Organovo Presents New Preclinical Data on 3D Bioprinted Human Liver Tissues for the Treatment of Inborn Errors of Metabolism ...
October 20 2017 - 8:05AM
Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today
presented new preclinical data showing extended survival and
sustained functionality of its 3D bioprinted human liver tissue
when implanted into diseased animal models. This data will be
presented at The Liver Meeting 2017 (American Association For The
Study of Liver Diseases or “AASLD”) by Vaidehi Joshi, Scientist I,
Therapeutics, at Organovo.
Organovo previously implanted its 3D bioprinted human liver
tissue patches onto the livers of healthy NOD/SCID mice, and is now
presenting additional data from promising early studies in an
established model for alpha-one-antitrypsin deficiency (“A1AT”).
The tissue was composed of human hepatocytes and select
non-parenchymal cells. Serum and histopathologic evaluation of the
implanted therapeutic tissue showed engraftment, retention and a
high degree of disease clearing through 125 days post-implantation,
a significant increase in duration from the Company’s first
preclinical studies, which demonstrated functionality through 28
days. These results demonstrate a significant increase in the
reported duration of implanted human hepatocyte synthetic function,
demonstrating sustained presence of key human liver proteins such
as albumin and A1AT in the animal bloodstream. Importantly,
pathologic evaluation of diseased animals receiving implanted
bioprinted liver tissues suggests an approximately 75 percent
reduction in the pathologic hallmarks of the disease in treated
animals versus non-treated control animals in the region of
implant.
“With tens of thousands of patients being treated for inborn
errors of metabolism (“IEMs”) in the U.S., and an annual cost per
patient that exceeds $250,000 for drug therapy alone, Organovo
continues to advance a novel therapeutic solution for direct
surgical implantation,” said Eric David, M.D., J.D., chief
strategy officer and executive vice president of preclinical
development, Organovo. “Our preclinical data continues to show
robust engraftment and durability of the liver tissue and strong
early evidence of successfully impacting the disease state in
animal models. Taken together, these data support continued
preclinical development of Organovo’s 3D bioprinted liver tissue
for therapeutic use.”
“The data show that the approach of delivering a 3D bioprinted
tissue patch directly to the liver offers great promise in solving
the engraftment and integration issues that have held back many
cell and gene therapy attempts at these diseases,” said Dr. David
Brenner, vice chancellor of Health Sciences and dean of the School
of Medicine at UC San Diego, who is also an advisor to Organovo.
“We’re encouraged by these solid early results, and are eager to
see this work advance to the next stages. UC San Diego’s ability to
leverage translational research to understand and redress disease
progression is one of the many reasons we’re ideally suited for
this kind of collaboration.”
Focusing first on pediatric inborn errors of metabolism,
Organovo intends to submit an Investigational New Drug (“IND”)
application to the U.S. Food and Drug Administration (“FDA”) for
its therapeutic liver tissue in calendar-year 2020. In the next 12
months, the Company expects to optimize its final liver tissue
design and continue pre-GLP studies, including efficacy, safety and
dosing studies in small animal disease models for IEMs. Organovo is
also seeking orphan designation in the U.S. and will partner with
contract research organizations (“CROs”) to define and scope IND
enabling studies.
The Company’s posters are as follows:
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Title: |
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Long-Term Performance of Implanted Bioprinted Human Liver
Tissue in a Mouse Model of Human Alpha-1 Antitrypsin
Deficiency |
Date: |
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Saturday,
October 21, 5:30 - 7:00 pm - Hall D |
Poster: |
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805 |
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Title: |
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Modeling NAFLD Using 3D Bioprinted Human Liver
Tissue |
Date: |
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Monday,
October 23, 12:30 - 2:00 pm - Hall D |
Poster: |
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1963 |
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About Organovo Holdings, Inc.
Organovo designs and creates functional, three-dimensional human
tissues for use in drug discovery, clinical development, and
therapeutic applications. The Company develops 3D human tissue
systems through internal research programs and in collaboration
with pharmaceutical, academic and other partners. Organovo's 3D
human 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 Human Liver and Kidney
Tissues are used in high-value drug profiling, including compound
screening in disease models, toxicology, target and marker
discovery/validation, and other drug testing. The Company is also
advancing a preclinical program to develop liver therapeutic
tissues for critical unmet medical needs, including certain
life-threatening pediatric diseases. 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. Forward-looking statements include, but are not
limited to, statements regarding the potential benefits and
therapeutic uses of the Company’s therapeutic liver tissue; the
Company’s ability to successfully complete additional preclinical
studies, development activities and clinical trials for its
therapeutic liver tissue; and the Company’s development and
regulatory plans and timeline. 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; the risk of
further adjustments to the Company’s preliminary revenue results
for the second quarter of fiscal 2018; the Company’s ability to
control the costs and to achieve the expected operational benefits
and long- term cost savings of its previously announced
restructuring plan; 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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