These are two monthly highlights of our progress.
Veterinary Cancer Society Conference:
We were a Bronze Sponsor and had a booth at the VCS conference in Norfolk, VA. We made several contacts interested in IsoPet® therapy in the USA and internationally.
Dr. Darrell Fisher delivered a presentation on Precision Radionuclide Therapy, which was well-received as a new class of therapies to treat
FDA Pre-Submission IDE process:
We had a Zoom meeting with the FDA on October 17. We submitted our Risk Management Report and a draft of the new VX-2/Rabbit Animal Study at Johns Hopkins
Key investigators from Mayo Clinic and Johns Hopkins University participated in the meeting.
The Mayo Clinic doctors reiterated that RadioGel™ is needed to improve the current standard of care to treat neck lymphadenopathy (thyroid cancerous
Since RadioGel™ delivers a large dose with a small amount of activity, it was necessary to fly a team member to JHU to determine if their PET and dose
calibrators have adequate sensitivity to address the FDA expectations.
The FDA provided feedback on the VX-2/Rabbit Animal Test Plan. We agreed to incorporate all the FDA suggestions: We increased the number of
rabbits, defined the specific times for PET quantification measurements to demonstrate, once again, that the Y-90 remains at the point of injection, and agreed to hire an independent quality
assurance consultant to meet the criteria of GLP-like testing.
The FDA accepted the Risk Management Report. This analysis concluded that under the worst-case scenario of a missed injection, the dose to any significant organ
was less than 1.4 Gy, which is insignificant. We also summarized the specific reasons that RadioGel™ is inherently safe. If the FDA accepts the draft meeting minutes, these safety
conclusions will be in the permanent record and included in our application for the IDE for clinical testing.
We closed with a slide that illustrated the effectiveness of IsoPet® in treating equine sarcoids and stated, "Currently, animals are receiving better cancer
treatment than humans."
Johns Hopkins University submitted The Institutional Animal Care and Use Committee request for animal testing.
The IACUC is mandated by federal law to oversee the University's animal care and use program, facilities, and procedures and to ensure the
appropriate care, use, and humane treatment of animals for research, testing, and education.
As always, we filed the audited 10-Q on schedule.
We obtained a one-year extension from the SEC on our Reg A vehicle to bring in additional investment as required.
Mike Korenko Sc. D
President & CEO Vivos, Inc.
Michael K. Korenko, Sc.D.
President & CEO