We are pleased to share progress updates on the following projects.
VX-2 Animal Study
Phase One testing has been completed. The data is now being analyzed and histopathology specimens have been submitted for analysis. Based on the activity decay curves, the objectives were met, and the Yttrium-90 was contained. The therapeutic ratios and activity delivered to the target volume were as high as 18,000. This is unprecedentedly high, which confirms the importance of our Precision Radionuclide Therapy device.
In addition, for tumors within the protocol size range, the therapy slowed or stopped the aggressive growth of VX-2 tumors. This is a solid indication of its effectiveness.
These preliminary data points will be shared with the FDA in April.
Tumors are now being induced for Phase Two testing. These will be treated at a lower dose to quantify the dose-escalation effect. This defines the range of doses that result in the therapeutic effectiveness of a single therapy, in the range of 100 Gy to 800 Gy. As a comparison, external beam therapy doses are typically limited to 50 – 70 Gy to minimize dose to adjacent healthy tissues.
This animal study also tested the practical application of the Injection Guidance Table. It also confirmed the accuracy of the prescribed activity placement using both mass and volume differences. They confirmed the precision of our techniques and allowed us to fine-tune the Injection Guidance Table steps. All this information has been shared with Mayo Clinic physicians, setting the stage for their surrogate injection training session in April.
Independent testing at Akina, Inc this month confirmed that premature gelation in the needle will not be a concern. Previously we explored options to increase gelation time. These data points provide us confidence in performing deep tissue injections without premature gelation for potential other future indications for use.
We concluded that we may have unintentionally confused the FDA with the wording of our Indication for Use for treating cancerous lymph nodes; so we clarified the semantics, which we will share with the FDA at our April meeting for their approval.
"RadioGel™ is a precision radionuclide therapy device for delivering therapeutic radiation to solid metastatic tumors in the lymph nodes associated with papillary thyroid cancer. These tumors are accessible by direct percutaneous injection in patients who are not surgical candidates or declined surgery."
Streamlining the Therapy Process
Capitalizing on two years of hydrogel proprietary development allowed us to refine the hydrogel formulation within our specifications. Our Instructions for Use now recommend increasing the starting temperature from the ice bath to room temperature. PET data comparison proved effective. This makes it easier for therapists.
The Peltier Chiller’s function has now evolved to keep the vial of IsoPet® solution protected from large temperature increases, mixing the particles, providing a sterile environment, and containing convenient ports to hold pre-filled syringes for treating multiple target volumes.
In a separate development, our team has designed an innovative combination shielded vial holder and shipping container. These newly developed holders meet DOT “White Label" criteria for the lowest radiation level shipments. Shielded syringes can now be filled directly from this upgraded holder. This reduces the support equipment cost, reduces the therapy preparation time, and further reduces the already low radiation exposure to the therapist, which is well below regulatory guidance levels.
Opening New Clinics
One of our objectives is to increase the number of IsoPet® therapy clinics. After locating an interested clinic in an optimum location, the first step is to ensure that they have an NRC or state-issued Radioactive Material License and are authorized to possess and use yttrium-90. We then initiate certification training.
This month the Nuclear Regulatory Commission approved the Y-90 license for Indian Creek Clinic in Fort Wayne IN. We will now begin certification training. The NRC approval sets a precedent for future licenses in MT, ID, SD, MI, MO, IN, WV, AK, CT, DE, HI, and the islands.
These are “non-agreement” states that do not have an agreement with the NRC authorizing the state to implement radiation protection regulations. Radioactive Material Licenses are issued and regulated by the NRC in these states. The initial license granted is significant because the NRC now has a “template” for licenses in other non-agreement states. Other agreement states are more likely to follow suit once an NRC license is issued.
Thank you for your continued support.
Mike Korenko, Sc. D
CEO & President Vivos, Inc.
Michael K. Korenko, Sc.D.
President & CEO