By: Frank Gluck
From: news-press.com
Researchers studying a novel approach to treating cancer that a Sanibel man dreamed up in his garage will soon seek federal approval to start human trials on patients in Southwest Florida, Pennsylvania and Texas.
The Kanzius Cancer Research Foundation announced Tuesday that researchers will likely apply to the Food and Drug Administration in the coming weeks, after concluding animal testing of the treatment pioneered by the late John Kanzius — injecting nanoparticles into cancer cells and using radio waves to heating those cells to death.
If approved by the FDA, the first phase of any human trials would start at the Baylor College of Medicine in Houston, home to the research team leading the effort. Southwest Florida and Pennsylvania would be part of the later Phase II and III trials. Researchers are focusing on liver and pancreatic cancers, among the most difficult forms of the disease to treat.
Tuesday’s announcement comes more than a decade after John Kanzius conceived of the therapy following his own cancer diagnosis in 2002. He hoped to find a way to treat cancer that would render obsolete the painful conventional treatments, which can hurt both healthy tissue and cancer cells. Kanzius died of leukemia-related complications in 2009.
“It’s a time that we’ve been working so hard for and waiting for with such great anticipation,” Neidig told reporters and donors in a broadcast press conference in Erie, Pa., where the foundation resides. “We are one step closer to a world where cancer can be treated without side effects.”
Project researchers said last year they planned to approach the FDA in 2014 and hoped to start human trials in 2015 or 2016 and, at the request of Kanzius before he died, to include Southwest Florida patients. The foundation’s decision to hold a news conference Tuesday stemmed largely from its desire to alert donors that it would cease its own operations on June 30 in advance of this next research phase.
“We set out to go out of business,” Neidig said after the news conference. “That was the original reason for the foundation, and we’ve accomplished it.”
Once the FDA application is submitted, the federal agency has 90 days to have a face-to-face meeting with foundation researchers to discuss the proposed human trial. After that meeting, the agency has 75 days to make a judgment: Yes, no, or a request for more research.
The first phase would likely include a small group of volunteers at Baylor over a six- to eight-month period to determine the treatment is safe for humans.
Assuming that is the case, a larger Phase II trial — such FDA trials usually involve between a dozen and several hundred people — would look at its efficacy. Fort Myers would likely be one of eight to 10 locations that would participate, Neidig said. A broader Phase III trial would include hundreds of patients from multiple locations to further determine its value as a treatment option.
Early research using the Kanzius radio wave treatment on animals has been promising, according to the foundation’s published research. But, as with so many potential cancer treatments, success in animals does not mean it will be effective in humans.
Still, the idea behind the potential treatment is an interesting one, said Sharon MacDonald, vice president of oncology services for the Lee Memorial Health System’s Regional Cancer Center, which would collaborate on any human trials here.
“I think that it’s incredibly interesting,” MacDonald said. “The fact that we may have a machine that can kill very deadly cancer … with very little negative impact on the organs I think is very exciting.”
Any funds still held by the Kanzius Foundation once it ceases operations in June will be split between Baylor and the Regional Cancer Centers in Fort Myers and Erie.
The organization said it has raised $15 million since 2008, but declined to say how much of that remains to be split between the three research entities.
The foundation’s 2012 tax reports, the latest publicly available, showed the organization with a net balance of less than $500,000 at the end of that year. It also showed that it had raised only $7.2 million between 2008 and 2012.
Neidig told The News-Press the tax forms don’t reflect millions of dollars in donations since that time. He said the foundation plans to announce disbursements to the three facilities three or four months from now, after the organization pays all of its outstanding bills.
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