Pharmaceutical Trials Under Way in Iowa, NCGA Notes (6-21-05)
National
Corn Growers Association (NCGA) Biotech Working Group member Bill Horan
is taking part in a bold initiative under way in Iowa that could give
growers another market for corn and hope to individuals battling diseases
and other illnesses. Horan is monitoring a field trial for plant-made
pharmaceuticals (PMP).
Iowa State University scientists received permission
from state officials to plant a trial field of pharmaceutical corn
at the Iowa Army Ammunition Plant near Middletown. The crop on the
Army base is being grown to create a vaccine that prevents diarrhea
in pigs, and possibly traveler’s diarrhea in humans. The U.S.
military would be important beneficiaries of this type of vaccine
because they could be called to duty in another country at any time.
“It’s important to solve a prominent problem
for livestock farmers whose herds have scours,” Horan said.
“It’s more important to use the corn plant for therapeutic
purposes that will keep our military safe and doing their job.”
Horan said the vaccine is working in initial clinical
trials. Mice and rats have been given diarrhea and then the vaccine.
After the diarrhea was cured, scientists gave the animals diarrhea
again. The mice and rats did not develop diarrhea the second time.
Scientists and biotechnology companies have focused
on PMPs as an inexpensive way to manufacture drugs. This is the first
field trial in Iowa since 2002 when such biotech crops were halted
because ProdiGene, Inc. was found mismanaging tests in Iowa and Nebraska.
Scientists insert protein sequences into the genetic makeup of
a plant. Once there, the plant becomes the factory, manufacturing
proteins for pharmaceutical use. When the crop is harvested, the therapeutic
proteins are extracted, refined and used in pharmaceutical production.
Possible uses include blood proteins, enzymes and monoclonal antibodies.
Plants are one of the better vehicles for a drug to
develop in. Corn’s genome is well known, and researchers have
experience with biotech corn. In addition, the production costs required
to grow PMPs are low, which significantly reduce the overall cost
of drug production. As a result, the drug costs less for consumers.
“The NCGA supports new uses of corn,”
said NCGA’s Nathan Fields, manager of research and business
development. “We’re focusing on maintaining a safe crop
until significant testing is accomplished. We support all regulations
concerning pharmaceutical crops, and we’re willing to work with
all agencies to ensure the safe production of pharmaceuticals in plants.”
Two trial plots have been planted, each approximately
one-tenth of an acre. Each plot will be under 24-hour surveillance
and pollinated and harvested by hand. Horan said he and the scientists
are taking extra caution with the fields.
For example, the U.S. Department of Agriculture (USDA)
requires the plot reside at least one mile from any other corn field.
The test fields are 1.2 miles from the nearest field. The USDA also
requires a physical barrier around the field. Not only is there a
fence surrounding the site, but the field has an electric fence around
it and it is on an Army base, which has several security fences.
The USDA does not require any planting restrictions.
However, Horan said the team took several measures to ensure the safety
of the corn in the area. The field was planted two months after the
nearest field was planted. People leaving the site must use a foot
scrapper to remove soil from their shoes. The team will detassle and
hand-pollinate the corn as well.
“We’ve gone to extreme protocols on these
plots. Everything from the security of the location to the extreme
control of the material,” Horan said.
“Pharmaceutical corn could be very beneficial
to growers and consumers,” Fields said. “NCGA applauds
the effort that Mr. Horan and Iowa State University are putting into
this project. We know that they are taking every possible measure
to ensure the corn is grown safely and under strict guidelines.”
In the past, Horan helped grow a corn crop used for
cystic fibrosis drug trials. He said the response from families with
children who have the disease let him know he was making a good decision
to get into the industry.
“We’ve received letters from families
of children with cystic fibrosis, and they’re heart-wrenching
letters,” Horan said. “They tell us they’re praying
for us.”
Horan added: “There’s a certain satisfaction
for farmers to produce food to feed people. When corn is used to provide
relief for children with terminal diseases, it’s even more satisfying.”
There are 350 to 400 drugs ready for pharmaceutical
corn, Horan said, adding researchers have just scratched the surface
of what’s possible.
“Biotech plants are not for every farmer. But
the spinoff for opportunities will affect everyone, farmers and nonfarmers,”
Horan said.