Organovo to Present New Preclinical Data on 3D Bioprinted Human Liver Tissues for the Treatment of Tyrosinemia I at the Liver...
October 15 2018 - 8:05AM
Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology
company pioneering the development of 3D bioprinted tissues aimed
at treating a range of serious adult and pediatric liver diseases,
today announced it will present data on the performance of its
liver therapeutic tissue in an animal model of hereditary
tyrosinemia Type 1 (“HT-1”) at the Liver Meeting
2018
® (American Association for the Study of Liver
Diseases or “AASLD”) being held November 9-13, 2018 in San
Francisco. The Company will also have a poster presentation
comparing the performance characteristics of liver cells in an in
vitro setting between non-diseased and non-alcoholic fatty liver
disease (“NAFLD”) donors. The abstracts are available in the
Online Planner on the AASLD website.
Organovo implanted its 3D bioprinted human liver tissue patches
onto the livers of FRG knockout mice, and is presenting data from
promising early studies in this established model for HT-1, an
inborn error of metabolism (“IEM”) characterized by severe liver
damage due to increased tyrosine levels. The liver tissue
patches are composed of human hepatocytes and select
non-parenchymal cells. Serum and histopathologic evaluation
of the implanted therapeutic tissue showed engraftment, retention
and functionality through at least 35 days post-implantation, while
also demonstrating the sustained presence of key human liver
proteins such as albumin in the animal bloodstream.
Importantly, treated animals showed an improvement in the median
survival rate versus non-treated control animals.
“We’re encouraged that our 3D bioprinted liver tissues continue
to show retention and functionality in a range of animal disease
models, including Alpha-1-antitrypsin deficiency and HT-1, where
there is critical unmet need and a potentially significant impact
on patient outcomes because of the dire shortage of liver
transplants,” said Taylor J. Crouch, CEO, Organovo. “In each
case, our objective in implanting a healthy tissue patch is to
restore function or offset the deficiency of a specific enzyme
abnormality, with the ultimate goal of delaying or reducing the
need for a transplant. We remain on track for our first IND
submission in calendar 2020.”
Referring to the poster presentation, Dr. Sharon Presnell, chief
scientific officer, Organovo, commented, “As we continue to build
our library of healthy and diseased liver tissues and isolated
primary cells, we are uncovering key functional and genetic
features of cells that correlate with specific donor and
disease-state attributes. The data to be presented at AASLD
highlights Samsara’s leadership in the isolation and specialized
characterization of NAFLD/NASH-origin primary human liver cells,
contributing to a better understanding of liver disease and its
potential treatments.”
The Company’s poster(s) and oral presentation are as
follows:
Title: |
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The Performance
Characteristics of Isolated Human Liver Cells
Correlate |
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with Donor
Attributes in a Cohort of Tissues from Non-Diseased
and |
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NAFLD
Donors |
Date: |
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Saturday, November 10,
2018, 2:00 pm PT – Moscone Center North/South |
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Building, Hall C |
Publication: |
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1305 |
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Title: |
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Long-Term
Performance of Implanted Bioprinted Human Liver Tissue in
a |
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Mouse Model of
Tyrosinemia I (Oral Presentation) |
Date: |
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Sunday, November 11,
2018, 11:30 am PT – Moscone Center North/South |
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Building, Room
214/216 |
Publication: |
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0083 |
About Organovo Holdings, Inc.Organovo is a
biotech platform company that has developed a leadership position
with its revolutionary ability to 3D bioprint tissues with human
functionality. The Company is pursuing multiple IND-track
programs to develop its NovoTissues® to address a number of serious
unmet medical needs in adult and pediatric populations, initially
focusing on liver disease. Organovo’s first IND-track program
for Alpha-1-antitrypsin deficiency recently received orphan drug
designation from the FDA, and the Company expects to file its first
IND in 2020. In order to support its plan to initiate
multiple IND-track programs, the Company is providing access to its
ExVive™ in vitro tissue disease modeling platform to facilitate
high value drug discovery and development collaborations.
Organovo’s wholly-owned subsidiary, Samsara Sciences, provides the
Company and its clients with high quality human liver and kidney
cells for research applications. 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,
including the benefits of an orphan designation; the Company’s
expectations regarding the FDA regulatory pathway and anticipated
timelines for its regulatory filings; the potential market
opportunity for the Company’s therapeutic tissue candidates; and
customer demand for and acceptance of its disease modeling and
other in vitro tissue platforms. 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 possibility that 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; risks that
competitive products may adversely impact the market opportunity
for the Company’s therapeutic tissue candidates; 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 execute framework agreements involving multi-year commitments
and routine use on a timely basis, or at all; 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; and the Company’s ability to meet its fiscal-year
2019 goals and 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 May
31, 2018. 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 & Press Contact:
Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com
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