Kanzius cancer treatment to go before the FDA
The Kanzius Cancer Research Foundation announced it will dissolve itself as of June 30, but the cancer-fighting technology it helped to develop is poised for approval by the Food and Drug Administration (FDA).
Sanibel Island resident John Kanzius, who died in 2009 from complications related to the chemotherapy he received for non-Hodgkin’s lymphoma, developed the Kanzius Noninvasive Radiowave Cancer Treatment.
The treatment coats cancer cells with nanoparticles using a unique antibody and then essentially burns them away with focused radio waves.
Foundation Executive Director Mark A. Neidig met with the public and donors on May 23 to explain that it was closing because the foundation felt that it had accomplished its goal. Formed by a group of Kanzius’ dedicated friends, it has been the project’s primary source of funding for the last five years.
Neidig said that the foundation’s goal had been to bring national and global awareness to the project, and to provide the necessary funds to bring the technology to human trials.
“We have funded all of the research necessary to get to and through human trials. This is what we set out to do and we are without any question celebratory,” he said. “The one thing we have always kept in the forefront of our minds is our mission statement.”
The cancer treatment is not at the point of human trial. The machine has been continually evolving for the last decade and the subjects have changed from petri dishes to mice and rabbits, and now the tests are being done on pigs.
Researchers are preparing an application to the FDA as early as August in order to show the evidence they have compiled and ask for approval to begin testing it on humans. The FDA is required by law to meet with any applicant within 90 days and to make a decision within an additional 75 days.
“They aren’t going to stop things because there are so many great pieces of data,” said Neidig. “Every indication shows that the research is strong.”
Human trials would have a total of four phases, each one growing progressively larger with more participating patients and facilities, and the FDA even has the power to bypass the process if the evidence is overwhelmingly strong.
Neidig said that, in the best case scenario, phase one of human testing could begin as early as 2015.
The lead researchers, Dr. Steven Curley from the Baylor College of Medicine and Dr. David Geller from the University of Pittsburgh Medical Center, would have to develop a strict set of criteria for human trials and ensure that patients match the requirements.
The rights over the device, the Kanzius Noninvasive Radiowave Cancer Treatment, were acquired from Therm Med LLC by the Houston-based AkesoGenX Corp. in January 2014. AkesoGenX’s mission is to provide alternative, noninvasive cancer therapy to patients and commercialize the technology, if the results are positive.
Once the Kanzius Cancer Reseach Foundation closes on June 30 it will no longer accept donations and the remaining assets will be divided among separate funds for the Lee Memorial Health System; The Regional Cancer Centers in Erie, Pennsylvania; the Baylor College of Medicine; and other locations that are conducting research.
Before passing away, Kanzius said that he wanted human trials be done in Fort Myers and Erie, Pennsylvania, and Neidig said that the researchers will be able to honor that wish.