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Stem Cell Co. Closes in on FDA Nod for Pet Treatment

Ever since scientists discovered stem cells are capable of self-renewal, making an unlimited supply of specialized tissue, the promise of using them to treat a variety of diseases has captured many people’s imagination, including serial entrepreneur Tom Yuen.

His Santa Ana-based PrimeGen Biotech LLC has spent the past 15 years trying to develop cell-based therapies and is now inching closer to securing Food and Drug Administration approval by targeting cats and dogs.

Its pet-focused division, VetCell Therapeutics, has partnered with Western University of Health Sciences in Pomona to conduct a preclinical study on treating canine atopic dermatitis with stem cells. It plans to use the data to file for a new-drug application and start clinical trials next year.

Atopic dermatitis is an inflammatory, chronic allergic skin disease. It affects approximately 10% of the canine population, according to a company press release, and can be brought on by immune system dysregulation, skin barrier defects, and environmental factors, such as grass and house dust mites.

The university’s college of veterinary medicine is one of only two veterinary programs in California.

“I was very naive about the FDA approval process,” said Yuen, who acquired PrimeGen in 2002. He said the approval period for veterinary drugs takes a shorter amount of time than that for human drugs. “We changed our main focus to animals, but we remain diligently on [developing] human applications, as well.”

Yuen said the company is privately funded and that he’s the main investor. Computer memory products maker Kingston Technology Inc. founder and President John Tu is also an investor.

Approximately $25 million has been invested to date, Yuen said.

Dual Strategy

VetCell’s therapy uses mesenchymal stem cells—a specific class of stem cells that generate connective tissues, including cartilage, tendons and bone. The cells also modulate the immune system, a property that the company is using to treat atopic dermatitis.

Since announcing the launch of VetCell in 2015, the 25-employee company has started to generate revenue. Yuen declined to provide numbers but said the goal is to create a cash-generating business unit that can help fund human drug development and speed up the human study process because animal study data are required by the FDA before a company can start clinical trials.

VetCell’s therapy is commercially available in the Asia-Pacific region. The company’s canine osteoarthritis drug, administered as an intra-articular injection, launched commercially in Hong Kong early this year. It plans to add atopic dermatitis to its offerings early next year.

The company is also working to broaden its patient pool to include cats. Yuen said the company plans to use cell therapy to treat feline gingivitis; mouth and gum inflammation are common in cats.

“There are a high population of dogs and cats in Asia,” he said, noting that the number is comparable to the U.S., where there are over 180 million, according to a survey conducted by the American Pet Products Association. Basic annual expenses for dogs are $1,500 each, and $550 each for cats.

The company’s Asia headquarters is in Hong Kong.

Human Work

While VetCell is focused on treating a wide range of pet ailments, including severe pain and inflammation resulting from osteoarthritis and autoimmune diseases, Yuen said the company will continue furthering cell therapy for human use at its 11,500-square-foot headquarters in Santa Ana.

The facility functions primarily as a research lab. The company says it complies with the FDA’s current good-manufacturing practice regulations, and Yuen said the company is careful to keep human and animal works separate to avoid cross-contamination.

Yuen, whose background is in electrical engineering, got into the field because he was fascinated by the “curative potential” of using stem cells to treat his own disease.

“My disease is hereditary … I am probably one of the longest surviving dialysis patients. Even though the disease makes it a very challenging life [for me], I’d like to make a contribution to the chronic kidney disease area,” he said.

Yuen majored in electrical engineering at the University of California-Irvine. He founded several publicly traded companies, including AST Research Inc., one of the world’s leading personal computer manufacturers and a member of the Fortune 500.

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