Vivos Inc has reported positive results with its first ever human trial

This could lead to a revolution in cancer treatments. Vivos Inc. RDG, the maker of the RadioGel® Precision Radionuclide Therapy™, has reported positive results from its first-ever human trial. 

RadioGel®, a pioneering Yttrium-90-based injectable medical device, represents what the company says is a groundbreaking approach to cancer treatment. The device is intended for solid tumor patients who either are not candidates for surgery, or do not wish to have it performed. This includes those with limited regional nodal involvement and non-radioiodine affluent disease. This therapy is administered by injecting a microparticle-containing hydrogel containing Yttrium 90 phosphate directly into the tumor. This allows a more targeted and powerful radiation treatment when compared with traditional external-beam therapies.

In December the company said it would be conducting its first human trials in India. As of February, Vivos Inc. reported that the first eight patients demonstrated the safety of RadioGel® Precision Radionuclide TherapyTM by satisfying the criteria in the Clinical Study Plan, which included confirmation via PET imaging that the Y-90 remained at the point of injection and no adverse events were reported since the initial treatment date.

PET images confirmed that all patients in the study had met the primary endpoint of safety as of April. PET imaging showed precise retention of therapeutic Yttrium 90 isotopes at the injection sites, and no adverse events were observed. Patients are recovering with no reported complications. Two of the 10 patients had tumors that were in contact with the carotid and trachea, areas often considered to be inoperable, or at high risk for radiation injury. The study showed that RadioGel® achieved successful treatment without injuring adjacent critical tissues, highlighting the therapy’s high Therapeutic Ratio and the core rationale behind the FDA’s Breakthrough Device designation.

More encouragingly, one of the local patients—a young teacher with a cancerous node near the trachea—revealed an over 80% reduction in both tumor size and metastatic activity. Vivos’ treatment spared the patient any side effects that might have been caused by alternative treatments, such as a loss of voice. 

What are the next steps and applications in the United States? 

Vivos Inc. anticipates that the principal investigator will request permission to expand the study to include 50 patients, after the Ethics Committee has reviewed the data. This expanded trial will give valuable data about a wide range of cancers. It also includes the use of new deep-injection technology that is being tested and installed in Bangalore’s treatment hospital.

Although the IDE submission is not dependent on completing the international trials, as results emerge, they will be shared with the FDA to further support RadioGel®’s safety profile and reinforce their Investigational Device Exemption (IDE) submission and advance expanded indications for use in the United States.

The Mayo Clinic, in the United States, has planned a study that will closely match the protocol of the company’s initial Indian trial. The FDA awarded Breakthrough Devices to the firm in the past. This program is designed to speed up the evaluation and development of technologies which have the potential for better treatment. The program’s support is instrumental in hastening patient access to promising medical advancements like RadioGel®. It is hoped that the company’s dual-track strategy for international expansion will help accelerate global adoption of this innovative cancer treatment.

“At Vivos, our policy is to communicate results—not just promises. It is an historic event in the history of cancer treatments that this clinical study has begun. This is the culmination of our meticulous planning, strategy execution and unwavering dedication to innovation. We are making history by advancing RadioGel® Precision Radionuclide Therapy™ into its first human trials. Vivos, Inc. has achieved a significant milestone in this trial. It is also an important moment for oncology. “We are eager to share preliminary findings soon, and then comprehensive results upon the completion of this trial,” said CEO Mike Korenko.

Unsplash: National Cancer Institute – Featured Photo

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