives to strengthen RadioGel®’s competitive position, and we will provide further updates on these technology and business developments in the coming weeks and months.”
– Michael K. Korenko, Sc.D.
President & CEO, Vivos Inc.
Follow Vivos Inc @VivosIncUSA, Radiogel® and Isopet® on X (Twitter):
For media inquiries, contact:
Michael K. Korenko, Sc.D.
President & CEO, Vivos Inc.
Email: MKorenko@RadioGel.com
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90-based injectable Precision Radionuclide Therapy™ medical device to treat tumors in animals (IsoPet®) and humans (RadioGel®). Using the company's proprietary hydrogel technology, PRnT™ uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers.
RadioGel® is a hydrogel liquid containing tiny yttrium-90 phosphate microparticles that may be administered directly into a tumor. The hydrogel is a yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
RadioGel® also has a short half-life – delivering more than
University veterinary hospitals use the IsoPet® Solutions division to demonstrate animal cancers' safety and therapeutic effectiveness. Testing on feline sarcoma at Washington State University was completed in 2018, and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019. The Company has obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling, which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices, so no additional approval was required to generate revenue through the sale of IsoPet® to University animal hospitals and private veterinary clinics.
IsoPet® for treating animals uses the same technology as RadioGel® for treating humans. The Food and Drug Administration advised using different product names to avoid confusion and cross-use.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners, and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
FAQ
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