Organovo is a well-known company to anyone involved in 3D printing, tissue engineering or both. While many are familiar with the company’s 3D printed liver and kidney tissues, however, it’s still hard to keep up with the momentum of Organovo and their technology. The bioprinting company has released several sets of promising data from studies of their exVive 3D printed tissue already this year, and now Organovo has presented new data showing that the 3D printed tissue is capable of surviving and functioning inside an animal test subject.The data was presented by Benjamin Sheperd, PhD, Organovo’s Director of Therapeutics, at the World Advanced Therapies and Regenerative Medicine Congress in London this week. Previously, Organovo implanted patches of their 3D printed liver tissue onto the livers of healthy NOD/SCID mice, and the new data reflects early studies of treatment for alpha-one-antitrypsin deficiency, a genetic disorder that can cause lung or liver disease.
Alpha-one-antitrypsin deficiency occurs when the body does not make enough of a protein that protects the lungs and liver from damage, leaving them vulnerable to conditions such as emphysema and cirrhosis. Lung and liver disease can occur in unusually young patients, often before the age of 40, if they have the disorder.
The tissue, composed of human hepatocytes and select non-parenchymal cells, was implanted into animal test subjects with the deficiency. 60 days after being implanted, the tissue showed engraftment, retention and sustained functionality. This was a major improvement from an earlier trial in which the tissue demonstrated functionality for 28 days. Pathologic evaluation of the animals treated with the bioprinted tissue suggested improved liver health as compared to a control group of animals with the same disorder who did not receive the treatment.
“With tens of thousands of patients being treated for inborn errors of metabolism (‘IEMs’) in the U.S., and an annual cost per patient that exceeds $250,000 for drug therapy alone, Organovo is advancing novel therapeutic solutions for direct surgical implantation,” said Eric David, M.D., J.D., Chief Strategy Officer and Executive Vice President of Preclinical Development, Organovo. “Our preclinical data continues to show increased durability of the liver tissue and strong early evidence of successfully impacting the disease state in animal models. The robust presence of key human metabolic enzymes, which we previously disclosed, is also a critical step in demonstrating the capability of this tissue to treat IEMs, a key indication we are targeting. Taken together, these data support continued preclinical development of Organovo’s 3D bioprinted liver tissue for therapeutic use.”
Organovo plans to submit an Investigational New Drug application to the US Food and Drug Administration for its 3D bioprinted liver tissue in the year 2020. Over the next year and a half, the company plans to optimize the final design of the 3D printed liver tissue and continue pre-GLP studies, including efficacy, safety and dosing studies in small animal disease models for inborn errors of metabolism. Organovo plans to focus first on pediatric IEMs, and is also planning to seek orphan designation in the US and partner with contract research organizations to define Investigational New Drug enabling studies. Discuss in the Organovo forum at 3DPB.com.
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