Vivos Advances Cancer Treatment with FDA Application for Human Trials of RadioGel

Vivos (OTCQB: RDGL), the developer of Radiogel™ Precision Radionuclide Therapy, has submitted an application to the U.S. Food and Drug Administration (FDA) to initiate human clinical trials. This move represents a significant step toward advancing cancer treatment, specifically for patients with solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.

The Investigational Device Exemption (IDE) application is an amendment addressing the FDA's comments on the company’s previous submission. Upon approval, Vivos will begin testing its innovative therapy on human subjects, targeting patients who are either ineligible for surgery or have opted against it, particularly those with non-radioiodine avid disease and limited burden regional nodal disease.

RadioGel, a groundbreaking Yttrium-90-based injectable brachytherapy device, offers a localized and potent radiation treatment. The therapy involves directly injecting a hydrogel containing Yttrium-90 phosphate microparticles into the tumor, providing a more focused radiation compared to traditional external-beam radiation therapies. This method is designed to minimize radiation exposure to surrounding healthy tissues.

This application marks Vivos’ first filing with the FDA since being granted FDA Breakthrough Device Designation for the Radiogel™ therapy. The FDA's Breakthrough Devices Program aims to expedite the development and review of innovative technologies that offer more effective treatment options. The support from this program is crucial in accelerating patient access to promising medical advancements like RadioGel. The technology behind RadioGel facilitates the safe delivery of higher doses necessary for treating non-resectable and radiation-resistant cancers. Moreover, the product's short half-life ensures that over 90% of its therapeutic radiation is delivered within ten days, significantly reducing the treatment duration compared to traditional radiation therapies that may require up to six weeks.

Since receiving the Breakthrough Device Designation, Vivos has reported improved communication with the FDA, which is pivotal for advancing this treatment. The IDE filing includes comprehensive reports on two studies – RadioGel genotoxicity and the retention of RadioGel at the injection site in VX2 tumors in rabbits. Vivos addressed the 63 FDA comments from previous correspondences and, in some instances, repeated underlying tests to fortify its application with current data.

Dr. Michael Korenko, President and CEO of Vivos, expressed optimism about the FDA's review process. “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly,” he said. “We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic's Independent Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially, our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.”

Vivos, in collaboration with the Mayo Clinic, is diligently working to develop treatments for challenging cancer types, offering hope and potentially more effective treatment options to patients worldwide. The IDE application brings Vivos one step closer to making this innovative therapy a reality.