SAN DIEGO, Oct. 20, 2017 (GLOBE NEWSWIRE)
Organovo today presented new preclinical data showing extended survival and sustained functionality of its 3D bioprinted human liver tissue when implanted into diseased animal models. This data will be presented at The Liver Meeting 2017 (American Association For The Study of Liver Diseases or “AASLD”) by Vaidehi Joshi, Scientist I, Therapeutics, at Organovo.
Organovo previously implanted its 3D bioprinted human liver tissue patches onto the livers of healthy NOD/SCID mice, and is now presenting additional data from promising early studies in an established model for alpha-one-antitrypsin deficiency (“A1AT”). The tissue was composed of human hepatocytes and select non-parenchymal cells. Serum and histopathologic evaluation of the implanted therapeutic tissue showed engraftment, retention and a high degree of disease clearing through 125 days post-implantation, a significant increase in duration from the Company’s first preclinical studies, which demonstrated functionality through 28 days. These results demonstrate a significant increase in the reported duration of implanted human hepatocyte synthetic function, demonstrating sustained presence of key human liver proteins such as albumin and A1AT in the animal bloodstream. Importantly, pathologic evaluation of diseased animals receiving implanted bioprinted liver tissues suggests an approximately 75 percent reduction in the pathologic hallmarks of the disease in treated animals versus non-treated control animals in the region of implant.
“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 continues to advance a novel therapeutic solution 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 robust engraftment and durability of the liver tissue and strong early evidence of successfully impacting the disease state in animal models. Taken together, these data support continued preclinical development of Organovo’s 3D bioprinted liver tissue for therapeutic use.”
“The data show that the approach of delivering a 3D bioprinted tissue patch directly to the liver offers great promise in solving the engraftment and integration issues that have held back many cell and gene therapy attempts at these diseases,” said Dr. David Brenner, vice chancellor of Health Sciences and dean of the School of Medicine at UC San Diego, who is also an advisor to Organovo. “We’re encouraged by these solid early results, and are eager to see this work advance to the next stages. UC San Diego’s ability to leverage translational research to understand and redress disease progression is one of the many reasons we’re ideally suited for this kind of collaboration.”
Focusing first on pediatric inborn errors of metabolism, Organovo intends to submit an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for its therapeutic liver tissue in calendar-year 2020. In the next 12 months, the Company expects to optimize its final liver tissue design and continue pre-GLP studies, including efficacy, safety and dosing studies in small animal disease models for IEMs. Organovo is also seeking orphan designation in the U.S. and will partner with contract research organizations (“CROs”) to define and scope IND enabling studies.
Illustration Photo: Bioprinted vascular conduit after 28 days of bioreactor conditioning, highlighting the layered architecture and deposition of extracellular matrix (blue color). Image is Masson’s Trichrome (20x). (Credit: Organovo)