Human Tests might come in few years
BY DAVID BRUCE david.bruce@timesnews.com
HOUSTON -- Steven Curley and his team of researchers at
M.D. Anderson Cancer Center in Houston are killing malignant
tumors in rabbits and mice with Millcreek Township inventor
John Kanzius' radio-frequency generator.
So when will they start treating humans?
Two to three years, if everything goes right, Curley
said.
"Can we do this in walking, talking human beings?" Curley
asked. "The honest answer is that we don't know yet. That's
our main concern over the next two years."
Curley, a surgical oncologist and lead investigator on
Kanzius' project, calls himself a cautious, cynical man. But
even Curley can't suppress his excitement and confidence
about Kanzius' device.
"With most experimental treatments, the time from when
you first start until the time you begin human trials is
usually eight to 12 years," Curley said. "From the time we
started working on John's device (in 2005) until human
trials will hopefully be five years. That's incredibly fast
when you're talking about research." It's not fast enough
for cancer patients who have read about Kanzius' device in
the newspaper or seen it on television newscasts.
Dozens of them call and e-mail Curley and Kanzius after a
story has run. They ask to be treated with the device right
now, because they might not be alive when trials begin.
"For every call John gets, I get 40 of them," Curley
said. "A guy called me the other day, dying of colon cancer.
He read an article about the device and begged to let us use
it on him. I had to tell him, 'Sorry, but it's not even
close to being ready for prime time.'"
Kanzius' radio-frequency devices aren't even ready to
handle human patients. Only a few inches separate the
radio-wave transmitter and receiver -- enough room for a
rabbit to fit but not a human.
This summer, Kanzius will work with Jim and Charles
Rutkowski at Industrial Sales and Manufacturing Inc., a
Millcreek-based company that manufactures Kanzius' devices.
"We'll build a device where a person can fit in on a
gurney and undergo total body irradiation," Kanzius said.
"It should take about six to eight weeks."
It's not as simple as pulling apart the transmitter and
receiver, said David Geller, M.D., principal investigator
for Kanzius' device at the University of Pittsburgh Medical
Center.
"You have to look at the effect widening that distance
will have on how the radio waves are delivered," Geller
said. "Will the device require more power?"
Though the RF generator needs to be adapted and other
questions remain, hospitals want to treat humans with the
device.
Kanzius announced March 4 that Lee Memorial Health System
in Fort Myers, Fla., would host human trials if the federal
government approves the device.
Lee Memorial, located near Kanzius' winter home in
Sanibel, is the first site chosen for the trials, which
would be held at five or six different locations.
Chief Executive Jim Nathan said the news is a boost for
his 1,600-bed, five-hospital system in southwest Florida.
"There is some really positive public relations that
comes out of it," Nathan said. "If this technology works, it
won't just help our cancer program but do a lot of good for
the patients we serve."
Kanzius said there are no plans for such an announcement
in Erie now, because the local medical community wasn't
ready to handle human trials and didn't seem eager to host
them.
After Lee Memorial was named a host site, officials from
Hamot Medical Center and Saint Vincent Health Center
contacted Kanzius and Curley. They invited Curley to their
hospitals and the Regional Cancer Center for site visits.
Curley said he plans to visit in July.
"I want Erie to have human trials," Curley said. "The
community deserves it for all the support they have given
John and the project."
Hosting human trials is important to Erie, both for
morale and economic development, said Erie Mayor Joseph
Sinnott.
"If we're on the front end of this treatment, there is a
greater probability that we will be a treatment center when
full-blown treatment is done," Sinnott said. "It would bring
a lot more people to this community, possibly from all over
the world."
Before any trials are held, the federal Food and Drug
Administration must approve them. That means the treatment
must be safe and proven to work on animals, Curley said.
"The FDA will look at everything we publish," Curley
said. "If it says yes to all of it, then we are golden. If
there is anything irregular, it's the FDA's job to poke
holes in a claim."
But Kanzius must first build that larger RF generator.
"We need it," Curley added. "Because we have the
background data to suggest we need to push to that point.
... I believe this will get to clinical trials, and the
worst thing we could do is to produce several years' worth
of great data, then look blankly at John and go, 'OK, we
don't have anything to treat a person. Now what?'"
All the devices have been manufactured through Industrial
Sales and Manufacturing.
Kanzius said at some point, a larger company must also be
brought in to handle increased production if, as hoped, the
device is successful and every cancer center, hospital and
physician's office wants one.
"I'm dying of cancer," Kanzius said, referring to his
battle with chronic lymphocytic leukemia. "I don't have the
time to see this all the way through. My plan is to license
this to a company ... and part of that agreement will be
that they promise to build the bulk of these in Erie."
Before any of that can happen, though, Curley and his
research team must find a way to send nanoparticles, tiny
pieces of carbon and gold, into cancer cells.
Kanzius' device works by sending radio waves into the
body, heating those nanoparticles until they destroy the
cancer cells. Healthy cells that don't contain nanoparticles
would be unharmed.
"That's what we will be working on for the next two
years," Curley said.
DAVID BRUCE can be reached at 870-1736 or by e-mail.
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