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Organovo Discloses First Preclinical Data on Human Liver “Patch”

Xconomy San Diego — 

After taking the first steps toward the development of living human liver tissue “patches” for therapeutic use, San Diego-based Organovo (NASDAQ: ONVO) is laying out its pre-clinical data for the first time today. And the company says the results are promising enough to warrant further development of the technology.

Organovo CEO Keith Murphy said in October that the company intends to use its 3D bio-printing technology to produce living human liver tissue for transplantation in patients with fatal liver disease. The company said human liver tissue made with Organovo’s bio-printing technology could help improve the function of a patient’s failing liver until a donor liver is available.

According to Organovo, there are about 17,000 patients in the United States awaiting a liver transplant, but only about 6,000 liver transplants are performed each year. The company, officially known as Organovo Holdings, said it is initially targeting children with metabolic liver diseases and people with “acute-on-chronic liver failure,” an orphan disease characterized by the rapid deterioration of liver function.

In a statement this morning, Organovo says results of the study, which are set to be reported today at the annual meeting of the Tissue Engineering and Regenerative Medicine International Society (TERMIS) in San Diego, show that 3D bio-printed human liver patches maintained their structure and function after being implanted onto the livers of mice. Human albumin and other key human liver proteins produced by the tissue were detected in the blood of mice for at least 28 days following the implantation.

“The presence of these enzymes provides an important first step in demonstrating the capability of this tissue to treat inborn errors of metabolism, a key indication we are targeting,” says Organovo’s Eric David in the company’s statement. The results are an important first step in demonstrating the therapeutic promise of bio-printed liver tissue, says David, who is Organovo’s chief strategy officer and an executive vice president.

In response to a question from Xconomy, David says the mice used in the preclinical studies do not have a functioning immune system. As the use of 3D bio-printed liver tissue moves into clinical trials, immunosuppression drugs like those used for liver transplants would likely be used.

Organovo says it intends to submit an investigational new drug application to the FDA in three to five years for therapeutic use of its bio-printed liver tissue. If appropriate, the company says it would pursue a breakthrough therapy designation, clinical development outside the United States, and other opportunities to help accelerate its time to market.