The US Food and Drug Administration (FDA) will decide whether to greenlight human clinical trials for Vivos’ radiation treatment device for solid tumours after the company submitted an investigational device exemption (IDE) to the agency.
An IDE allows a not-yet-approved device to be used in a clinical study to collect efficacy and safety data.
The IDE is for Vivos’ RadioGel, which comprises yttrium-90 phosphate (90YPO4) crystalline particles delivered in a hydrogel that is liquid at room temperature. The beta-emitting precision radionuclide therapy works by solidifying as it is injected directly into the tumour and reaches body temperature. This keeps the product in place, retaining the 90YPO4 particles within the tumour.
The company says the device mitigates side effects seen in external-beam radiation therapy.
US-based Vivos stated the filing to the FDA was an amendment after addressing previous comments raised by the agency in a previous application. A total of 63 FDA comments were previously raised, with the company saying that it repeated testing to address some of the issues and strengthen its data. The IDE application contained reports on two studies in rabbits with tumours, according to Vivos.
RadioGel is a human version of the company’s animal cancer treatment option, called IsoPet. The company obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet is a medical device according to its use and mechanism of action. The FDA, however, advised Vivos to use different brand names for the products to avoid confusion, despite using the same technology.
Vivos’ CEO Dr Michael Korenko 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.”
Dr Korenko said the collaboration with Mayo will initially target solid metastatic tumours in lymph nodes associated with papillary thyroid cancer.
Vivos is somewhat rare as a medical device company pursuing radionuclide therapy, with the field booming in the pharmaceutical industry. Venture financing for the wider-encompassing radiopharmaceutical drugs witnessed an increase of approximately 550% from $63m in 2017 to $408m in 2023 in terms of total deal value in the US, according to GlobalData’s Pharma Intelligence Centre Deals Database.
Big pharma has made plays for the space in the past year too, with Eli Lilly, Novartis and Bristol Myers Squibb signing deals ranging from $1.4bn to $4.1bn to acquire radiopharma specialists.
