Drug Delivery by Chip May Be Coming

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Drug Delivery by Chip May Be Coming

Mon May 20, 8:45 AM ET

He isn't there yet, but three years after

attracting attention by demonstrating an

early version of the device in a

laboratory beaker, he insists that his

company, MicroCHIPS, is making progress

and will have a product out in five years.

The company has made the device work in a

lab rat, and because it's a device, not a

drug, Santini says that means it would

almost certainly work in a person as well.

The chip — fingernail-sized, attached to a

battery and wrapped in titanium — would be

inserted just under the skin, likely in

the abdomen. It contains hundreds of tiny

reservoirs which would be filled by a

drug, or several drugs. Software would

instruct the chip when and how much of

each drug to release, automatically and

precisely.

On Monday, the company plans to announce a

second round of venture financing — $16

million Santini claims will carry it into

clinical trials. The other good news:

Santini, 29, has been named one of the top

100 innovators under 35 by the

Massachusetts Institute of Technology

(news - web sites)'s Technology Review

magazine. The winner will be announced

Thursday.

Santini's is a field that requires a mind

for biochemistry, electronics and

engineering. But for him, the inspiration

also came partly from the heart.

Diagnosed at age 12 with lupus, an immune

system disease, he spent several years in

and out of hospitals. He's in remission

now, but he learned that for patients drug

delivery can be as important as the drugs

themselves.

" I learned early on that if you can find

better ways to deliver these drugs,

(reduce) these side effects, it improves

quality of life, " he said.

Before his senior year at the University

of Michigan, Santini spent a summer at MIT

and hooked up with nanotechnology and drug

delivery experts S. Langer and

Cima.

They wanted to build a microchip that

could solve many of the problems of drug

delivery. Their first attempt left room

for improvement.

" It was a really ugly looking device, "

says Santini, sitting in his office

surrounded by sports paraphernalia of his

beloved Detroit teams. " It was a glass

slide with holes drilled in it and lots of

apoxy gooped on it. It didn't work, but it

gave us a lot of confidence it could. "

Santini came to MIT for graduate school,

worked with Langer and Cima, and became

president of MicroCHIPS. Now 21 employees

are tweaking the device, preparing it for

clinical trials in about two years.

The chip works like this: each of the

tiny, drug-filled reservoirs is sealed

with gold, which is virtually corrosion-

proof.

But if surrounded by chloride — found in

the body's natural saltiness — the gold

dissolves when a single-volt current from

the device's battery is run through it.

The gold harmlessly slips into the body

and the drug is released; by subbing a

fluorescent die into the reservoirs one

can watch the process through a

microscope.

Santini says it will be safe; the chip

faces backward in the body and about the

only thing that could shatter it and

release all the drugs would be a bullet.

The technology could make drugs not only

easier to manage, but more effective.

That's because research is veering toward

smaller proteins that focus on particular

tasks and draw less attention from the

immune system. But those molecules are

also more fragile.

" This stuff ... has to be the wave of the

future, " says Doug Munch, a pharmaceutical

and drug delivery consultant in Basking

Ridge, N.J., " because of the control that

may be required for future high-tech drugs

may exceed what you can achieve by giving

these orally and having them chopped up in

the GI (gastro-intestinal) tract. "

Chips also have the advantage of what

economists call a " precommitment device " —

locking patients into a drug regimen they

may be tempted to slip out of. That could

be especially useful for a disease like

Hepatitis C, where the symptoms can be

less unpleasant than the toxic effects of

the treatment.

Obvious candidates are patients suffering

from diabetes, which can require daily

injections, and HIV (news - web

sites)/AIDS (news - web sites), which

requires a complicated daily regimen of

several medications.

But uses for those diseases are far down

the road, Santini says, because insulin

and HIV drugs cannot yet be made in

sufficient concentration to fit in the

reservoirs. For now, the most likely early

uses are for delivering steroids,

hormones, cancer drugs and pain killers.

Santini said he isn't worried about

rivals. MicroCHIPS has partnered with one

pharmaceutical company, whom he declined

to identify. There could be a threat if

such companies decide to push their own

research in the field. Last year, for

instance, & merged with

drug- delivery company ALZA.

Another company, ChipRX, is focusing on

devices equipped with sensors that respond

to the environment — sensing, for

instance, a rise in blood sugar and

triggering a release of insulin.

Some say pre-programming a drug release,

like microCHIPS is doing, is useful, but

creating a device that thinks for itself

is moreso.

" There are two big problems out there, and

if their stuff works, they'll have knocked

off one of them, " said J. Chizeck,

chairman of the electrical engineering

department at the University of Washington

in Seattle and an expert in the field.

" The huge markets and the tremendous

opportunities that are there, like

diabetes, they need a sensor that can stay

in the body. "

Santini says the company plans eventually

to work on incorporating sensors.

" The holy grail of drug delivery has been

to integrate biosensors with drug delivery

systems so they can respond automatically

to changes in the body, " he said. " We will

definitely be heading that way. "