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Can Interthyr be Ohio U’s next commercialization success story?

While there’s plenty of optimism surrounding Interthyr, it’ll be awhile before university officials know what kind of potential they’re sitting on. No human testing of the company’s drug candidate for cancer and autoimmune disorders has occurred yet, and it’s unlikely to happen until 2012.

Ohio University research officials hope drug development spin-off company Interthyr Corp. is their next big success, following on the heels of Diagnostic Hybrids.

Diagnostic Hybrids, a maker of test kits for viral infections and thyroid diseases, was sold for $130 million in January to San Diego-based Quidel Corp. After investing $1 million in Diagnostic Hybrids, OU’s take from the sale was a hefty $35 million.

While there’s plenty of optimism surrounding Interthyr, it’ll be awhile before university officials know what kind of potential they’re sitting on. No human testing of the company’s drug candidate for pancreatic cancer and autoimmune disorders has occurred yet, and it’s unlikely to happen until 2012.

But Interthyr has already started to generate some cash for OU — $20,000 last year — thanks to a test for thyroid disorder Graves’ disease. But it’s the company’s investigational drug that drew a $2.6 million grant from the National Institutes of Health (NIH) and holds the potential to significantly add to the $8.2 million OU earned last year from research licensing — just not for a number of years.

Still, OU’s vice president of research has high hopes for the company. Rathindra Bose told Columbus Business First that licensing revenues from Interthyr could bring “millions” to the university in the future.

In an interview with MedCity News, Bose said Intherthyr’s drug candidate holds “enormous potential” and the company “definitely” could become a Diagnostic Hybrids-like success for OU. “This compound, in my opinion, shows a great deal of promise.”

Interthyr was born in 2000 when researcher Leonard Kohn left the NIH and moved to Athens, Ohio, becoming one of OU’s Innovations Center’s first clients. Kohn began working on the still-unnamed drug to treat autoimmune diseases, then later realized it could also be effective in slowing the growth of cancer cells.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

However, Kohn said the drug’s biggest value is still likely in treating inflammatory autoimmune disorders, such as thyroid disease or diabetes, simply due to the number of patients affected. (A study last year predicted that the number of Americans with diabetes would nearly double to 44 million over the next 25 years.)

With between $5 million and $7 million invested in the drug’s development, Kohn hopes to continue animal testing and then file for an Investigational New Drug Application with the federal government by the end of 2011. That would allow Interthyr to begin testing the drug in humans, with the goal of getting it on the market around 2015, according to Kohn.

The drug works by blocking signals from a Toll-like receptor that initiate an autoimmune response in cells. Interthyr is working with clinical research group Ricerca Biosciences of Concord Township, Ohio, to develop and produce the drug.

In the meantime, Interthyr will continue toxicology testing and studying how the drug works at the molecular level, said Doug Goetz, an OU professor of chemical and biomolecular engineering who’s leading a research team that’s examining the drug’s potential.

While the drug may be a long way from making it to market, it recently achieved an important milestone by passing the Ames Test, which helps determine whether a substance is mutagenic. “There were no problems identified, so that’s definitely a positive sign,” Goetz said.