testing diabetes remedy
The company has raised money to expand
tests of its treatment that could make insulin shots unnecessary.
By DAVID RANII, Staff Writer
RALEIGH -- A fledgling
biotechnology company has raised $5 million to expand testing of what it
hopes will some day become a revolutionary treatment for diabetes, eliminating
the need for insulin shots.
Encelle Inc.'s bioartificial
pancreas has functioned successfully in diabetic dogs and rabbits for up
to four months. Bioartificial means using living cells from a source other
than the patient; in this case, the company's Encellin XP uses cells from
a pig's pancreas to produce insulin.
Encelle, which has its one-man
headquarters in Raleigh and its 19-person scientific operations in Greenville,
received a total of $4.5 million in venture-capital financing last week.
It also expects to close on another $500,000 from private investors next
The venture-capital funds participating in
the funding include: Intersouth Partners of Morrisville; Cordova Ventures
of Atlanta; the N.C. Bioscience Investment Fund managed by Durham's Eno
River Capital; and the Raleigh-based N.C. Enterprise Fund. All are new
investors, with the exception of N.C. Enterprise, which participated in
the nearly $6 million in first-round financing Encelle raised.
Scientists have been trying to produce a bioartificial
pancreas for years, without success, to aid diabetics. The problem is that
when a person or animal dies, their pancreas releases enzymes that quickly
begin to digest the pancreas itself. In addition to creating a roadblock
to creating a bioartificial pancreas, that process explains why very few
human pancreases are transplanted each year.
But Anton-Lewis Usala, a physician who is
founder and chief technical officer, has blazed a new path. Usala is a
former head of the pediatric endocrinology section at East Carolina University
School of Medicine. He incorporated Encelle in 1991, but
it was a part-time endeavor until he and three colleagues left ECU in 1996.
"Anton has approached this from a totally
fresh point of view," says Jim Woodward, a veteran of biotechnology start-ups
and the company's president and chief executive officer. "There is nothing
we do that is conventional, technologically."
Encelle uses a proprietary process
to mechanically separate the tissues of a swine pancreas. Then it injects
an artificial connective substance, called a hydrogel matrix, that enables
storage of the insulin-producing cells at low temperatures without degrading
them. Others haven't been able to do this, according to Usala, because
as water cools it expands and damages the pancreatic tissue.
"We've kept pancreatic tissue alive for two
years in a refrigerator," he says. "No one else can keep it alive for 14
Second, in order to transplant these swine
cells into a patient's pancreas, Encelle needed a way to
prevent the human immune system from recognizing the cells and attacking
them. Encelle believes it has accomplished this by coating
the cells with a patented, microscopically thin, permeable polymer coating
that prevents the immune system from binding with the swine cells.
The ultimate goal for Encelle
is to enable patients to avoid insulin injections altogether. But in the
short term it is more likely that the company's first Encellin XPs would
let diabetics get by with just one shot of low-dose insulin daily, rather
than the multiple shots many diabetics face today.
"If this works, and be sure you underline
and bold[face] that 'if,' this is going to be a new form of medical therapy,"
In addition to having what Usala calls "a
profound impact on the quality of life" of diabetics, it also could have
a tremendous impact on health-care expenditures.
There are more than 1 million insulin-dependent
diabetics in the United States, and $1 of every $7 in health-care expenditures
is diabetes-related, according to Encelle. The reason: the
vast majority of diabetes patients suffer from complications including
amputation, blindness, kidney failure and coronary artery disease.
Usala himself has been a diabetic since infancy,
and that has been a powerful motivating force for him.
The big if, of course, is whether the Encellin
XP will work in humans.
But before Encelle reaches that
hurdle, the Encellin XP needs to be tested in dozens more diabetic animals.
If those tests go well, Encelle expects to submit an application
to test the product in humans to the Food and Drug Administration in the
second half of 1999.