SOURCE: Hepregen Corporation

Hepregen Corporation

April 30, 2014 10:00 ET

Hepregen Launches Human HepatoMune™ Assay Kit to Evaluate Inflammation-Mediated Hepatotoxicity in the Laboratory

Predicting Liver Injury Mediated by Drug or Biologic Interactions with Immune and Liver Cells

MEDFORD, MA--(Marketwired - April 30, 2014) - Hepregen Corporation, a leader in the development of next generation HepatoPac™ cell-based in vitro assay products, today announced the commercial launch of the company's first human HepatoMune™ micro-liver assay kit. The kit is designed specifically to predict toxicologic outcomes caused by the interaction of drugs and/or biologics with an inflamed liver. The kit contains one or more standard 96-well tissue culture plates featuring specially configured micro-patterned human liver cells (hepatocytes) co-cultured with stromal cells to which fully functional human liver immune cells (Küpffer cells) are added.

Like their macrophage counterparts in the circulation, Küpffer cells located in the liver can engulf foreign invaders and macromolecules such as proteins. Moreover, these cells can also be stimulated to release cytokines as a result of interactions with inflammation-inducing agents. Cytokines, which are cell-signaling proteins of the immune system, can interact with small chemical entities or their metabolites, provoking damage to hepatocytes. The Küpffer cells and hepatocytes in HepatoMune™ plates together mirror the interactive behavior of these two cell types in the body. The human HepatoMune™ kit provides a tool to researchers that can be used in the laboratory to generate data useful for: (1) identifying potential inflammation-mediated liver toxicity resulting from exposure to chemical or biological agents, (2) studying mechanisms of toxicity, and (3) evaluating the potential for drug-drug and drug-biologic interactions that can be harmful to liver tissue. Consequently, these data can be useful for prediction of toxic responses to chemical agents, including drug candidates and biological agents such as monoclonal antibodies or recombinant proteins used for therapy.

Jack McGeehan, Hepregen's Vice President of Operations, stated, "The development of this new HepatoMune™ product has taken nearly two years. As with all our products, its performance characteristics and demonstrated utility is backed by hundreds of hours of research undertaken in collaboration with several of our pharmaceutical company customers."

Dr. Vincent Zurawski, Hepregen's Chief Executive Officer added, "This first human HepatoMune™ kit is our second application-directed kit focused on the in vitro toxicology market. It is the first kit that provides for the addition of a third cell type to Hepregen's micro-patterned co-culture HepatoPac™ platform, which contains hepatocytes and stromal cells organized to mimic hepatocyte behavior in the liver. The introduction of this kit to the marketplace represents another step in Hepregen's ongoing commitment to providing our customers with high quality tools useful in solving product development problems and reducing associated development costs." 

About Hepregen Corporation

Hepregen Corporation is a leader in innovating unique and proprietary bioengineered micro-liver platforms for use in environmental testing, preventive care, and product development in the pharmaceutical and biopharmaceutical, diagnostic, cosmetics, and chemical industries. The company's micro-liver HepatoPac™ and HepatoMune™ cell-based assays are intended to drive a paradigm shift in drug development. The utility of Hepregen's human, rat, monkey, dog, and multi-species/multi-donor HepatoPac™ and HepatoMune™ application-directed products has been validated in collaboration with investigators at several well-known pharmaceutical companies. Additionally, new applications for these products are being tested by Hepregen, its pharmaceutical company customers, and its academic and business partners. Hepregen was founded and capitalized by Battelle Ventures and Innovation Valley Partners with technology licensed from the Massachusetts Institute of Technology. The technology was developed by Professor Sangeeta Bhatia, who is a world renowned expert and leader in liver bioengineering for life science and therapeutic applications.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements. Such forward-looking statements reflect Hepregen's expectations about its future operating results, performance and opportunities that involve substantial risk and uncertainties. These statements include but are not limited to statements regarding the performance and results of the company's HepatoPac™ and HepatoMune™ application-directed kits. When used herein, the words "anticipate," "believe," "estimate," "upcoming," "plan," "target," "intend," "predict" and "expect" and similar expressions, as they relate to Hepregen or its management are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to Hepregen and are subject to a number of risks, uncertainties and other factors that could cause Hepregen's actual results, performance, prospects and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. Hepregen assumes no obligation to update any such forward-looking statements.

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