Minuscule particles engineered to cause human cells to make their own medicines, regenerate damaged organs and even send up flares to let researchers know each time they kill a cancer cell are already working in labs and poised for commercialization in a few years.
Such applications, including sending tiny robotlike machines into human cells to diagnose pathology and treat it, are likely to revolutionize medicine in the next few years, scientists predict.
An early leader is Nanosphere Inc., a Northbrook-based company that raised more than $100 million in an initial public offering this month. It is already selling a regulatory-approved nano-based genetic testing system to hospital labs.
The tests will tell physicians precisely how much blood thinner is needed to prevent clotting in a patient without triggering internal bleeding. The company also hopes to have on the market in a few years tests to diagnose heart attacks earlier and to determine whether a respiratory ailment is a bad cold or an avian flu.
While Chicago researchers were among the earliest to see nanotechnology’s health-care applications, scientists from around the world have joined the race. Dozens of cities aspire to become nanomedical centers.
“Nanosphere is just the tip of the iceberg,” said Chad Mirkin, director of Northwestern University’s nanotech institute and a Nanosphere founder. “It’s an early realization of the opportunity, but to keep this technology developing in Illinois we have to play our cards right. It won’t happen if we’re passive. This is very competitive.”
Other state governments are appropriating millions to promote nanotech industries while Illinois has been less aggressive, Mirkin said.
Nanosphere’s diagnostic tests predict which individuals are genetically inclined to have dangerous clots form in their lungs or other organs.
About one-third of the population varies greatly in how they metabolize the blood thinner warfarin. Some in this group hardly metabolize it at all, while others burn through it at twice the normal rate. Nanosphere’s test can pinpoint a patient’s genetic markers to predict metabolism, letting doctors know the best dosage for that person.
The company has more than a half-dozen other diagnostics in development that could become available within the next three years.
Some examples include tests that would spot cancer cells in the body at a much lower concentration than current technology enables and would precisely diagnose respiratory disease so physicians would know when patients had potentially fatal infections like avian flu.
Defined by a size scale — a nanometer is one-billionth of a meter — nanotechnology deals with things the size of molecules. While many people have heard the term, few have a firm idea what it means but they tend to embrace nanomedicine, said David Rejeski, director of the Project on Emerging Nanotechnologies at the Woodrow Wilson Center based in Washington, D.C.
“We’ve spent a lot of time talking to people about nanotech, 30 hours of intense focus groups,” said Rejeski. “Medical applications always come out on top. Sixty or 70 percent put that at the top of their list.”
Big growth predicted
There are more than a dozen nanomedicine devices and drugs available, with more than 150 under review by the Food and Drug Administration, Rejeski estimates. This year the pharmaceutical industry will sell more than $1 billion worth of drugs associated with nanotech, and the Freedonia Group research firm projects that the U.S. market for nanomedicine products will grow to $53 billion by 2011.
Other firms competing in nanodiagnostics include Immunicon Corp. of Huntington Valley, Pa., and CombiMatrix Molecular Diagnostics of Irvine, Calif. New diagnostic tests, such as those Nanosphere has in the works, likely will have the biggest impact on medicine in the near term, Rejeski said.
“When you reduce the number of cells it takes to detect cancer by a factor of 10 you get a much earlier start on treatment,” said Rejeski.
Nanotech tests that rapidly detect pathogens in water or food could have a tremendous impact on preventing disease, he said.
“This ripples all across health care,” he said.
Nanomedicine enables scientists to work at the same scale as nature. Nanoparticles inserted into a person’s body can signal to physicians what is happening, and they can be designed to change things.
At Purdue University, James Leary, a professor of nanomedicine, and his team are building artificial viruses that go inside cells and cause them to manufacture medicines. The nanoparticles are about a millionth the size of a human red blood cell.
They can carry small amounts of drug to a specific site where it is needed or can enter a cell and trigger mechanisms that cause the cell to become a drug factory to supply the needed therapy.
Leary hopes to create a general nanoparticle that would get FDA approval as a drug delivery vessel that could enter a person’s bloodstream and go to a target, bringing small doses of drugs already approved as therapy.
Part of the delivery package could be tiny magnetic crystals that enable clinicians to direct the vessels to their targets by applying magnetic fields outside the body. Leary’s team has employed this technology as has Dr. Axel Rosengart, an assistant professor of neurology and neurosurgery at the University of Chicago.
Rosengart’s project focuses on delivering clot-busting drugs directly to clots in stroke patients. By focusing the magnetic field where the clot is located and attracting the delivery particles there, Rosengart seeks to greatly reduce the amount of clot-busting drug administered to a patient and cut the likelihood that it will cause unintended damage.
Northwestern University’s Samuel Stupp, a materials-science professor, has developed nanoparticles that cause targeted cells to regenerate tissue, seeking to help patients afflicted by strokes or heart attacks.
Stupp’s nanoparticles mimic natural chemical signals that are not normally active in adults.
“We inject liquid into the spinal cord or the heart,” said Stupp. “The liquid contains smart molecules that when they find themselves within the body assemble into nanostructures, little cylinders, that are ready to signal the cells.”
Stupp founded a company, Nanotope, in Skokie to commercialize this technology.
Gold fights cancer
A cancer therapy developed by Mirkin uses gold nanoparticles similar to those used in Nanosphere’s diagnostic tests.
In the new application gold nanoparticles are designed to enter cells carrying genetic material that inhibits genes that make proteins that keep cells alive far beyond their normal span. This is the hallmark of cancerous cells and enabling them to die is a logical strategy to fight cancer cell by cell.
“Cells are little factories that make proteins,” said Mirkin. “Mostly the proteins keep us healthy, but sometimes they cause harm.”
Mirkin’s team has added a twist to his cancer-fighting particles in that when they bind to material in a cell they send out a signal, or “nanoflare.”
“I can track the binding events,” Mirkin said. “That gives us feedback for designing particles. It’s a new idea. Incredibly simple, extraordinarily powerful.”
Mirkin said that making progress against cancer and other disease requires new therapies and new materials with nanotech the major source.
“Everything old is new when it’s sufficiently miniaturized,” he said.
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Menu of tests against disease
WHAT NANOSPHERE DOES
Nanosphere has genetic tests that help identify patients who are prone to excessive clotting for various reasons. It also has a test to help physicians determine how quickly patients metabolize warfarin, a blood thinner, in order to tailor dosage to an individual patient.
WHAT’S NEXT?
Within the next few years the company aims to craft tests to diagnose heart attacks and cancer earlier, in addition to tests that could determine if a bad cold is really avian flu.
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Nanosphere sees profits in units’ cartridges
Nanosphere’s automated genetic testing equipment sells for $50,000 per unit, but despite the hefty price tag the Northbrook-based start-up isn’t counting on much profit selling boxes.
It’s the cartridges used for each test, which go for $65 each, where Nanosphere figures to generate revenue.
“Ours is a razor/razor blade business model,” said William Moffitt, Nanosphere’s chief executive. “We want to place our equipment in hospital labs so they’ll start buying our cartridges.”
The plastic cartridges contain genetic material, nanoparticles and chemicals made and packaged in Nanosphere’s high-tech operation. Having recently won regulatory approval from the Food and Drug Administration, Nanosphere is rolling out its products slowly, starting with half a dozen hospital labs where company representatives spend a lot of time helping hospital technicians learn to use the equipment.
“We want everything to work right the first time, so there’s a lot of hand-holding in the beginning,” said Moffitt.
The equipment is highly automated and designed to avoid errors.
William Cork, Nanosphere’s chief technology officer, said the firm used an anthropologist who studied lab technicians working at hospitals to look for weak points in the way most tests are done.
“We designed our system so technicians don’t have to read and enter data,” Cork said. “Every time you enter data, that’s an opportunity for error.”
After Nanosphere’s systems are placed and working well in a hundred or more hospital labs, Moffitt expects that word-of-mouth will start to aid the company’s sales. Nanosphere has FDA approval for two tests initially and eight more are in development.
Nanosphere uses the power of nanotech to reveal information traditional technology cannot see. Emergency rooms now routinely test people suspected of having heart attacks for troposin, a protein released when heart tissue cells die. Using nanoparticles, Moffitt said, his technology can see troposin at levels too low to register with current tests. This information will enable doctors to treat heart attacks earlier and to spot heart problems they now miss altogether.
“We want to concentrate on providing solutions in areas where there are no solutions available in the market now,” Moffitt said.
The company, which employs 110 people, raised more than $100 million this month in an initial public offering. In its IPO filing, Nanosphere said it plans to use about $50 million of the proceeds for research and development, $40 million for hiring additional sales, marketing and service personnel, and the rest as general working capital.
— Jon Van
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