A Cell-Based Solution to Toxicity Testing

More than 6,000 Americans suffer drug toxicity each day in hospitals. And sadly, nearly 80,000 children are admitted to hospitals as a consequence of such adverse drug reactions, with almost 40% of such cases classified as ‘life-threatening’.

Acetaminophen, the active ingredient in Tylenol, is one of the main culprits. In 2004 and 2005 alone acetaminophen has caused 51% of all acute liver failure. It is the most commonly used pharmaceutical analgesic and antipyretic agent in the world.

What’s more, the inability to accurately predict toxicity early in drug development cost the pharmaceutical industry a record $8 billion in just one year, 2003. In particular, hepatotoxicity, or liver damage caused by medications and other chemical compounds, is the single most common reason leading to drug withdrawal or refusal of drug approval by the FDA. In fact, about one third of all potential drugs fail pre-clinical or clinical trials due to the toxic nature of the compounds being tested, accounting for an estimated $70 million (20%) of total research and development costs per drug.

Even though all drugs must go through testing for absorption, distribution, metabolism, excretion, and toxicology prior to approval, there is still no absolute effective way to test a compound’s safety on human livers. And it’s for the same reason that no bio-artificial liver has been developed till now – scientists haven’t been able to create hepatocytes (liver cells) that mimic a human liver and are stable in a laboratory.

The PICM-19 cells grown in vitro synthesize liver specific proteins such as albumin and transferrin, and display enhanced liver-specific functions such as ureagenesis and cytochrome P450 activity. As a result, HepaLife, using the patented PICM-19 cell line, plans to develop proprietary in vitro toxicological and pre-clinical drug testing platforms that will more accurately determine the potential toxicity and metabolism of new pharmacological compounds in the liver.