The first month of 2023 has come to a close, and we're pleased to share our business recap and updates for the end of January. Please read through.
Vivos Inc filed a utility patent on alternate particles in the USA and internationally via the Patent Cooperation Treaty, PCT. We are convinced that precision radionuclide therapy will become increasingly important for future cancer therapy in animals and humans. We will remain focused on IsoPet/RadioGel Yttrium-90 beta therapy, which we believe is the best beta emitter; however, we leveraged our hydrogel utility patent to incorporate other promising isotopes and compounds for a range of future applications. This includes gamma and alpha particle emitters. This will place us in a strong future intellectual property position.
ANIMAL TEST PLAN
Growing VX-2 tumors takes more work. We completed the scoping study to verify the VX-2 model and used the growth rate to fine-tune the details of the timing of the testing plan. As requested by the FDA, we contracted an independent quality assurance contractor to monitor the testing. After the final “full dress rehearsal” surrogate training session, we will initiate testing demonstrating all aspects of injection planning and implementation.
MAYO CLINIC PROTOCOL
We submitted the final draft of the Mayo Clinic Protocol for human therapy and the Instructions for Use to Dr. Paz Fumagalli. He forwarded it to the Protocol Development Unit, which will negotiate the budget before sending it to their IRB after the IDE approval. We have been working on this protocol for more than three years. It required demonstration testing in mouse spleens, more than 35 revisions to the Injection Guidance and Activity Tracking Table, surrogate training, and refinements to our injection system.
(Mike Korenko, Sc.D • Vivos Inc. CEO • President)
FDA IDE SUBMITTAL
We submitted the revised IDE to the FDA and asked to schedule another pre-submission meeting. The IDE included responses to previous written FDA comments and all the pre-clinical testing required for the IDE, except for the aseptically fill validation and the animal study. This had two years of effort on biocompatibility assurance in 85 animals.
QUALITY MANAGEMENT SYSTEM
We incorporated ten additional documents into our Quality Management System. Behind the scenes, our company has spent the last three years strengthening our Quality Management System. Any future human therapies must be strong in this area and anticipate strict FDA audits.
We now have 91 signed documents on our Cloud, many of which have been revised and improved more than once. Several of these define our specifications based on many months of optimization on our particle and polymer/hydrogel components, working with some of the best companies in this country.
We are entering the final phase of validating our key procedures. This includes production to specification, sterility, shelf-life, and pre-mixing of our components. We confirmed the particle production sterility and are engaged in the aseptically filled sterilization validation for the hydrogel.
All three patients treated at Johns Hopkins and Brew at Vista Veterinary Hospital have no signs of cancer recurrence. Brew was treated at Vista Veterinary Hospital. He had very advanced cancer, but IsoPet® prevented an amputation.
We reviewed all the commercial IsoPet® therapy cases over the last three years. We determined that, even though we treated several very advanced tumors, they had an approximate 65% Complete Response (CR) using the official RICIST criteria. This demonstrates that IsoPet® is an effective tool. We are currently directing efforts to increase the number of regional clinics and the number of new patients.
Thank you for your continued support.
Mike Korenko, Sc. D
CEO & President Vivos, Inc.
Michael K. Korenko, Sc.D.
President & CEO