Organovo Achieves Key Development Milestones for Its Liver Disease and Intestinal Tissue Models
April 16 2018 - 8:05AM
Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today
announced that along with its collaborators, it has achieved
several breakthrough capabilities for its 3D bioprinted
tissues. At last week’s International Liver CongressTM, two
posters were presented illustrating the Company’s ability to create
functional human liver tissue, produce a spectrum of NASH disease
conditions, and then treat that disease successfully with a
client’s development stage non-alcoholic steatohepatitis (“NASH”)
drug. These posters highlighted the performance of Organovo’s
human liver model in the generation of a robust non-alcoholic fatty
liver disease (“NAFLD”) and NASH phenotype, including the presence
of ‘gold standard’ histopathologic features.
“No other in vitro modeling system allows drug researchers to
explore the evolution of NASH and related treatment strategies
using histology, the only accepted measurement for efficacy, based
on visual confirmation of the cellular disease process under a
microscope,” said Taylor J. Crouch, CEO, Organovo. “Industry
leaders at the International Liver CongressTM spotlighted the need
for measurable ways to explore the efficacy of the approximately
250 NASH drug programs in relevant, translatable human
systems. Organovo’s ExVive® tissue modeling capabilities
represent a major advancement for drug development. We are
particularly excited that we can work with clients to explore their
clinical stage drug candidates, allowing them to address the
patient specific needs of their drugs.”
Organovo continues to map out a range of relevant conditions for
creating NASH, including all components of the disease (fat
accumulation, inflammation and fibrosis). In addition to
assessing donor-specific susceptibility to NAFLD/NASH conditions,
the Company is also systematically testing major reference classes
of compounds targeting NASH to inform treatment strategies.
Ultimately, Organovo’s “patient-on-a-plate” platform allows
researchers to conduct a broad range of high-value profiling
studies in a more relevant, rapid and cost-effective manner than
traditional cell culture and animal models before committing
significant resources to human clinical trials.
Organovo and Merck & Co. (“Merck”) also jointly published a
peer-reviewed study describing the Company’s bioprinted human
intestinal model, which exhibits compelling architecture, barrier
and metabolic functions, while also being able to model key aspects
of toxicity and inflammation.
“The gut model is an exciting addition to our portfolio of
high-value drug modeling platforms,” said Dr. Sharon Presnell,
chief scientific officer, Organovo. “Its performance and
features outshine current in vitro systems, and also has the
potential to facilitate systems biology approaches for the study of
diseases such as NAFLD and NASH, where disease initiation and
progression involve significant interplay between the intestine and
liver.”
About Organovo Holdings, Inc.Organovo is
developing and commercializing a platform technology to produce and
study living tissues that emulate key aspects of human biology and
disease for use in drug discovery, clinical development, and
therapeutic applications. The Company develops tissue systems
through internal research programs and in collaboration with
pharmaceutical, academic and other partners. Organovo's
living tissues have the potential to transform the drug discovery
process, enabling treatments to be developed more effectively and
with greater relevance to performance in human trials and
commercialization. The Company’s ExViveTM Liver and Kidney
Tissues are used in disease modeling for NASH and fibrosis,
high-value drug profiling, target and marker discovery/validation,
and other drug testing. The Company is also advancing a
preclinical program to develop its NovoTissues® liver therapeutic
tissues for critical unmet medical needs, including certain
life-threatening pediatric diseases. The Company has received
orphan designation for its potential treatment of
alpha-1-antityrpsin deficiency, its lead indication within the
category of inborn errors of metabolism. 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. Forward-looking statements include, but are
not limited to, statements regarding the potential for one or more
customer’s electing to move toward framework agreements involving
annual budgets, revenue commitments, and/or dedicated research
plans, the expected costs, timing and operational benefits of the
Company’s restructuring plan, the financial impact of the Company’s
restructuring plan on its future operating costs and financial
results, and statements regarding the potential benefits and
therapeutic uses of the Company’s therapeutic liver tissue.
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 recognize deferred revenue;
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 2018
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 7, 2017. You
should not place undue reliance on these forward-looking
statements, which speak only as of the date that they were made.
These cautionary statements should be considered with any written
or oral forward-looking statements that the Company may issue in
the future. Except as required by applicable law, including the
securities laws of the United States, the Company does not intend
to update any of the forward-looking statements to conform these
statements to reflect actual results, later events or circumstances
or to reflect the occurrence of unanticipated events.
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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