Organovo Presents New Preclinical Data on 3D Bioprinted Human Liver Tissues at World Advanced Therapies and Regenerative Medi...
May 18 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 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 was presented
at the World Advanced Therapies and Regenerative Medicine Congress
in London by Benjamin Sheperd, Ph.D., Director of 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 data from promising early studies in an established
model for alpha-one-antitrypsin deficiency. 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 sustained functionality of the
bioprinted cellular organization through 60 days post-implantation,
a significant increase in duration from the Company’s first
preclinical studies, which demonstrated functionality through 28
days. Importantly, these results demonstrate a significant increase
in the reported duration of transplanted human hepatocyte synthetic
function, and suggest that synthetic function is improved in the
animal disease model. Pathologic evaluation of diseased animals
receiving transplanted bioprinted liver tissues suggests an
improvement in liver health versus non-treated, control
animals.
“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 is
advancing novel therapeutic solutions 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 increased
durability of the liver tissue and strong early evidence of
successfully impacting the disease state in animal models. The
robust presence of key human metabolic enzymes, which we previously
disclosed, is also a critical step in demonstrating the capability
of this tissue to treat IEMs, a key indication we are targeting.
Taken together, these data support continued preclinical
development of Organovo’s 3D bioprinted liver tissue for
therapeutic use.”
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 18
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
will also seek orphan designation in the U.S. at the appropriate
time and partner with contract research organizations (“CROs”) to
define and scope IND enabling studies.
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 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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