Human liver tissue. Image source: Getty Images.
Hundreds of thousands of scientific articles are published in journals every year. How important are they? It depends on how groundbreaking the findings are.
The recent publication by Organovo (ONVO) and Roche (RHHBY -2.24%) researchers in the scientific journal PLOS One is an example of a major milestone. But while the information presented wasn't surprising, the paper could be a big boon for Organovo.
Findings
In a research article published in PLOS One on July 7, scientists from Organovo and Roche detailed how Organovo's 3D bioprinted human liver tissue was able to model drug-induced liver injury and differentiate between similar compounds with very different levels of toxicity. Those compounds were antibiotics levofloxacin and trovafloxacin. Levofloxacin is nontoxic, while trovafloxacin can lead to liver failure.
The researchers used 3D bioprinted human liver tissue to model tissue-level drug-induced liver injury. To do this, they compared the dose responses of trovafloxacin and levofloxacin. What was the verdict? The research team was able to demonstrate the toxicity of trovafloxacin at clinically relevant doses.
None of these results were out of left field. Organovo had already presented similar findings at the Society of Toxicology's annual meeting in March. In April 2015, the company presented results from an another study where its 3D liver tissue was used to detect toxicity of diabetes drug Rezulin.
Why it matters
At first glance, the publication from Organovo's and Roche's research doesn't seem like such a big deal. For Roche, it isn't. But for Organovo, the PLOS One paper represents another key step toward building a still relatively new market for 3D bioprinted human tissues.
It's important to understand the background of trovafloxacin. Pfizer launched the drug under the brand name Trovan in 1998. The big drugmaker expected Trovan to eventually generate annual sales of as much as $1 billion. But it wasn't to be.
Truvan was withdrawn from the market in Europe after multiple people died from liver failure after taking the drug. Since 1999, the antibiotic has only been available in the U.S. for emergency use. Rezulin's story is similar. First approved by the FDA in 1997, Rezulin was taken off the market in 2000 after being linked to deaths resulting from liver failure.
In both cases, clinical studies failed to detect the potential for liver damage with the drugs. The end results were millions (and even billions) of dollars lost -- and patient deaths.
Organovo hopes that studies like the one recently published will help drugmakers appreciate the value of 3D bioprinted tissues. Between 1990 and 2010, there were 39 drugs withdrawn from the market. Ten of those drugs caused liver damage, but the toxicity wasn't picked up in testing. Another 13 drugs caused cardiovascular problems.
Drug testing using conventional 2D cell culture models has two primary drawbacks. First, 2D models don't last long. Second, they don't replicate the complicated cell-cell interactions and environment of human tissue. Animal testing doesn't always pick up drug toxicity in humans because of species variation and other factors.
Those limitations should give 3D bioprinted human tissue a competitive advantage -- if the word gets out loud and clear. Studies like the one just published will help in Organovo's effort to make sure the right people know the story.
What's next for Organovo
Expect Organovo to trumpet the latest findings everywhere it can. I suspect that the research will help the company in its sales efforts.
On the other hand, don't expect Organovo to turn the corner on profitability just yet. The company reported a loss of $38.6 million in fiscal year 2016. While Organovo expects a significant jump in revenue in fiscal 2017 (perhaps as high as $6 million), it won't be nearly enough to make for a positive bottom line. For now, Organovo remains a stock to consider mainly for the potential of its technology.
