Atlanta Business Chronicle, GA

From the November 8, 2002 print edition

BresaGen moves slowly to grow stem cell work

Julie Bryant  Staff Writer

The door leading to the headquarters of BresaGen Inc.
opens with a quiet shoosh. Inside, a simple paper sign
asks visitors to wait for the receptionist before stepping
further into the Athens-based company's unassuming
home office.

There is little indication that mere feet away lies
a controversial stockpile of tiny human cells,
plucked from human embryos, that could hold the key
to new treatments for a host of fatal diseases
and disabling conditions, including Parkinson's,
diabetes and spinal cord injuries.

And while a raging Capitol Hill ethics debate over
the collection, study and funding of those cells would
lead observers to believe that there is wild demand
for unfettered access to them, most of BresaGen's
stash still lies undisturbed on a refrigerated shelf.

There are no scientists dashing down corridors,
no Amazon.com-style order filling and no Fed-Ex
trucks barreling down the driveway to BresaGen's
front door.

In fact, there has been little more than a neatly
controlled fuss over the company's stem cells.

We've had inquiries from about 80 different
organizations, but only filled a few orders,"
said BresaGen CEO John Smeaton, who, last year,
brought the company's stem cell division to Athens
from Australia, where BresaGen has its original
headquarters.

Even nationally there has been slow-to-burn interest
in the federally funded stem cell collections now held
by 14 different entities across the globe, including
BresaGen's.

The tame, but mounting, demand comes despite
the fact that scientists regard stem cells as the
building blocks of all human life, the "big bang"
material that gives rise to a human being — and the
foundation for a paradigm shift in medicine.

Stem cells, by definition, are blank-slate cells that can
turn into just about any type of cell found in the body,
such as a liver cell, brain cell, skin cell, even a blood
cell. In theory, scientists could use stem cells
to replace or restore damaged cells in the body — a
theory that has left even the most seasoned researcher
all a-quiver.

So why the controversy over stem cells?
And why the limit on federal funding?

Stem cells are an especially touchy subject for
the government because they are derived from human
embryos — embryos that had to be destroyed before
the cells could be extracted.

In funding stem cell research, the government
is headed down the proverbial slippery slope,
said Douglas Johnson, federal legislative director
for the National Right to Life Committee,
in a recent interview.

Typically, but not in all cases, the embryos are
collected from fertility clinics, which discard embryos
deemed unsuitable for implantation. The stem cells
are extracted from the discarded embryos.
Each embryo's stem cells give rise to a stem cell line.

Very simply put, scientists peer through microscopes
at a tiny days-old mass of cells that forms the embryo
and see, well, cells. Religious groups, on the other
hand, say they see a miniature human being deserving
of federal protection.

Recently the Bush administration revised its stance
on the safety of research volunteers, stating that
embryos used in experiments are to be regarded
as human subjects whose welfare should be
considered along with that of fetuses — which are
more developed than embryos — children and adults.

To maneuver around the stem cell controversy,
President George W. Bush set down a strict set
of criteria for stem cell funding. Federal funds
are used only for embryonic stem cell lines
that existed prior to Aug. 9, 2001.

The stem cells also had to be derived from embryos
created for reproductive purposes and were no longer
needed for those purposes. Informed consent must
have been obtained for the donation of the embryos
and there must have been no financial inducements
given for the donation of the embryo.

Those strict requirements have stirred the ire
of the researchers, who say the Bush criteria will
significantly hinder the medical advances that can
be made using stem cells.

And what advances they say can be made:
The theory behind stem cell research has raised
hopes that scientists might one day be able to
restore a stroke victim's ability to function normally
 — or even grow teeth in a petri dish
and help the paralyzed walk.

Meantime, political debate has stymied an all-out
land run on stem cells and, for now, the science
is only trudging along.

Slow interest aside, it has been an exhilarating year
for BresaGen, which found itself rapidly shedding
its modest, university-based biotech-startup image
as the company was pushed onto a global stage,
taking its place alongside a highly select group
of peers.

A select group

Shortly after Bush announced his decision to allow
a limited sum of federal dollars to be used to fund
some stem cell research, nearly a dozen entities,
including BresaGen, were quickly identified as
having eligible cell lines. Three more entities
would join the group later.

"Bush made his announcement and all hell
broke loose," Smeaton said. Reporters suddenly
descended. There was even a CNN truck parked
just outside, Smeaton recalls.

All the fanfare came after BresaGen was caught
quite by surprise by a call from the National
Institutes of Health (NIH), the research arm
of the U.S. Department of Health and Human
Services, just one month earlier, Smeaton said.

That call later developed into confirmation that
BresaGen would claim a spot beside the other
companies, universities and laboratories identified
as having a combined total of 64 eligible stem cell
lines. That number is now up to 78.

Abruptly, BresaGen became part of the centerpiece
for a monster of a national debate.

Then 9/11 happened and, just as abruptly,
the reporters scattered and the corridors were
quiet again, Smeaton said.

Now, a little more than a year later, the trickle
of orders at BresaGen is somewhat surprising.
The company is, after all, one of the only
14 entities worldwide with eligible stem cell lines.
BresaGen also is one of an even smaller number
of the funded entities actually able to widely
distribute its stem cells.

As of September, only three of the 14 entities
listed on the NIH registry were actually
distributing cells to researchers,
said Della M. Hann, an NIH senior policy adviser
in the Office of the Deputy Director
for Extramural Research. BresaGen joined those
three in October.

And of the 78 approved cell lines, only about
a half-dozen are being used.

Smeaton, however, is less than shocked.
Stem cell orders have reportedly been coming in
at a fairly steady clip at some of the other funded
labs that began distributing cells earlier than
BresaGen, including at Australia-based ES Cell
International and WiCell Research Institute,
a subsidiary of the Wisconsin Alumni Research
Foundation, which holds a patent on stem cells.

And many labs are simply not yet ready to receive
stem cells, which can be tricky to grow,
Smeaton said.

Add to that the controversy. Folks from both sides
of the ethical debate have continually raised
the subject of using adult stem cells, which,
many say, can accomplish what embryonic
stem cells can, minus the wrangling. Scientists
disagree.

There are even questions as to whether the
stem cell lines being funded now will ever
give rise to products that could pass
U.S. Food and Drug Administration (FDA)
standards, according to researchers.

The existing stem cell lines were grown using
mouse feeder cells, a common lab technique
that allows human cells to grow on top of mouse
cells, which aid, or feed, cell growth — but it is a
technique that has rendered the current cell stash
essentially contaminated,
said BresaGen's Smeaton.

To top it off, scientists really aren't sure if stem cell
research actually will lead to blockbuster cures
and disease treatments. Troubling doubts have
dimmed prospects for a flood of private-sector
funding, making researchers that much more
dependent on the rather gun-shy government
officials who control federal purse strings.

And there surely will be patent squabbles over
any future products made using stem cells.

There is more hype in stem cell research
than in anything outside professional wrestling,
said Richard Garr, CEO of a Maryland-based
stem cell company, NeuralStem Inc.

"What we have is the wheel," said Arlene Y. Chiu,
a program director at the National Institute
of Neurological Disorders and Stroke, referring
to stem cells. "It's a starting point."

Scientists must still develop the rubber
and the gears to get to the car.

But BresaGen has faced these challenges calmly.

To date, BresaGen has secured $1.6 million
in federal stem cell grant money, signed a tangle
of required licensing and distribution agreements
with the National Institutes of Health and made
little vials of its prized stem cells available
to other researchers for $5,000 a pop — a price
recommended by the NIH.

Trying to cure Parkinson's

One of those vials recently made its way to the lab
of one of the country's most preeminent stem cell
researchers, Ronald D.G. McKay,
chief of the molecular biology lab at the
National Institutes of Health's National Institute
of Neurological Disorders and Stroke,
according to Smeaton.

There McKay is experimenting on neural stem cells
in hopes that one type of cell in particular might
give rise to a new treatment for Parkinson's.

"Embryonic stem cells quite clearly give rise to
[dopamine-producing] neurons," said McKay,
speaking recently before a group of journalists
assembled at the NIH as part of a Knight Center
for Specialized Journalism fellowship program
on stem cells.

It is those dopamine-producing cells that conk out
in the brains of Parkinson's patients, scientists
believe. If new cells could be transplanted into
the region where those cells have died, symptoms
of the disease could be alleviated. Indeed, stem cell
studies in mice afflicted with Parkinson's have
shown promising results, McKay said.

BresaGen, which also collects revenue from other
lines of work done mostly in Australia, including
animal growth hormone production, is working on
a similar treatment for Parkinson's and also
is looking to tackle spinal cord injuries using
stem cells therapeutically.

But so many things must happen before even human
testing of such therapies can occur. So far only
animal tests have been performed — albeit with
some promising results. And there are so many
questions about stem cells that are still unanswered.

"Our ignorance in this field is monumental,"
said Dr. Marvin C. Gershengorn, a scientific research
director at the National Institute of Diabetes
and Digestive and Kidney Disease.

Reach Bryant at [log in to unmask]

© 2002 American City Business Journals Inc.

SOURCE: Atlanta Business Chronicle, GA
http://atlanta.bizjournals.com/atlanta/stories/2002/11/11/story3.html


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