Organovo Publishes Data Describing Physiology of 3D Bioprinted Human Kidney Tissues for Drug Toxicity Testing
February 21 2017 - 8:05AM
Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a
three-dimensional biology company focused on delivering scientific
and medical breakthroughs using its 3D bioprinting technology,
today announced the publication of data in Frontiers in Physiology
showing the company’s 3D bioprinted proximal tubule tissue model
exhibits key characteristics of renal physiology that allow for in
vitro kidney toxicity testing.
“Traditional preclinical models often fall short in their
ability to inform clinical outcomes accurately, largely due to the
limited functionality of simple in vitro models and species
differences,” said Dr. Sharon Presnell, chief scientific officer,
Organovo. “Our newly published data demonstrate that
Organovo’s 3D bioprinted human kidney tissue has great potential to
assess the toxic effects of compounds and the development and
progression of complex, multicellular processes such as
fibrosis.”
Key findings and attributes described in the publication include
the following:
- Immunohistochemical characterization showing tight junction
formation between epithelial cells, polarized expression of
transporters that regulate excretion and reabsorption of compounds,
an extensive microvascular network, and deposition of endogenous
extracellular matrix in the interstitium;
- Proof-of-concept study for demonstrating induction of toxicity
following treatment with a nephrotoxin cisplatin, including a loss
of tissue viability and epithelial cell function in a
dose-dependent fashion. This effect was blocked by
cimetidine, a compound that prevents cisplatin uptake via the
transporter OCT2; and
- Induction of tubulo-interstitial fibrosis in this model via
administration of TGF-beta, with tissue response verified via gene
expression analysis and histological examination of excess
extracellular matrix deposition.
In addition to the kidney publication, the Company noted a
recent article published in ILAR Journal. The publication
explores new technologies that could reduce both dependency on
animal models and occurrence of liver toxicity in clinical
trials. The article, written by scientific executives and
experts from the Food & Drug Administration (“FDA”), Merck
& Co., Inc and LifeNet Health, provides a thorough review of
human tissue models and how they can accelerate drug development
across all discovery stages, including Organovo’s 3D bioprinted
liver model.
The authors reference Organovo’s technology as a “significant
innovation in the study of drug-induced liver injury, as it
addresses many of the shortcomings associated with traditional in
vitro culture models and animal models.” They also state that
3D bioprinted tissues “exhibit a broad range of highly
differentiated in vivo like features and functions.”
The authors reference results from Organovo’s drug-induced liver
injury studies that have shown “very good reproducibility and
concordance with observed outcomes in vivo at the functional and
histological levels” and that treatment of the bioprinted human
liver model with known fibrotic agents “mimicked closely that of
patient liver samples with drug-induced fibrosis.”
“Both liver and kidney drug toxicities are significant
challenges for pharmaceutical companies working to advance safe and
effective therapeutics,” said Mr. Keith Murphy, CEO, Organovo.
“Previous validation data of our 3D bioprinted human liver tissue,
combined with the data published in the peer-reviewed journal,
Frontiers of Physiology, on our 3D bioprinted kidney proximal
tubule tissue, clearly show that Organovo’s technology can address
the unmet needs of our pharma customers and partners by providing
timely, cost-effective, and more accurate human tissue models for
evaluating drug toxicity and drug-induced fibrotic disease.”
Organovo’s publication titled “3D Proximal Tubule Tissues
Recapitulate Key Aspects of Renal Physiology to Enable
Nephrotoxicity Testing,” was published online on February 15, 2017
and can be found on the journal’s website:
http://journal.frontiersin.org/article/10.3389/fphys.2017.00123/abstract
The review titled “The Promise of New Technologies to Reduce,
Refine, or Replace Animal Use while Reducing Risks of Drug Induced
Liver Injury in Pharmaceutical Development,” was published December
31, 2016 and can be found on the journal’s website:
https://academic.oup.com/ilarjournal/article-abstract/57/2/186/2806701/The-Promise-of-New-Technologies-to-Reduce-Refine
About Organovo Holdings, Inc.
Organovo designs and creates functional, three-dimensional
human tissues for use in medical research and therapeutic
applications. The Company develops 3D human tissue models
through internal development and in collaboration with
pharmaceutical, academic and other partners.
Organovo's 3D human tissues have the potential to accelerate
the drug discovery process, enabling treatments to be developed
faster and at lower cost. The Company’s ExVive Human Liver
and Kidney Tissues are used in toxicology and other preclinical
drug testing. The Company also actively conducts early
research on specific tissues for therapeutic use in direct surgical
applications. In addition to numerous scientific
publications, the Company's technology has been featured
in The Wall Street Journal, Time Magazine, The Economist,
Forbes, and numerous other media outlets. Organovo is
changing the shape of life science research and transforming
medical care. Learn more
at www.organovo.com.
Forward-Looking Statements Any statements
contained in this press release that do not describe historical
facts constitute forward-looking statements as that term is defined
in the Private Securities Litigation Reform Act of 1995. Any
forward-looking statements contained herein are based on current
expectations, but are subject to a number of risks and
uncertainties. The factors that could cause the Company's
actual future results to differ materially from current
expectations include, but are not limited to, risks and
uncertainties relating to the Company's ability to develop, market
and sell products and services based on its technology; the
expected benefits and efficacy of the Company's products, services
and technology; the Company’s ability to successfully complete
studies and provide the technical information required to support
market acceptance of its products, services and technology, on a
timely basis or at all; the Company's business, research, product
development, regulatory approval, marketing and distribution plans
and strategies, including its use of third party distributors; the
Company's ability to successfully complete the contracts and
recognize the revenue represented by the contracts included in its
previously reported total contract bookings and secure additional
contracted collaborative relationships; the final results of the
Company's preclinical studies may be different from the Company's
studies or interim preclinical data results and may not support
further clinical development of its therapeutic tissues; the
Company may not successfully complete the required preclinical and
clinical trials required to obtain regulatory approval for its
therapeutic tissues on a timely basis or at all; and the Company’s
ability to meet its fiscal year 2017 outlook and/or its long-range
outlook. These and other factors are identified and described
in more detail in the Company's filings with the SEC,
including its Annual Report on Form 10-K filed with
the SEC on June 9, 2016 and its Quarterly Report on
Form 10-Q filed with the SEC on February 9, 2017. You should
not place undue reliance on these forward-looking statements, which
speak only as of the date that they were made. These
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not intend to update any of the forward-looking statements to
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circumstances or to reflect the occurrence of unanticipated
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Investor Contact:
Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com
Press Contact:
Jessica Yingling
Little Dog Communications
+1 (858) 344-8091
jessica@litldog.com
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