Medford, MA, November 2, 2011 - At the annual meeting of the International Society for the Study of Xenobiotics (ISSX), Hepregen Corporation, and two of its pharmaceutical customers, Boehringer Ingelheim Pharmaceuticals, Inc. and Elan Pharmaceuticals presented new preclinical data in poster presentations that tested Hepregen's proprietary microliver technology platform, HepatoPac™, for predicting clearance of drugs which are slowly removed by the liver. Of the commercially available drugs tested, 89 percent were predicted correctly (within two-fold of reported clinical values), while the remaining drugs were within three-to-four fold. Suspension hepatocytes typically used for this type of study do not turn over these drugs sufficiently to make this determination.
These data demonstrated that Hepregen's HepatoPac liver model can be used effectively to predict the clearance of low turnover drugs in humans.
HepatoPac addresses the significant need in the pharmaceutical industry for increasing confidence in the data packages that are used to prioritize compounds in the pipeline. Hepregen, a leading provider of bioengineered solutions that increase success in drug development in order to improve patient safety, presented these results with partners at ISSX held in Atlanta, Georgia.
"Hepregen's goal is to develop and provide bioengineered solutions to our partners that reduce risk in drug development and lead to safer drugs. The data presented at the ISSX meeting provide further validation, positioning HepatoPac to become the industry standard for reducing attrition rates caused by liver liability," commented Co-Founder, President and Chief Executive Officer, Bernadette C. (Bonnie) Fendrock. "We are pleased to have our partners present their research progress."
The short lifetime (hours) of routinely used suspension hepatocytes in pharmaceutical practice prevents accurate prediction for low clearance drugs. Low clearance drugs that provide efficacy with administration of one pill per day are generally preferred by discovery project teams for further development.
At the annual meeting, some scientists reported that donor-dependent variability in clearance predictions using HepatoPac liver platform was markedly lower than that seen in routinely used suspension hepatocytes. Scientists from Elan Pharmaceuticals further showed that the in vivo clearance of ELND006, a central nervous system drug candidate which did not turn over in conventional models to any significant degree and showed low turnover in Phase I clinical trials, could be predicted in vitro using HepatoPac microliver platform.
Also at the ISSX meeting, Hepregen Co-Founder, Dr. Salman Khetani, chaired the opening plenary session and gave a presentation on the Company's technology titled, "Engineered Tissue Models For In vitro and In vivo Metabolism and Toxicity Testing."
About HepatoPac MicroLiver Platform
The technology behind HepatoPac creates a microenvironment where primary hepatocytes (both human and animal) remain viable and physiologically functional for several weeks. Hepatocytes in traditional cultures begin to lose their functions within hours of being put into culture. The long term stability and biochemical fidelity of HepatoPac allow for transporter, metabolism and toxicity studies that mimic in vivo situations. A whitepaper on the technology is available at: http://www.hepregen.com/events.
About Hepregen Corporation
Hepregen's mission is to translate the value of its technology platform to improve the safety and efficacy of drugs in development with greater economic efficiency and significant impact on patients' lives. The company is focused on advancing and commercializing its microliver platform, HepatoPac™, into the drug-development pipeline of pharmaceutical and biotechnology companies. Hepregen's platform technology offers the potential to deliver a breakthrough technology for toxicity screening and a new platform for drug discovery. It combines sophisticated biological and engineering technologies to create an in vitro liver model which closely mimics many key functions and features of the human liver.
Hepregen provides access to its HepatoPac technology (human and animal) through its contract research services business, which includes offerings in Drug Metabolism & Pharmacokinetics, Safety and Efficacy, and through licensing opportunities.
Currently, Hepregen has partnered with over 20 pharmaceutical companies using the HepatoPac technology, including Boehringer Ingelheim Pharmaceuticals, Inc., Elan Pharmaceuticals, Pfizer, Alnylam Pharmaceuticals and Sanofi-Aventis. In 2008, Battelle Ventures spun out Hepregen Corporation from the Massachusetts Institute of Technology (MIT), and led the company's Series A financing.
For more information about Hepregen, please visit:http://www.hepregen.com/
Precise micropatterning in HepatoPac creates a defined architecture of hepatocyte islands surrounded by stromal cells. The patterning creates a microenvironment where primary hepatocytes from multiple species (human, rat, monkey and dog) retain physiological functions for several weeks.
Hepatocyte colonies in HepatoPac form a defined bile canalicular network, allowing for accurate modeling of drug transport in the liver.
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Bonnie Fendrock, President & CEO