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2 firms take crack at pig transplants
Naomi Aoki, Boston Globe Monday, May 14, 2001

Two biotech companies have formed a partnership to clone genetically
modified pigs as a way of harvesting tissue and organs for human transplants.

Immerge BioTherapeutics and Ifigen Inc. hope to rid pigs of the enzymes
that trigger violent immune reactions in humans and the viruses that might
cause disease, creating a safe source of organs for the thousands of people
waiting for hearts, livers and kidneys.

Infigen Inc. of Wisconsin is one of only a few groups worldwide to have
successfully cloned piglets. And earlier this year, it became the first
company to clone a transgenic pig, said Julia Greenstein, president and
chief executive of Immerge BioTherapeutics of Massachusetts.

Although creating a transgenic pig is a type of genetic modification, it
uses a different process from the one the companies will need to knock
out the genes responsible for causing problem viruses and enzymes.
No such "knock-out" pig has ever been cloned. "Each step is more difficult
than the last," Greenstein said. "But we've picked the leader in this
technology."

For nearly two decades, scientists have been studying pigs as a potential
source of organs to replace those that are failing in humans. Surprisingly,
pigs are biologically similar to humans and carry fewer deadly diseases than
primates.

But the research has been riddled with setbacks, prompting some companies
to abandon the field, known as xenotransplantation. Scientists still grapple
with how to prevent the human body from rejecting animal tissue and ensure
the organs don't transmit disease. "Xenotransplantation has been on the
ropes for a while," said Michael Ehrenreich, president of Techvest LLC.

Despite the scientific hurdles, Greenstein is optimistic that the companies
will achieve their goal within three years, paving the way for Immerge Bio
Therapeutics to test the pig organs in primates and eventually humans.

The financial terms of the deal were not disclosed. The companies will
receive a $1.7 million grant from the Commerce Department's National
Institute for Science and Technology. And Immerge will pay Infigen
licensing fees and
research money for three years, as well as milestone
payments.

Immerge was formed last year as a joint venture between BioTransplant Inc.
of Charlestown, Mass., and Novartis Pharmaceuticals to commercialize pig
organs for human transplants. Novartis promised to provide $30 million over
three years to the venture.

BioTransplant began creating a highly inbred species of miniature swine
nearly a decade ago to create a pool of potential organs as genetically
similar as possible. The pigs, which weigh about 250 pounds each, were
screened for more than two dozen viruses and infectious diseases.

The joint venture's goal is to start testing pig organs in humans in 2004.
Such testing, and later commercial transplants, would require approval
from the U.S. Food and Drug Administration.

In addition to breeding or cloning pigs, Immerge also is working on ways to
prevent people from rejecting pig tissue and organs by re-educating the
immune system and increasing the body's tolerance for foreign cells.

More than 75,000 people nationwide are on waiting lists for organs,
and thousands die each year while they wait.

"That overwhelming need is what continues to drive our interest in
xenotransplantation," Greenstein said.

http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/05/14/BU201231.DTL&type=business

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