Lee County leading important cancer research

COURTESY PHOTO Sanibel resident John Kanzius, left, and Dr. Steven Curley. Curley is currently testing Kanzius' new cancer fighting technology - using high frequency radio waves and nanoparticles - at his Houston clinic. Southwest Florida patients diagnosed with cancer will be some of the first people in the world to have access to technology that may obliterate the diseased cells within seconds - but they will have to wait a little longer until the Food Drug Administration approves human testing.

Last week Dr. Steven Curley, a clinical researcher at M.D. Anderson Cancer Center in Houston, and Sanibel John Kanzius, inventor of the new cancer fighting system, announced that Lee Memorial Health System will be one of six sites were human trials of the new technology will be performed.

However, researchers said it'll still be some time before human trials.

"There are a whole bunch of steps and a bunch of hoops to get through first," Curley said

While Curley has been using Kanzius' high frequency radio waves and nanoparticles to non-invasively destroy cancerous cells in mice and rabbits for about 18 months now - and noticing no side effects - he said there are numerous expensive toxicity tests that must be completed before moving on to human testing. The toxicity tests can run upwards of $1.5 million each. Additionally, there are feasibility tests, dosing questions and the necessity of proving the machine which has killed cancer cells within 120 seconds in smaller animals can work just as effectively in larger ones.

In order to get to the point where clinical trials can be conducted on humans, more than $8 million will have to be raised through donations to offset the research costs.

"We have to dot all of our i's and cross all of our t's," Curley said. "We have to make sure we are doing all of it properly."

Kanzius is working on plans to construct a larger scale model of the machinery that will resemble a CT scan and plans to have it completed by July. He said he will use dead animals, such as pigs, to check efficacy and will continue to work closely with Curley.

Administrators at Lee Memorial Health System are thrilled with the announcement.

"This research may be one of the most significant breakthroughs in cancer treatment in decades," said LMHS president Jim Nathan. "We are honored for Lee Memorial Health System to be considered as one of five to six research sites in the nation when human trials are approved. It is an indication of the physician, technical talent and leadership that we are blessed with in our community."

Officials said they believe that the fact that a new 60,000 square foot state-of-the-art cancer facility is slated to open in the community in September played a role in the decision.

It is the first time the hospital has ever been asked to participate in early Phase II clinical trials. While there are some 448 National Health Institutes clinical trials being conducted within the health system, the majority of those are in the late stages when they are made available to local residents.

"This is something that is usually restricted to academic, but because of John Kanzius and the support we gave him during his cancer journey and the community support he received, they wanted to select this as a test center," said Sharon MacDonald, vice president of oncology services at Lee Memorial Health System. "As a community cancer center, it would have been unlikely for us to get too involved in very many Phase II studies."

Kanzius is battling leukemia and is unlikely to be a candidate for early Phase II testing. While clinical testing criteria has not yet been determined, Kanzius said it is likely that the first patients to be treated will have non-soft tissue tumors and will have undergone other failed therapies.

"But, they won't be people on their death beds with a few weeks left to live," Kanzius said. "We need somebody you can follow after the treatment to see how they respond. We can't bring someone back from the brink of death. That would be setting our trials up for failure. We need to be able to prove that it works when other treatments have failed."

MacDonald said that as the Southwest Florida continues to grow, she expects to see medical research become a more important part of the community. Already, a medical research facility is in the works near the airport, she said, and at some point she expects Florida Gulf Coast University to open a medical school.

FGCU spokeswoman Susan Evans said that the school has only been open to students 10 years and there are no immediate plans to open up a medical program on the campus.

phases

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

>>Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

>>Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

>>Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

>>Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.