A Route 1-based biotech company has a product it says could save the pharmaceutical industry billions of dollars, reduce animal testing, and help ensure faulty drugs don’t go to market.

Hurel, which is headquartered in Beverly Hills with labs in North Brunswick, has developed liver cell cultures that researchers can use to simulate the effects of drugs on real human, rat, or dog livers. These laboratory-dish stand-ins could save a lot of time and money in research, and could show whether a drug is toxic before scientists inject it into animal test subjects. The company name stands for “human relevant.”

Hurel recently completed a test of its product using a long-discontinued drug called Troglitazone. Company CEO Robert Freedman says this test shows how a tiny batch of cells made by Hurel could save hundreds of millions of dollars for a giant pharmaceutical company.

Troglitazone was an anti-diabetic drug developed by Japanese company Daiichi Sankyo in Japan and marketed in the United States by drugmaker Parke-Davis/Warner Lambert under the trade name Romozin. It was approved by the FDA in 1997, and reached the market in March of that year. In 2000 the FDA withdrew the drug from the market after people who took the drug suffered liver failure. At least 63 people died of liver failure caused by taking troglitazone.

In addition to the human lives lost, the debacle took a heavy toll on Parke-Davis’ finances. Freedman estimates the company lost about half a billion dollars by withdrawing the drug from the market, and in the lawsuits that followed. This is the scenario that the many years of laborious testing is supposed to avoid.

Freedman says his company, working with multinational drug company Sanofi, showed that if Troglitazone had been tested on Hurel’s cells, the tests would have shown that it was toxic to the human liver. In theory, the company could have abandoned research on Troglitazone before it ever reached the expensive clinical testing stage, saving hundreds of millions of dollars and many lives. Hurel presented its results on March 19 at the Society of Toxicology’s annual meeting.

“Nobody can say whether a particular piece of data like that could have changed the FDA’s mind,” Freedman says. “But I think you can safely say they would have taken it into careful consideration.” Freedman says Hurel’s system simulates the human liver, as well as that of dogs, rats, and canomulgus monkeys. These are the most commonly used animals in drug testing. Hurel’s tests showed that the drug was far more toxic to humans than it was to dogs and rats.

Another advantage of Hurel’s platform, Freedman says, is its long lifespan of 14 days. Although drugs are often tested on cell cultures, few last as long as Hurel’s liver cells, which allows the cell cultures to find effects that take several days to take hold.

If a person ingests a toxic substance, the organ most likely to be damaged is the liver, followed by the heart and the kidneys, Freedman says. Thus, the focus of Hurel’s products are on the liver.

However, the company is currently developing another product that promises to be even more useful to the drug industry. Many cell cultures are tested in petri dishes. In the body of an organism, organs are nourished by blood, which brings oxygen and nutrients and takes away waste.

Because scientists have yet to create any sort of artificial blood, the best they can do is a nutrient bath. This allows organ tissue to survive for a while, but limits the usefulness of the tissue as an analog for a real organ. Hurel is seeking to improve upon this technique with microfluidic platforms that mimic the circulatory system. Tiny pumps wash the nutrient bath over the cell tissue, which allows the cells to dispose of waste, and it also provides more oxygen than the traditional method. The flow can carry molecules from one cell to another. By putting liver cells and heart cells in the same platform, Hurel was able to pass liquid over the liver, then to heart cells, simulating what would happen when the liver processed a drug.

In the case of Troglitazone, this revealed that the liver was breaking down the drug into harmful toxins. “It was a metabolite in Troglitazone that did the damage,” Freedman said. “And that’s totally common.”

The next generation of Hurel products will be a line of microflow platforms, each with two cell cultures. Hurel will ship the complete kit directly to the labs of its customers, allowing them to start their experiments right away.

Freedman is not only the CEO of Hurel, he is one of the co-founders. He owes the existence of the company to his wife skipping an alumni event. Freedman’s wife, Joan, is a clinical psychologist and graduate of Cornell. “I went to an alumni event a number of years ago in her stead, and I saw the technology presented,” Freedman recalls. “I immediately saw its implications and its potential value, and I thought I could help develop it.”

The Cornell scientists who developed it thought the same thing, and Hurel was incorporated in 2005. Freedman, who lives in California, always intended Hurel to be a West-coast tech company. But very early on, the pharmaceutical industry had other ideas.

“When I began to show the technology to pharmaceutical companies, a number of them very quickly showed interest and invited me to incubate a company on their premises,” Freedman says. In its first year, Hurel was housed at Janssen Pharmaceuticals at Johnson & Johnson. Freedman had to remain in California for personal reasons, but did not hesitate to put his lab a continent away.

“There was no way I was not going to follow the dictum of `stay close to the customer,’” he says. “And so my life in airplanes began.”

Hurel was born as a two-coast company. Today it has fewer than 20 employees between the two offices, but is growing. Freedman stays in touch with the New Jersey operation by frequent travel, using the Internet, and by keeping East Coast hours (he was interviewed by U.S. 1 at 5:30 a.m. Pacific time.)

In 2007 the company was funded by the Schering-Plough Research Institute, which is now part of Merck, and was incubated in Schering’s Kenilworth labs. In 2011 Hurel struck out on its own. The lead investor is Spring Mountain Capital. Other investors include Freedman, and the Humane Society of the United States, which hopes Hurel’s work will lead to less animal testing of drugs.

Freedman grew up in Massachusetts, where his father was a wool and synthetic fiber merchant in the old Boston wool trade. His mother was a social worker. Together, they encouraged Freedman to be an intellectual entrepreneur. Freedman attended MIT for his undergraduate work, studying architecture and neurophysiology. After graduation, he began a career as a documentary filmmaker, helping create the award-winning PBS series “Vietnam: A Television History” as well as a number of health and medicine-related programs.

Later, Freedman went back to school, earning a master’s in public policy from Harvard’s Kennedy School, and an MBA from Harvard Business School. He has worked at various times as a venture capitalist, an investment banker, and a private company CEO. In the executive role, he was known as a turnaround specialist, taking the helm of troubled oil company Huntway Refining before its sale to Valero.

And although Freedman appreciates the technology behind his company, his point of view as a businessman leads him to see it as a product first and foremost.

“When you take away all the tech glamor and the bedazzlement of it, you get down to the basic fact that we are here to serve the customer just like any industry,” he says. And what his customers want is to reduce the immense, company-killing risk of drug development. “If you could more reliably detect toxicity first in the liver, second in the heart, and third in the kidney, you would be knocking the rate of failed late-stage trials way down,” he says.

Hurel Corp., 675 Route 1 South, Technology Center of NJ, North Brunswick 08902; 732-626-5596; fax, 732-745-7270. Robert Freedman, CEO. www.hurelcorp.com

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