• VX-2 Animal Study Initiated | Draft IDE Submission to the FDA
VX-2 Animal Study Initiated
After several months of planning, preparation, and FDA review the first VX-2 tumors were injected with low-activity IsoPet® to deliver a very high 800 Gy dose. The local activity is now being measured over time using PET-CT to demonstrate that the IsoPet® will kill the VX-2 tumors and that the hydrogel effectively keeps the Yttrium-90 at the point of injection, thus limiting the migration to other areas of the body.
Just prior to this injection a full-dress rehearsal into surrogate tissue was conducted to demonstrate the refined precision techniques using our new Injection Guidance and Activity Tracking Table and our newly patented Peltier Chiller and ancillary equipment. This precision is required when injecting < 0.2 cc into a 1 cc tumor based on the calculated recommendation from our guidance table. This exact technique will be used by Mayo Clinic to eventually treat cancerous lymph nodes. Mayo is scheduled to conduct its own surrogate tissue training exercise in April.
We have now demonstrated that our standardized procedures and support equipment can be used to treat tumors ranging from these small sizes to very large (up to a pound) equine tumors.
Draft IDE Submitted to the FDA
All the pre-clinical testing is completed, except for the VX-2/rabbit study, so we submitted a draft IDE. It is prudent to obtain continuous FDA feedback to expedite the final submittal. It is anticipated that the FDA comments will be received in early April. After the animal study is completed the final draft of the IDE will be submitted.
Mike Korenko, Sc.D • CEO • President
The Effort to Qualify Additional Vendors for our Key Product Components
As reported earlier this month, evolving away from single-source production of the primary components of IsoPet/RadioGel is a strategic objective.
Last year we developed two alternate suppliers for the polymer that is used to produce the hydrogel component. This year we are focusing on locating a second supplier for our yttrium phosphate particles.
This month an Eckert & Ziegler representative observed a full production run at IsoTherapeutics, our current component supplier, to create a solid basis for future meaningful discussions.
Thank you for your continued support.
Mike Korenko, Sc. D
CEO & President Vivos, Inc.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
Home Page Cover Image:
Veterinarian Dr. Michelle Myer from Vista Veterinarian Hospital in Kennewick, WA.
Seen here administering IsoPet® therapy to a feline suffering from a sarcoma.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 (90Y) phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
IsoPet® Therapy Application(s)
Precision Radionuclide Therapy (PRnT)
Vivos Inc. - (OTCQB: RDGL) Investor Relations
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