Vivos Inc. Launches Innovative RadioGel® Human Clinical Trial
Vivos Inc. (OTCQB: RDGL) has embarked on a pivotal journey in cancer treatment with its first human clinical trial of RadioGel® Precision Radionuclide Therapy™. This initiative, started recently, involves the treatment of five patients battling cancerous lymph nodes, marking a significant advancement in the field of oncology.
Transformation in Cancer Therapy
Taking place in India, this trial represents a major step towards meeting the growing need for advanced cancer therapies. The treatments focus primarily on establishing the safety profile of RadioGel® while ensuring each patient receives care tailored to their specific medical needs. So far, imaging confirmations have shown that the RadioGel placement has been carried out with precision, providing reassurance regarding the safety and efficacy of the treatment.
Compliance and Regulatory Approvals
Vivos is actively collaborating with health authorities to bring the promising RadioGel® therapy to patients in the United States. Regulatory approvals have been secured not only for the trial in India but also preparations are underway to commence trials at the renowned Mayo Clinic. The objective is to gather data that will validate the therapy’s safety and support further regulatory submissions.
Expanding Research and Development
The regulatory approvals allow for an expansion of the trial to a total of 30 patients, inclusive of those with cancerous nodes across various regions of the body. This critical step is designed to broaden the therapeutic applications of RadioGel®, pushing the boundaries of what this innovative treatment can achieve.
Diverse Steps Towards Progress
There are numerous milestones that have contributed to the successful launch of this clinical trial. These achievements underline the commitment of the Vivos team towards innovating cancer treatment:
- Regulatory Approvals: Vivos has obtained necessary clearances from various health committees, further strengthening the foundation of the trial.
- Comprehensive Logistics: The team acquired essential liability insurance and established detailed international shipping protocols to manage the sensitive radioactive material.
- Clinical Protocol Development: The Clinical Trial Protocol was meticulously crafted, integrating feedback from leading medical experts.
- Operational Readiness: Vivos ensured that the manufacturing process of RadioGel® met all FDA quality standards.
- Administrative and Training Steps: Agreements with treatment institutions were finalized, alongside thorough training for the medical team involved.
Leadership Insights
Dr. Michael Korenko, the CEO of Vivos Inc., emphasized the significance of this clinical trial. He noted, “The initiation of this clinical trial is a landmark moment in the evolution of cancer treatment. This effort is a culmination of rigorous planning and dedication to providing innovative therapies.” With this trial, Vivos aims to not just advance its mission but also serve the global medical community by enhancing treatment options available for cancer patients.
Understanding RadioGel® Technology
The technology behind RadioGel® is revolutionary. Utilizing Yttrium-90, this injectable therapy allows for precisely localized radiation targeting tumors directly, potentially minimizing collateral damage to surrounding healthy tissues. This unique method holds promise for greater effectiveness in treating tumors traditionally resistant to other therapies.
As the hydrogel compound settles within the tumor, it gradually releases radiation, ensuring treatment efficacy while reducing patient recovery time. This therapy’s design also allows for outpatient administration, offering convenience to patients who can return home under regular monitoring.
Innovating Veterinary Cancer Treatment
Interestingly, the innovative technology of RadioGel® is not only applicable to humans but also to veterinary medicine. The IsoPet® Solutions division within Vivos uses similar methods to provide safe and effective treatments for animals, showcasing the versatility of this pioneering approach.
Frequently Asked Questions
What is Vivos Inc. known for?
Vivos Inc. specializes in developing innovative cancer therapies, particularly focused on radionuclide therapies for both humans and animals.
What is RadioGel® Precision Radionuclide Therapy™?
It is a targeted injectable therapy that delivers localized radiation directly into tumors, aiming to minimize surrounding tissue damage.
When did the human clinical trial for RadioGel® begin?
The trial began recently with the treatment of its first five patients in India.
How many patients will be included in the expanded trial?
The trial is set to expand to include 30 patients to further investigate the effectiveness and safety of the therapy.
Who leads Vivos Inc.?
Vivos Inc. is led by Dr. Michael Korenko, the President and CEO, who emphasizes innovation and patient-centric approaches in medicine.
