Tuesday, July 16, 2024

Radiation Treatment Gel Advances as Vivos Submits IDE for Human Trials

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Radiation treatment for solid tumors is at the forefront as the US Food and Drug Administration (FDA) is set to decide whether to greenlight human clinical trials for Vivos’ innovative device following the company’s submission of an investigational device exemption (IDE). An IDE allows an unapproved device to be used in a clinical study to collect data on its efficacy and safety, which is a critical step toward full market approval.

Vivos has submitted an IDE for its RadioGel device, which is designed to treat solid tumors. RadioGel comprises yttrium-90 phosphate (90YPO4) crystalline particles delivered in a hydrogel that is liquid at room temperature. Once injected directly into the tumor, the hydrogel solidifies at body temperature, keeping the radioactive particles in place. This precision radionuclide therapy aims to mitigate the side effects commonly associated with external-beam radiation therapy by containing the radiation within the tumor.

Radiation Device Advances as Vivos Submits Amended IDE Addressing FDA Comments

The company’s recent IDE submission is an amendment that addresses previous comments from the FDA. Initially, the FDA raised 63 comments regarding the application. Vivos responded by repeating tests and strengthening its data to address these issues. The IDE application included reports on two studies conducted in rabbits with tumors, which were part of the company’s efforts to demonstrate the device’s safety and efficacy.

RadioGel is the human version of IsoPet, Vivos’ animal cancer treatment. The FDA’s Center for Veterinary Medicine has confirmed that IsoPet is a medical device based on its use and mechanism of action. However, the FDA advised Vivos to use different brand names for the human and animal versions to avoid confusion, despite the technologies being identical.

Dr. Michael Korenko, Vivos’ CEO, expressed the company’s eagerness to secure the FDA’s IDE approval, which would allow them to submit their clinical trial plan to the Mayo Clinic’s independent review board (IRB). He stated, “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.” The initial clinical trials will target solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.

Radiation

Vivos Shines in Radiation Therapy Amidst Surge in Radiopharmaceutical Financing

Vivos stands out as a medical device company in the rapidly growing field of radionuclide therapy, which has traditionally been dominated by the pharmaceutical industry. According to GlobalData’s Pharma Intelligence Centre Deals Database, venture financing for radiopharmaceutical drugs increased dramatically, with total deal values in the US rising from $63 million in 2017 to $408 million in 2023, reflecting a 550% increase.

In the past year, major pharmaceutical companies have made significant moves in the radiopharmaceutical space. Eli Lilly, Novartis, and Bristol Myers Squibb have all signed deals ranging from $1.4 billion to $4.1 billion to acquire radiopharmaceutical specialists. This trend underscores the growing recognition of the potential of radionuclide therapies to offer effective treatments for various cancer types.

The FDA’s decision on Vivos’ IDE submission will be a pivotal moment for the company. Approval would not only validate the significant efforts Vivos has invested in addressing the FDA’s concerns but also pave the way for the company to begin human clinical trials. These trials are crucial for demonstrating the safety and efficacy of RadioGel in humans, which will ultimately determine whether the device can become a new standard treatment for solid tumors.

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Dr. Korenko’s optimism is shared by many in the medical community, as the successful development of RadioGel could provide a much-needed alternative to existing cancer treatments. By targeting radiation directly within the tumor and minimizing exposure to surrounding healthy tissues, RadioGel has the potential to reduce the side effects of cancer treatment and improve patient outcomes.

In summary, the FDA’s upcoming decision on Vivos’ IDE submission for RadioGel represents a significant step forward in the development of new cancer treatment options. The successful approval and subsequent clinical trials could revolutionize the treatment landscape for solid tumors, offering hope to patients facing challenging cancers. As Vivos prepares to collaborate with the Mayo Clinic on these trials, the medical community eagerly anticipates the potential advancements in cancer care that RadioGel could bring.

 

Resource: Medical Device Network, July 01, 2024

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