Aurogen exists solely to develop Doug's patented IGF technology into actual treatments for diabetic neuropathy and brain disorders. Doug won't disclose how much money has been invested in the company, saying it could put him at a competitive disadvantage, but he will reveal that funding is provided by "high-net-worth individuals" from the greater Fort Collins area who have prior relationships with the company's boardmembers.
Thus far, his biggest challenge, paid for with a Colorado Commission on Higher Education grant, has been figuring out a way to mass-produce the IGF protein. "The normal method of manufacture by production in bacteria, for example, is just too expensive, and more than that, there's probably insufficient manufacturing capacity in the world to make enough IGFs to treat the millions and millions of patients with Alzheimer's disease. Therefore, we're beginning an initiative to construct the human IGF gene and to insert that gene into rice plants."
Mark Manger
Doug and Wendy Ishii are joined by science and art.
A star is born: Doug Ishii started his childhood in a San
Francisco housing project.
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Biotech companies looking for less expensive means of manufacturing new drugs have turned toward genetically engineered crops in recent years, since plants such as rice and corn have the ability to mass-produce human proteins when part of their genetic code is replaced with a human gene. In fact, Ventria Bioscience, the company Aurogen has partnered with for its IGF endeavor, has already had success growing human proteins in rice. The small, eighteen-employee biotech company out of Sacramento has made headlines in the New York Times, Business Week and the Associated Press for the promise of its technology, but also because of the controversy it presents. Its CEO, Scott Deeter, lives in Fort Collins and is the former president of CyberCrop, a Fort Collins-based software company.
Ventria is developing a drug using two human proteins found in mother's milk, saliva and tears that can lessen the severity and duration of diarrhea, a top killer of children in developing countries. Despite the drug's potential, some environmentalists and farmers fear Ventria's rice could mix with conventional crops and threaten food safety. Even the perception of such a possibility could scare off overseas customers, who account for 50 percent of the rice industry's $1.18 billion in annual sales, according to the Associated Press. Japan, a major exporter, is particularly wary of genetically engineered crops.
The company has insisted that it's highly unlikely that their rice could cross breed with other crops because rice pollinates itself, and the protein is extracted before it leaves the farm, but groups like the Union of Concerned Scientists have argued that there is no way to completely eliminate the risk of contamination. "There are lots of places in the production chain where things can be contaminated," says Karen Perry Stillerman, a senior analyst with the UCS's food and environment program. Thus, the UCS wants the USDA to ban all production of human proteins in food crops grown outdoors.
Stillerman doesn't believe such a ban would come at the expense of patients or slow the development of drugs, because despite fifteen years of testing, no company has ever received FDA approval for a single drug grown in food crops, she says.
Founded in 1997, Ventria first planted rice fields in California but faced mounting opposition from environmental groups and ceased its farming experiments there. Last year the company abandoned plans to plant in Missouri's rice belt after Anheuser-Busch threatened to boycott Missouri-grown rice. Ventria has since started growing its rice in North Carolina, with USDA approval to expand the operation to 335 acres -- and just last month the company was offered $2 million in incentives to build a processing plant in Kansas after the financing to build at Northwest Missouri State University fell through.
For now, Doug's rice is still growing in a lab in California, but he estimates that enough IGFs for the first phase of clinical trials could be grown on two or three acres of land. "That may be done almost anywhere," he says. "It may be done in Missouri. It may be done in South America. We don't yet know if the IGF is going to be produced in the rice kernels, and we can't know that until the plants mature and the rice grains are produced, and that will happen this fall, so we're on pins and needles."
If it works, Doug still needs millions before trials, and getting that far doesn't guarantee a positive outcome or a new drug. There are thousands of small biotech companies like his around the country, each with their success riding on just one or two products. Except for those few that get a positive clinical trial, most of the companies will fizzle and die.
As Doug points out, "You don't get any points for being second in science."
