San Diego-based Organovo (NYSE: ONVO) says a three-dimensional sample of living human liver tissue created with its bio-printing technology was used successfully for the first time to predict that a pre-clinical drug candidate would have a toxic effect on the liver.
In financial results reported yesterday for the company’s fiscal first quarter that ended June 30, Organovo says its 3-D human liver tissue, created in a petri dish, detected the toxicity of a compound that had been deemed to be safe in a standard battery of pre-clinical animal studies and toxicity tests. (The drug’s liver toxicity was discovered after it was given to patients in a clinical trial; Organovo’s tests picked up the problem without having to expose any people to the drug.)
Organovo CEO Keith Murphy says the results suggest that Organovo’s technology could help pharmaceutical companies steer clear of experimental compounds with safety concerns that would otherwise only show up in expensive clinical trials with human patients. He estimates the industry could potentially save billions of dollars if Organovo’s technology proves to be both reliable and consistent.
According to Murphy, the results also put Organovo ahead of rivals that have been working to develop 3-D tissue “spheroids” for use in pre-clinical drug toxicity screening, as well startups that are advancing semiconductor and micro-fluidic technologies capable of mimicking the functions of the liver and other organs. Just last month, for instance, Cambridge, MA-based Emulate raised $12 million in venture funding to advance work on a comprehensive “organ on a chip” and related technology developed at Harvard University’s Wyss Institute.
But so far, such technologies “haven’t come into use, because you can’t get the kind of data from their systems that we get in this kind of study,” Murphy says.
Organovo remains on track with its plans to launch a preclinical testing business for experimental drug compounds before the end of this year. He says the company plans to offer contract research services based on its 3-D human liver tissue technology to drug discovery companies.
A spokeswoman for the company says it is important to note that Organovo’s 3-D human liver tissue consists of different cell types that would be found in a normal human liver. These cells also arrange themselves in the architecture found in a normal liver. When liver cells are not in their native architecture, she says they stop producing cholesterol, albumin, and cytochrome P450, which play different roles in the blood and help to metabolize drugs. Organovo says its 3-D liver tissues produce all three—in contrast, almost all hepatic cell lines now used in cell culture and drug testing, don’t do what normal liver cells do.
In a regulatory disclosure filed two months ago, Organovo says its system can distinguish a toxic compound known to induce liver injury from a closely related chemical known to be non-toxic. In the June 26 statement, Organovo says, “The toxicity of the toxic compound was detected at physiologically relevant doses, an important observation not previously reported with the same compounds in other model liver systems.”
The company says the findings were presented on June 25 at the 3D Cell Culture 2014 conference in Freiburg, Germany, by Adrian Roth, head of mechanistic safety for Roche Pharmaceutical Research and Early Development at the Roche Innovation Center in Basel, Switzerland.
Roth intends to also publish the findings in a peer-reviewed journal, although the company could not elaborate, saying how and where it would be published was entirely up to Roth. He has been overseeing the research under a collaborative agreement in which Roche funds the work conducted by Organovo scientists at the company’s San Diego headquarters.
Organovo’s Murphy sees a sustainable business in developing a suite of three-dimensional human tissues to offer preclinical assessments of drug effects in multiple areas. He says the company has signed multiple collaborative research agreements with pharmaceutical companies and academic medical centers.
Organovo’s financial results, on the other hand, underscore the fragility of the company’s strategy. After going public in 2012 through a reverse merger, Organovo is loaded with debt, bleeding cash, and generating little revenue.
As of June 30, Organovo had available cash of just under $45 million and an accumulated deficit of $98.6 million, according to its fiscal first quarter financial results. The company reported total revenue of $100,000 for the quarter, which was generated mostly from its collaborative research agreements. Meanwhile, Organovo’s operating expenses increased to $6.5 million, a 71 percent increase over the $3.8 million reported for the same quarter last year.
So it’s a good thing when Murphy says the company remains on schedule with its plan to offer preclinical testing services before the end of the year. Organovo needs to generate revenue.
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