Microchip successfully delivers bone-loss drug: study

A microchip inserted under the skin has been shown for the first time to successfully deliver a bone-loss drug to a small sample of women, according to US-led research published Thursday.

The device may someday allow patients to avoid daily injections of medication and permit doctors to adjust their doses from afar, said the study which appears in the journal Science Translational Medicine.

"We hope this really is the dawn of a whole new way of thinking about delivering medications," said co-author Robert Langer, a professor of cancer research at the Massachusetts Institute of Technology.

Langer and colleagues presented their findings at the annual meeting of the American Association for the Advancement of Science in Vancouver, Canada. Langer addressed the conference by phone.

The device is about the size of a pacemaker, or a computer flash stick, and contains daily doses of medication inside small wells that open up either on a predetermined schedule, or when the chip is given a wireless signal to release the drugs.

Each well is covered by a nano-thin layer of gold which protects the drug and prevents it from being released.

The wireless signal causes the gold to dissolve and allows the drug to enter the bloodstream.

In this case, researchers tested the device on seven women aged 65-70 in Denmark who were prescribed the drug teriparatide for osteoporosis. The microchip was implanted just below their waistlines.

After tracking the women for 12 months, researchers found that the treatment improved bone formation and reduced the risk of bone fracture, and delivered the drug just as effectively as daily injections.

However, the same issues that raised concerns in animal studies were also observed in the women: the formation of fibrous collagen-based tissue around the microchip.

The presence of the tissue had raised concerns among researchers over its potential to interrupt drug delivery, though no such problems were observed in the one-year study, after which the women had the chips removed.

Lead author Robert Farra, president and chief operating officer at MicroCHIPS, which was founded by some of the researchers and licensed the microchip technology from MIT, said the device is best suited for potent drugs needed in small but regular doses.

"For the 200 million people worldwide with osteoporosis, and for patients with many other diseases, taking a daily injection is not an appealing way to take every day for a chronic disease that you may face for the rest of your life."

No adverse events were observed in the patients in the study, though one had a device implanted that malfunctioned and did not release the drugs. Farra told reporters that diagnostic changes have been made to prevent such problems in the future.

He added that the cost was likely to be $10,000-$12,000 per year, comparable to the current costs of administering the osteoporosis drug that the team tested.

Scientists plan to continue studies on the microchip delivery system in heart disease, multiple sclerosis, cancer and chronic pain. The device is likely about five years away from potential market approval, the authors said.

The technology was first envisioned about 15 years ago, and according to an accompanying editorial in the journal by John Watson, a professor of bioengineering at the University of California, many questions still remain.

Among them, how reliable and durable the chip may be over time, and how it may be adapted to other diseases -- a process he likened to a meandering path with many sharp turns.

"For Farra, Langer, and colleagues, the 'hairpin' road to the clinic might be long and winding, but a versatile implantable device that exploits the microchip approach for controlled drug delivery will be well worth the wait for patients with chronic diseases," Watson wrote.

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Microchip delivers drug; can it replace shots?

CHICAGO (Reuters) - An implantable, wireless microchip delivered osteoporosis medicine to a small group of Danish women, raising hope for a new kind of drug delivery device that might allow patients to skip regular injections, U.S. researchers said on Thursday.

The device, now being developed by privately held Microchips Inc, has a wireless receiver that signals the microchip to release the drug.

"Until now, you never had any way you could do this," said Dr. Robert Langer of the Massachusetts Institutes of Technology, who helped to develop the technology and is a board member of Microchips Inc.

Langer said the device could be used for different types of injectable drugs where getting people to take their medications regularly is a problem.

That is often the case in patients with severe osteoporosis, who tend to skip doses of their medications because they cannot tell whether or not the injections are affecting the density of their bones.

That is something the microchip was designed to overcome, said Robert Farra of Massachusetts-based Microchips, which paid for the study. Farra, Langer and colleagues published a paper on the study in Science Translational Medicine.

Instead of constantly releasing small amounts of drug, like most drug-delivery systems, the microchip releases medication on command all at once, much like an injection would.

It can be activated by telephone or computer using a special radiofrequency reserved for medical use to safeguard against accidental release of the drug, Langer said.

GOLD NANOPARTICLES

The microchip itself is a thin wafer, about the size of a small coin, made with tiny wells that hold concentrated doses of medication. These doses are covered with a layer of gold nanoparticles, which dissolve when exposed to a certain radiofrequency. The wafer is implanted under the skin with a receiver device that is roughly the size of a heart pacemaker, Langer said.

In the system's first test in people, the team implanted the device in eight Danish women aged 65 to 70 with a severe form of osteoporosis which required injections of Eli Lilly & Co's hormone treatment teriparatide.

The researchers sent daily signals to the microchip device to release the drug for up to 20 doses. Then, they followed up with a period in which the women took hormone injections.

As seen in animal studies, a fibrous collagen-based membrane developed around the device, but the drug still performed just as well as daily injections in the women, improving bone formation and reducing the risk of fractures, the researchers said.

Still, there were some hitches.

John Watson, a professor of bioengineering at the University of California, San Diego, said in an editorial the device failed to work in one of the patients, and that data was not included in the analysis.

And the team had some manufacturing issues and was able to manufacture only one device with all 20 reservoirs filled with the study drug. Even so, all doses in the microchips were released in the patients, a sign that the device could work in people, Watson said.

"Several years are still needed to bring this technology to approval by the U.S. Food and Drug Administration and to the clinical promise reflected in this small study," Watson wrote.

The current device holds only 20 doses, but Langer said the group is working on adding more doses to the device.

The company hopes to have a version of the device on the market in five years. Langer said he sees potential for other uses, such as treating diabetes or delivering cancer drugs.

SOURCE: http://bit.ly/xUUOwu Science Translational Medicine, February 16, 2012.

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Remote-controlled chip implant delivers bone drug

WASHINGTON (AP) — Medication via remote-control instead of a shot? Scientists implanted microchips in seven women that did just that, oozing out the right dose of a bone-strengthening drug once a day without them even noticing.

Implanted medicine is a hot field, aiming to help patients better stick to their meds and to deliver those drugs straight to the body part that needs them.

But Thursday's study is believed the first attempt at using a wirelessly controlled drug chip in people. If this early-stage testing eventually pans out, the idea is that doctors one day might program dose changes from afar with the push of a button, or time them for when the patient is sleeping to minimize side effects.

The implant initially is being studied to treat severe bone-thinning osteoporosis. But it could be filled with other types of medication, said co-inventor Robert Langer of the Massachusetts Institute of Technology.

"It's like 'Star Trek,'" said Langer, who co-authored the study appearing Thursday in the journal Science Translational Medicine. "Just send a signal over a special radio wave, and out comes the drug."

Today's medication implants continuously emit their drugs until they run dry. One example is a dime-sized wafer that oozes chemotherapy directly onto the site of a surgically removed brain tumor, targeting any remaining cancer cells. Another is a contraceptive rod that is implanted in the arm and releases hormones to prevent pregnancy.

A next step would be more sophisticated implants that release one dose at a time, programmable to skip or add a dose as needed, said biomedical engineer Ellis Meng of the University of Southern California. Meng wasn't involved with the MIT study but also is developing this kind of technology, and called Thursday's report "an important milestone."

Women with severe osteoporosis sometimes are prescribed daily injections of the bone-building drug teriparatide, known by the brand Forteo. But many quit taking it because of the hassle of the shots.

In the study, the microchip held doses of that drug inside tiny wells that are sealed shut with a nano-thin layer of gold. Sending a wireless signal causes the gold on an individual well to dissolve, allowing that dose to diffuse into the bloodstream, Langer explained.

In a doctor's-office procedure, the microchip was implanted just below the waistline into eight women with osteoporosis in Denmark. Testing found one microchip wasn't responding to the signals. The other seven women had their implants programmed to automatically emit a once-a-day dose beginning eight weeks later.

The chips could have begun working right away, said Robert Farra, CEO of MicroCHIPS Inc., a Massachusetts company that has licensed the device and funded the study. But animal research showed a scar tissue-like membrane forms around the pacemaker-sized implant. So he waited until that blockage formed to signal the first of 20 once-a-day doses to begin, to see if the drug could get through.

Blood testing showed the implant delivered the drug as effectively as the women's usual daily injections, and the device appeared to be safe, the researchers reported.

It will take large-scale studies to prove the implant works as well as the long-used shots, cautioned osteoporosis specialist Dr. Ethel Siris of New York-Presbyterian Hospital/Columbia University.

"They're a long way from proving that this mode of administration is going to work," she said. But it's an intriguing idea because "it's daunting to have to take a daily shot."

Farra said his company hopes to begin a larger-scale test, using a chip that can hold 365 doses, in 2014. While doses of this osteoporosis medicine typically aren't adjusted, he said, the eventual goal is for patients to carry a cell phone-sized device that would provide wireless feedback to the doctor who programs their implants.

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Microchip successfully delivers bone-loss drug: study

A microchip inserted under the skin has been shown for the first time to successfully deliver a bone-loss drug to a small sample of women, according to US-led research published Thursday.

The device may someday allow patients to avoid daily injections of medication and permit doctors to adjust their doses from afar, said the study which appears in the journal Science Translational Medicine.

"We hope this really is the dawn of a whole new way of thinking about delivering medications," said co-author Robert Langer, a professor of cancer research at the Massachusetts Institute of Technology.

Langer and colleagues presented their findings at the annual meeting of the American Association for the Advancement of Science in Vancouver, Canada. Langer addressed the conference by phone.

The device is about the size of a pacemaker, or a computer flash stick, and contains daily doses of medication inside small wells that open up either on a predetermined schedule, or when the chip is given a wireless signal to release the drugs.

Each well is covered by a nano-thin layer of gold which protects the drug and prevents it from being released.

The wireless signal causes the gold to dissolve and allows the drug to enter the bloodstream.

In this case, researchers tested the device on seven women aged 65-70 in Denmark who were prescribed the drug teriparatide for osteoporosis. The microchip was implanted just below their waistlines.

After tracking the women for 12 months, researchers found that the treatment improved bone formation and reduced the risk of bone fracture, and delivered the drug just as effectively as daily injections.

However, the same issues that raised concerns in animal studies were also observed in the women: the formation of fibrous collagen-based tissue around the microchip.

The presence of the tissue had raised concerns among researchers over its potential to interrupt drug delivery, though no such problems were observed in the one-year study, after which the women had the chips removed.

Lead author Robert Farra, president and chief operating officer at MicroCHIPS, which was founded by some of the researchers and licensed the microchip technology from MIT, said the device is best suited for potent drugs needed in small but regular doses.

"For the 200 million people worldwide with osteoporosis, and for patients with many other diseases, taking a daily injection is not an appealing way to take every day for a chronic disease that you may face for the rest of your life."

No adverse events were observed in the patients in the study, though one had a device implanted that malfunctioned and did not release the drugs. Farra told reporters that diagnostic changes have been made to prevent such problems in the future.

He added that the cost was likely to be $10,000-$12,000 per year, comparable to the current costs of administering the osteoporosis drug that the team tested.

Scientists plan to continue studies on the microchip delivery system in heart disease, multiple sclerosis, cancer and chronic pain. The device is likely about five years away from potential market approval, the authors said.

The technology was first envisioned about 15 years ago, and according to an accompanying editorial in the journal by John Watson, a professor of bioengineering at the University of California, many questions still remain.

Among them, how reliable and durable the chip may be over time, and how it may be adapted to other diseases -- a process he likened to a meandering path with many sharp turns.

"For Farra, Langer, and colleagues, the 'hairpin' road to the clinic might be long and winding, but a versatile implantable device that exploits the microchip approach for controlled drug delivery will be well worth the wait for patients with chronic diseases," Watson wrote.

View the original article here