Vivos Inc. (OTCQB: RDGL) has announced the commencement of its first human clinical trial for RadioGel® Precision Radionuclide Therapy™ in India. The trial, which has already treated five patients with cancerous lymph nodes, marks a significant advancement in innovative cancer therapies. The initial focus is on demonstrating the safety of the therapy.
Trial Design and Objectives
The clinical trial in India mirrors the protocol intended for a future study at the Mayo Clinic in the United States. The first phase involved treating five patients with cancerous nodes in the neck. Imaging confirmed the accurate placement of RadioGel®, and patients are reportedly recovering without complications. Vivos is actively engaged in discussions with the FDA to initiate human clinical trials at the Mayo Clinic, with the data from the Indian trial intended to bolster RadioGel®'s safety profile and support the Investigational Device Exemption (IDE) submission.
The study has received regulatory clearance to expand to 30 patients, encompassing cancerous nodes throughout the body. The comprehensive data from this expanded trial is expected to be submitted for publication in a leading medical journal in the first half of 2025.
RadioGel® Technology
RadioGel® is a hydrogel liquid containing yttrium-90 phosphate microparticles designed for direct injection into tumors. The hydrogel acts as a carrier, solidifying within the tumor's interstitial spaces to keep the radiation source localized. The short-range beta radiation from yttrium-90 delivers a concentrated dose to the treatment area, minimizing adverse effects on surrounding healthy tissues. Furthermore, RadioGel® has a short half-life, delivering over 90% of its therapeutic radiation within 10 days, which is notably faster than other radiation therapy options that can take up to six weeks.
Regulatory and Logistical Achievements
The initiation of the clinical trial in India was enabled by several key milestones, including:
- Securing regulatory approvals from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) in India.
- Acquiring liability insurance and expanding the treatment institution's radioactive material license.
- Finalizing the Clinical Trial Protocol, incorporating Mayo Clinic study designs and FDA feedback.
- Re-validating RadioGel® manufacturing to comply with Quality Management System standards and FDA recommendations.
Leadership Perspective
Dr. Michael Korenko, President & CEO of Vivos Inc., stated, "The initiation of this clinical trial marks an historic moment in the evolution of cancer treatment... We are making history by advancing RadioGel® Precision Radionuclide Therapy™ into its first human trials. This trial represents not just a milestone for Vivos, but a pivotal moment for the entire field of oncology."
