Vivos (OTCQB: RDGL), the developer behind Radiogel™ Precision Radionuclide Therapy, has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to initiate human clinical trials. This marks a significant step forward in the treatment of solid metastatic tumors, particularly those in lymph nodes associated with papillary thyroid cancer.
The IDE application addresses prior FDA comments and, upon approval, will allow Vivos to begin testing its therapy on human subjects. This development is particularly important for patients who are not eligible for surgery or have opted out of it, especially those with non-radioiodine avid disease and limited burden regional nodal disease.
RadioGel, a Yttrium-90-based injectable brachytherapy device, represents a groundbreaking approach to cancer treatment. It involves direct injection of a hydrogel containing Yttrium-90 phosphate microparticles into the tumor, providing a localized and potent radiation treatment. This method stands in stark contrast to traditional external-beam radiation therapies, which often have broader and less concentrated impacts.
This submission is Vivos' first since the FDA granted Breakthrough Device Designation to RadioGel™ Precision Radionuclide Therapy. The FDA's Breakthrough Devices Program aims to expedite the development and review of technologies that offer more effective treatment options. This designation helps accelerate patient access to promising medical advancements such as RadioGel.
The technology behind RadioGel allows for the safe delivery of higher radiation doses necessary for treating non-resectable and radiation-resistant cancers. Additionally, the product has a short half-life, delivering over 90% of its therapeutic radiation within ten days. This is a significant improvement over other treatments that can take up to six weeks for a full course of radiation therapy. Furthermore, the outpatient nature of RadioGel therapy means patients can return home without concerns about exposing family members to radiation.
Since receiving the Breakthrough Device status, Vivos has reported improved communication with the FDA. The IDE filing includes reports on two studies: RadioGel genotoxicity and the retention of RadioGel at the injection site in VX2 tumors in rabbits. The company addressed 63 FDA comments from previous correspondences and, in some cases, repeated underlying testing to strengthen its responses with current data.
Dr. Michael Korenko, President and CEO of Vivos, emphasized the importance of securing the FDA's IDE approval to proceed with submitting their plan to the Mayo Clinic's Independent Review Board (IRB) for clearance to initiate the first human clinical trials. "We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic's 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," Korenko stated.
In collaboration with the Mayo Clinic, Vivos is focused on developing treatments for challenging cancer types, offering hope and potentially more effective treatment options to people worldwide. The IDE application puts Vivos one step closer to making this innovative treatment a reality.
Photo by National Cancer Institute on Unsplash.
